The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
Alcon - Summit/Autonomous (Includes Recalls) PDF Print E-mail
Thursday, 14 September 2006 14:47

Alcon - Summit/Autonomous

Alcon LADARVISION 4000 Safe? Don't Think So...

 

Filed August 20, 2008

Reed v Alcon

Manufacturers beware, you are deserving of many CLASS-ACTION LAWSUITS!

The recalls listed below are too little, too late:

  Alcon Warns Surgeons of Central Islands

Alcon RefractiveHorizons, Inc. (Fort Worth, TX) has issued a safety alert for the Ladar6000 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX). According to spokeswoman Kathleen Golden, the company directed surgeons to discontinue using the laser for myopic CustomCornea procedures (Alcon Laboratories, Inc.) after seven surgical centers reported an increased presence of topographically observed central islands in treated patients. No safety alerts were issued for other procedures performed with the laser, Ms. Golden said in an interview with Cataract & Refractive Surgery Today. The Ladar6000 first received FDA approval in May 2006.

Alcon has alerted the FDA to the safety concern and also has submitted a Premarket Approval supplement that proposes the issue could be resolved by reversing the direction of the laser's ablation pattern and resetting its repetition rate to 60 Hz.

Approximately 100 units have been affected by this alert, including 12 outside the US in Spain, Portugal, Italy, and other countries, Ms. Golden said.

"We are currently asking physicians to provide any information they have that might help further our investigation," she said. "We will continue to work diligently with the FDA to resolve the issue."

SOURCE

Class 1 Recall: Alcon Refractive Horizons, Inc. LADAR6000™ Excimer Laser System

Date Recall
Initiated February 21, 2007

Product: LADAR6000™ Excimer Laser System for CustomCornea® algorithm for myopia with astigmatism (M3), and myopia without astigmatism (A7)

Use: The LADAR6000™ Excimer Laser System is used for LASIK and wavefront-guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism and for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months. The cornea is the clear (transparent) dome-shaped front portion of the outer covering of the eye.

Recalling Firm: Alcon Refractive Horizons, Inc.
2800 Discovery Dr.
Orlando, Florida 32826-3010

Reason for Recall: The use of Alcon Refractive Horizon, Inc.’s CustomCornea® algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7) with the LADAR6000™ Excimer Laser caused corneal abnormalities (“central islands”). It also resulted in decreased visual sharpness (visual acuity). These “central islands” may not be correctable with lasers. Additionally, the decrease in visual acuity may not be correctable with glasses or contact lenses.

This recall is limited to the CustomCornea® algorithms described above, and not the entire LADAR6000™ device.

Public Contact: Patients with questions can call the company at 1-877-523-2784.

FDA District: Florida

FDA Comment: From August 17, 2005, through February 21, 2007, Alcon Refractive Horizon, Inc. distributed 102 units worldwide with approximately 89 of those units distributed in the U.S. Eighteen are held in Alcon’s possession and two are being held by the freight handler.

Alcon first notified doctors on February 21, 2007 of the problem via letter and recall notice, directing doctors to stop using the CustomCornea® algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7).

On May 11, 2007, Alcon updated doctors in a letter stating that Alcon will deactivate their device’s ability to perform CustomCornea® Myopia and CustomCornea® Myopia with astigmatism procedures. Alcon has completed deactivation of these two algorithms in all LADAR6000™ lasers in service in the U.S.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online: www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

FAX: 1-800-FDA-0178

www.osnsupersite.com/view.asp?rID=22422

Alcon has officially completed the deactivation of two algorithms used for CustomCornea treatment of myopia with or without astigmatism, the U.S. Food and Drug Administration announced.

The algorithms were recalled in February in response to reports of corneal abnormalities or "central islands" that may not be correctable with laser therapy. Use of the algorithms has also been linked with a decrease in visual acuity that may not be correctable with glasses or contact lenses, the FDA said.

Health care professionals were notified of the problem in a Feb. 21 letter and recall notice and were directed to no longer use the LADAR6000 units to perform CustomCornea LASIK for myopia. On May 11, they were advised by the FDA that Alcon would be willing to deactivate the device's ability to perform these procedures.

FDA Warning Letter to Alcon

SOURCE

555 Winderley Pl., Ste. 200

Maitland, FL 32751

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-05-27

April 15, 2005

Mr. Gary A . Woodrell

Vice President

Refractive Manufacturing Operations

Alcon Laboratories, Inc.

2501 Discovery Drive

Orlando, Florida 32826

Dear Mr. Woodrell :

During an inspection of your establishment located in Orlando, Florida on January 10 - 18, 2005, our Investigator determined that your firm manufactures the LADARVision 4000 Excimer Laser System. An excimer laser is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)].

The above-stated inspection revealed that this device is adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate as required by 21 CFR 820.198(b). (FDA 483, Item #1).

Data downloaded from LADARVision systems currently in use in the U.S. showed significant differences in the retreatment requirements between patients treated prior to 15 minutes after calibration of the device as opposed to patients who were treated after 15 minutes following calibration of the device. Another table was provided that used the points of < 30 minutes from calibration to treatment and > 30 minutes or more from calibration to treatment.

 

A patient whose surgical procedure is initiated after 30 minutes has a 30% greater risk of retreatment than does the patient whose treatment commences prior to 30 minutes after calibration. Beam drift occurs if too much time passes between calibration and treatment, with possible translation or rotation of the beam.

 

Your response to this data has been inadequate. There is a note to a warning to the device user manual, which states, "WARNING: System calibration must be done between patients and within 15 minutes of surgery, failure to perform calibration in the time frame indicated may result in improper orientation of the ablation. " However, there was no reason provided to explain the use of these times. Moreover, the note to warning is not by itself sufficient to address the seriousness of this problem . (FDA 483, Item #1)

 

2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is necessary as required by 21 CFR 820.198(c). Complaints received from January 1, 2002, through January 10, 2005, revealed the most common complaint codes as follows:

 

Class code - 801: Laser not firing,

 

Class code T 833: Translator malfunction,

 

Class code - 802A: Loss of tracking, and

 

Class code - 802B: Not able to track

 

Complaint records associated with these complaint class codes are not adequately reviewed, evaluated, and investigated to determine the root-cause of the system and/or sub-assembly component malfunction (FDA 483, Item #2).

 

Specific complaints reviewed during the inspection revealed the following:

 

a . Complaint Record RS030392 received on April 14, 2003, involving the LADARVision® 4000 Beta, lot number L4B1023S references the laser stopped firing during surgery at 92% complete. The Field Service Engineer (FSE) found arcing in the laser chassis assembly. The FSE adjusted components to prevent future arcing. The complaint record does not document and confirm that an investigation was conducted to determine the root cause of the reported problem. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

 

b. Complaint Record RS041106 received on August 23, 2004, involving LADARVision® 4000 Beta, lot number L4B1023S references the laser not firing. An FSE replaced the laser control electronics that failed. The replaced component was evaluated and verified the failure was caused by a broken connector. The record does not document and confirm that an investigation was conducted to determine the root cause of the broken connector. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

 

c. Complaint Record RS041047 received on August 11, 2004, involving a refurbished LADARVision® 4000 Beta, lot number L4B1090S referencing noise from the laser with a system failed error message. A similar complaint, RS030392 referenced a malfunctioning translator, which was replaced because of faulty/defective bearings. The complaint was classified as complaint class 823- Noise Coming from system. The complaint was more appropriately determined a translator malfunction, which is complaint class 833. The malfunction causes the laser to stop operating or firing resulting in surgery being terminated, causing under correction, which is not considered by your firm to be an injury.

 

d. Complaint Record RS030539 received on May 16, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S referencing loss of tracking during surgery. Surgery was stopped at 57% complete. The FSE balanced the infrared pulse and changed the DSP gains. The record does not document an investigation that was conducted to determine the root-cause of the report to conduct an investigation into the reported malfunction.

 

e. Complaint Record RS031262 received on November 14, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S references a laser unable to track. The FSE confirmed the failure mode and replaced the zoom motor. The Manufacturing Engineer (ME) confirmed that the motor performed erratically when operating under a torque and will not reverse direction when prompted by software. A similar complaint FS030539 (noted above) does not document that an investigation was conducted to determine the root cause for the zoom motor failure or the justification for not conducting an investigation into the malfunction.

 

3. Failure to promptly review, evaluate, and investigate any complaint that represents an event which must be reported to FDA under 21 CFR part 803 by a designated individual(s) and shall be maintained in a separate portion of the complaint files otherwise clearly identified as required by 21 CFR 820.198(d) and 803..50(b)(2).. (FDA 483, Item #3). Complaint .Record RS041447 received on November 5, 2004, (MDR 1061857-2004-00011) involving the LADARVision® 4000, lot number L4N1636S referenced the report of a poor clinical outcome. The primary custom-cornea, lasik procedure conducted on June 4, 2004, resulted in a two line loss of Best Corrected Visual Acuity (BCVA), 20/20 at pre-op and 20/30 at the four month post-op visit. A retreatment was conducted on October 29, 2004, resulting in an additional one line loss of BCVA, which was 20/30 at four months after post-op and 20/40 at one week after the retreatment post-op visit. No review, evaluation, and investigation were conducted of the primary custom-cornea lasik procedure on June 4, 2004. The retreatment procedure was reviewed, evaluated, and investigated, which is not covered under the system's labeling including the collection of data such as Operative Summary, LadarWave printouts, and Operative Reports. The complaint was closed December 13, 2004. No review, evaluation or investigation was conducted of the primary custom-cornea, lasik procedure which occurred on June 4, 2004.

 

4. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product as required by 21 CFR 820.90(b)(1). (FDA 483, Item #4). Your own procedures, specifically, SOP 7501-00.38, Field Returns, and SOP 7003-0909, Evaluation of Non-Conforming Parts Returned from Field Service, are not followed:

 

a. Complaint Record RS040448 - Per the referenced SOPs all parts replaced in the field are to be returned for evaluation. An evaluation of malfunctioning translators was not conducted as required and the service activity was considered routine maintenance instead of being assessed as a complaint.

 

b. Complaint Record RS040031 - Per the referenced SOPs gas filters were not returned for evaluation and an evaluation was not performed. This report was evaluated by Product Safety (PS) and classified as a "Malfunction". Personnel experienced headache, dry tight throat, and nausea resulting in an emergency room (ER) visit.

 

c. Complaint Record RS031155 - A FSE found a lead washer was unevenly crimped, which he replaced. The part was not returned and an evaluation was not performed. A MDR was evaluated by your PS team and classified as "Other" without explanation. Personnel experienced vomiting and nausea resulting in an ER visit.

 

The above-stated inspection also revealed that your device is misbranded under section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information required by or under section 519 respecting the device. Specifically, your firm failed to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any sources, that reasonably suggests that a device marketed by the manufacturer has caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

 

The following complaints referencing serious injuries where not submitted within 30 days to FDA as required:

 a. Complaint Record RS041329 b. Complaint Record RS030632

Your firm also failed to investigate adverse event reports and to evaluate the cause of the reported event as required by 21 CFR 803.50(b)(2). The following adverse event reports have not been adequately investigated as required:

 a. Complaint Record RS030392 b. Complaint Record RS041106 c. Complaint Record RS041047 d. Complaint Record RS031262 e. Complaint Record RS030355 f.. Complaint Record RS031146 g. Complaint Record RS030632 h. Complaint Record RS031257

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

 

We have reviewed your response, dated February 3, 2005. We acknowledge that you have proposed to improve your complaint handling procedure. We would appreciate receiving the periodic reports that you have promised. Nevertheless, your response to the violations discussed above is inadequate because our review of the data shows that reviews, evaluations, and corrective actions were not fully assessed. Also your own procedures were not followed and misinterpretations were made as to the status of complaints that were reported and the conclusions that were drawn, which affected the corrective actions that were required. You should address each and every observation when responding to this letter. Your response has been made part of the Florida District file.

 

Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

 

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.

Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.

Sincerely,

/S/

Emma R . Singleton

Director, Florida District

Living With LASIK

(Below is a transcript of "Living with Lasik--Part Three", which aired on September 27, 2005.)

SOURCE

Anchor One: If you're considering having laser eye surgery -- or if you're one of the thousands of people who've had the procedure and aren't satisfied with the results --- tonight's FOX Focus may be of particular concern to you.

Anchor Two: Last December, we detailed a series of disturbing complaints being made about one of the most prominent lasers currently in use in the U.S. The Food and Drug Administration has now cited the company that makes it with numerous violations, prompting critics to call this machine unsafe. It's a laser you can find in surgical centers throughout the Chicago-area, and tonight our Mark Saxenmeyer is here with an exclusive follow-up. Mark?

Mark on set: Millions of people worldwide are "Living with Lasik" and the majority are quite happy with the results. Yet surgical industry analysts estimate as many as 250,000 Americans now claim to be suffering from some kind of visual complication as a result of it. Determining what exactly went wrong is sometimes difficult--and often impossible to prove. But tonight we focus in on one potential cause--a laser and a company that are now the target of multiple lawsuits and an on-going FDA investigation.

(taped presentation begins)

Voice of laser eye surgeon to a patient: Lie down, head up to the head of the bed

It's a surgery which enables many to throw away their glasses and contacts for good.

Surgeon to patient: The sound you hear is the sound of the laser

A flap is cut open across the eye and a carefully-programmed laser begins vaporizing tissue to correct vision complications.

Surgeon to patient: Just keep looking right there! Beautiful!

It's a two and a half billion dollar a year industry.

Surgeon to patient: Allright you did great!

But sometimes there are horror stories.

Terri Warner: You could hear it powering up. And the red light came on there were like two to four snaps and then there was a hiss, like a small hiss and then there was total silence. There was silence in the whole room.

In July 2004, Terri warner of Savannah, Georgia had laser eye surgery, on a machine like this, the Ladarvision 4000.

Terri Warner: I was told it was of the highest degree of professional machinery that you could get.

But just moments after the laser began firing into her right eye, she says her eye surgeon and an assistant began speaking in hushed, worried tones.

Terri Warner: She asked him to re-boot and he said I've already done that. There were more whispers and she said we're just going to put the flap down and try to figure out what went wrong.

Several days later Terri was asked to return to re-do the surgery on her right eye, and this time, laser her left as well. A follow-up evaluation revealed excellent vision results with the left, but serious problems with the right.

Terri talking with her daughter: I really can't see.

There were inexplicable blisters on her cornea, she says, and despite several additional surgeries to try to fix her right eye....

Terri Warner: As it is now i can't drive my car, I can't, I'm kinda housebound.

There are only half a dozen laser vision correction systems currently in use in the United States. The one used on Terri, the Ladarvision, is made and marketed by Alcon--a Texas-based international pharmaceutical company, and the second largest provider of laser systems in the U.S..

Randy Moore: We believe that the laser did not operate as it was programmed to.

Attorney Randy Moore is suing Alcon on behalf of a different patient, a Dallas woman who claims a Ladarvision laser malfunctioned during her April 2001 surgery.

Randy Moore: We think the laser did not have enough voltage, did not have enough strength to take away the right amount of tissue.

In court documents Alcon denies its laser was defective. Yet Moore says his client, an ophthalmologist herself, is suffering from some of the most common lasik-related side effects:

Randy Moore: Visual distortions, ghosting, halos and starbursts. She describes it as looking through a dirty window.

In fact, many Lasik patients who describe similar problems say they can find nothing--be it glasses or contacts or medications-- to reverse the damage.

Randy Moore: You're permanently impaired for the rest of your life.

Alcon is facing other suits as well. This Maryland eye surgeon claims the Ladarvision laser she used in her practice began to experience "erratic machine performance, discrepancies (and) malfunctions" which resulted in patients suffering "severe visual problems". Alcon has filed a motion to dismiss this case.

The Washington State man who filed this suit, claiming that his vision has also been destroyed, settled out of court with Alcon for 90 thousand dollars just days ago. He alleged that Alcon failed to "advise medical professionals of potential problems with the Ladarvision system. Under the terms of the settlement, however, Alcon neither admits nor denies any liability.

According to its web site, Alcon's lasers are currently being used by dozens of eye surgeons throughout northern Illinois and northwest Indiana. Yet when fox news chicago contacted nearly 20 centers to find out just how satisfied they are with their lasers, and with Alcon, every single one of them declined to be interviewed for this report.

Randy Moore: If they've operated on patients and they've gotten bad results, publicizing the bad result may result in litigation for the physician.

Legal action aside, the Food and Drug Administration is now turning up the heat on Alcon as well, issuing this warning letter which cities Alcon with "failure to review and evaluate all complaints" involving its Ladarvision lasers--violations that may be "symptomatic of serious problems with your firm's manufacturing and quality assurance."

Terri warner talking to her daughter: This one's good.

Yet Terri Warner says it's not good enough.

Terri Warner: Some things are being hidden about this machine and the truth is not coming out.

Alcon finally notified the FDA about the serious injury to Terri Warner's eye 10 months after her surgery. By law, the company is supposed to do it in 30 days.

Terri Warner tucking in her grandson: 'Night Liam.

These days, Terri says she spends much of her time seeking out second opinions, trying to find a way to get her vision back.

Terri Warner: I'd like to see my grandson's face clearly-- just little things that you miss, you know...

Texas Woman Sues Maker of LADARVision

Victim says eyes were injured by Alcon Laser System

 

Dallas, TX (PRWEB) February 4, 2005 -- A Lubbock County, Texas woman is suing the Fort Worth maker of a laser system used by doctors to perform LASIK eye surgery. According to the lawsuit, Sandra Brown v. Alcon Manufacturing, L.T.D. and Alcon Laboratories, Inc., the LADARVision laser is defective (Case #236-209603-05 District Court Tarrant County Texas 236th Judicial District). The lawsuit accuses Alcon of ignoring warnings that may have prevented additional injuries.

 

A surgeon performed LASIK surgery on Dr. Brown, a fellow ophthalmologist, in April 2001, using the LADARVision laser. During the surgery, the laser performed erratically and removed too little tissue in an asymmetrical pattern from Dr. Brown’s eyes. As a result, she sustained permanent damage to her eyes resulting in limited vision. Unfortunately for Dr. Brown, at this time, her vision cannot be repaired by medical or surgical interventions.  

“I specifically waited for the LADARVision laser machine before having my surgery, and the wait cost me my vision,” says Dr. Brown. “I now have to live with damaged vision because of a defect in Alcon's laser. When I started looking into my problem, I realized that I was not alone and many other people have likewise been hurt by this same problem.”  

While horror stories associated with laser vision correction are not new, recent disturbing news about the Alcon LADARVision laser may cause victims to consider whether harm to their eyes was caused by the laser and not doctors and medical staff.  

“In the past, poor surgeries were usually blamed on the surgeon,” says attorney Joel Fineberg, who represents Dr. Brown. “There is now mounting evidence that the Alcon LADARVision laser is at the heart of many of these problems.”  

Surgeons throughout the country are questioning the effectiveness of the laser. In addition, an article authored by an Alcon consultant in the April 2003 issue of Opthalmology, reveals that patients treated with the LADARVision laser are twice as likely to need follow-up surgery. According to an investigative report in the London Times the rate of required retreatment might be even higher.  

“Patients go in expecting to come out with clearer vision, and many times they come out with permanent damage,” says Mr. Fineberg. “What we have here is a company that has decided to ignore serious concerns, raised by a physician, about the safety of their product.”  

To speak with Joel Fineberg about problems associated with Alcon’s LADARVision, contact Joel Fineberg at (214)219-8828 or Mike Androvett at (800)559-4534.

ALCON Malfunctions

01/09/2006

SOURCE

ALCON-ORLANDO TECHNOLOGY DRIVE LADARVISION 4000 OPTHALMIC EXCIMER LASER SYSTEM  Catalog Number 8065490084

Device Problem Error message given

 

Event Date 01/09/2006

Event Type Injury

Event Description

A system operator reports that during lasik surgery, the laser stopped firing at 88. 8% completion and could not be completed within the same session. Patient records provided did not include the pre-operative exam nor bcva measurements and the patient was deployed to iraq prior to the one-month post-operative exam.  Manufacturer Narrative The field service engineer was dispatched to the site to evaluate the system. He confirmed, but could not duplicate the reported issue. He adjusted the thyratron reservoir voltage , optimized the thyratron and conducted testing with over 60,000 shots fired without a mis-fire, pre-fire or uncommanded firing of the laser. System performed within specification at the time of verification. No conclusion can be made.  

01/26/2006 

SOURCE

ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM  

Catalog Number 8065490084

Device Problem

Tracking Event Date 01/26/2006

Event Type Malfunction

Event Description The tracker stopped tracking a patient's eye at 88% during a customer lasik procedure. They were unable to complete the procedure within the same session, however, there was no patient impact/injury associated with this event.  Manufacturer Narrative H. 3. , h6. Evaluation summary: the field service engineer was dispatched to the site to evaluate the device. He was able to duplicate the difficulty with the tracker not tracking. He replaced the galvo box, dsp card, analog box, and completed an alignment of the tracker. Then he completed a system verification. The replaced parts were received in manufacturing, but the evaluation has not been completed.  

02/03/2006 

SOURCE

ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM  

Catalog Number 8065490084

Device Problem Error message given

Event Date 02/03/2006

Event Type Malfunction Event Description A system operator reports an error message, "energy level too low", at approx 20% into a lasik procedure. They performed a gas change, which was unsuccessful, and were unable to complete the procedure within the same session. The pt's procedure was completed later the same day following the field service engineer's visit. There was no pt impact/injury associated with this event.  Manufacturer Narrative Eval summary: the field service engineer (fse) found the gas fill count at 'zero' and the customer was not able to complete any more gas changes. The fse added 2 gas fills from the gas cylinder reserve located on the system and was able to perform system calibration and complete a system verification. The customer was then able to continue with surgery.  

02/09/2006

SOURCE

ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM  

Catalog Number 8065490006

Device Problem Error message given

 

Event Date 02/09/2006

 

Event Type Malfunction

 

Event Description While on-site for a service visit, the field service engineer observed the laser not firing during a surgical procedure and the procedure was not completed within the same session. It s not known wether there was pt impact/injury associated with this event.  Manufacturer Narrative H. 3. , h. 6. : evaluation summary: the field service engineer was at the site on a service call when the event happened. He examined the system and found the thyratron to be faulty. He replaced the laser chassis assembly, replaced the gas bottle and completed a system verification. The returned part was tests and evaluated by manufacturing and a faulty thyratron within the chassis was verified.

The Ladarvision has 97 device reports on the FDA MAUDE database for the period 2004-2006. They are very interesting, particularly all the ones describing lasers shutting down or failing to fire during a procedure, and some unusually large overcorrections.

MDRs filed in the Maude database during December about breakdowns of Ladarvisions.

Go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

From the FDA medwatch database:

SOURCE

"A nurse reports that during lasik surgery, the screen froze. The site shut down the system and re-booted, but was unable to access the remainder of the patient's surgery plan. The procedure could not be completed during the same session. It is not known whether there was a patient impact/injury associated with this event. "

SOURCE

Pt has undergone photorefractive keratectomy (prk) at hosp in a foreign country with a fda approved excimer laser, i. E. The apexplus of the co summit technology.

The purpose of the treatment was correction of myopia which was determined as follows: -7. 3 diopters of myopia (d) and -1. 75 d of astigmatism on the right eye and -6. 8 d of myopia and -1. 5 d of astigmatism on the left eye. The treatment was performed with an ablation zone of 6. 5 mm.

Up to today, at a distance of almost 5 years from the treatment, pt suffers from halos and glare and complains about bad vision at night. In order to collect more info about the device itself, rptr had a look at the documentation put on the internet and downloaded approval p930034 of 10/25/95, the only one that matched the device description and the date. Inside the documents rptr found some criteria which have to be met in order to ensure that the device is suitable for a certain pt.

In the fda letter to summit of 10/20/95 rptr found under restrictions of use that the device is suitable for "moderate nearsightedness (-1. 5 to 7. 0 diopters when concomitant astigmatism is no greater than 1. 5 diopters). ". In addition it is clearly specified as not indicated to correct high myopia (nearsightedness > -7. 0 d). So, as mentioned above, the actual values of myopia and astigmatism exceeded the specified ones. As far as it regards the ablation zone rptr found an indication that the device was approved for a 6. 0 mm ablation area, while during the treatment a 6. 5 mm diameter was used.

So rptr's first question is whether there were amendments to the approval p930034. According to which the corrected values would have been inside an admittable range of new values or was the device used off-label ie outside the indicated limits. Rptr understood from the literature published before procedure date that the problems, pt is reporting, could be due to optical zone edge effects, especially when the pupil is dilated.

According to a survey, performed on pt in 10/99, the ablation was of good homogenity, it was perfectly centered and it had an usuable optical area of 4 mm on the right eye and of 4. 5 mm on the left eye. Thus the dr stated on his report that the reason for the pt's problems has to be the pupillary diameter which is bigger than the treated area (rptr supposes he refers to the usable optical area and not to the abaltion zone).

So rptr's second question is whether fda issued some specifications or amendments to approval which deal with long term risks of debilitating symptoms related to the pupillary diameter, its dynamics and the dimensions of the ablation area.

From the FDA adverse events reporting database:

SOURCE

Quote:

A surgeon reports one patient that was over corrected in his left eye following custom lasik surgery. A review of the patient records provided, indicat at 4-months post -op, this patient was over corrected by 3. 25 diopters and presented with 1. 75 diopters of induced astigmatism. One month later an enhancement was performed on the left eye. Three weeks following the enhancement, the over correction on the left eye had reduced to 1. 25 diopters and the induced astigmatism had resolved, leaving 1. 5 diopters of residual astigmatism. The patient did experience a 1-line decrease in bcva in the left eye during the post-operative period.

And of course, Pre-Market Approval For Alcon's LASERS

SOURCE

P970043/S019

5/1/06

Real-Time LADAR™ 6000 Excimer Laser System

Alcon Laboratories, Inc. Orlando, FL 32826

Approval for changes in the LADARVision® 4000 System including a new configuration of the illumination system, upgrades to the laser computer and operating system, and various other hardware and software changes intended to address compliance with EMI requirements, manage component obsolescence, reduce maintenance requirements, and enhance ergonomic and user interface features. The device, as modified, will be marketed under the trade name LADAR™ 6000 Excimer Laser System.  

P970043/S020

5/1/06

Panel LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System

Alcon Laboratories, Inc. Orlando, FL 32826

Approval for the LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea® laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of hyperopia and hyperopic astigmatism of +0.75 D to less that +5.00 D of sphere with up to -3.00 D of cylinder (which has a magnitude less than or equal to the sphere in minus cylinder convention) and up to +5.00 cycloplegic spherical equivalent at the spectacle plane; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D.  

P970043/S022

5/2/06

Panel LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System

Alcon Laboratories, Inc. Orlando, FL 32826

Approval for the LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea® laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of mixed astigmatism 1.00 D to less than 5.00 D cycloplegic cylinder magnitude at the spectacle plane, which is greater than the sphere magnitude, and the cylinder and sphere have opposite signs; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D.  

P970043/S023

5/1/06

180-Day LADAR™ 6000 Excimer Laser System Alcon Laboratories, Inc. Orlando, FL 32826 Approval to increase the pulse repetition rate of the LADAR™ 6000 Excimer Laser from 60 Hz to 92 Hx.

Lasers or surgeons:  What’s really the cause of high retreatment rates?

 

SOURCE

Satisfied users of Alcon Inc.’s LADARVision excimer laser abound, but other surgeons are convinced retreatments were too frequent after they used the system.  LADARVision detractors cite a study published in the April 2003 edition of Ophthalmology as evidence that they’re right. The study, authored by Peter Hersh, M.D., an Alcon (Forth Worth, Texas) consultant concluded that “patients treated on the LADARVision laser had almost twice the rate of retreatment (18.2%) compared with the Summit Apex Plus laser (9.7%),” which is no longer manufactured. 

See the full story at source.

 

ALCON RECALLS

 

 

ALCON LABORATORIES, INC.

 

LADARVision Excimer Laser System:  CustomCornea software only. Class II. 

 

Reason:  A software error associated with the use of the Measuring Mode (ruler tool).  Vol. 15:9.

 

 

Alcon Recalls Systane Free Eye Drops

 

Friday December 15, 7:21 am ET 
Alcon Recalls Systane Free Liquid Gel Lubricant Eye Drops Due to Mold


FORT WORTH, Texas (AP) -- Eye-care products maker Alcon Laboratories Inc. on Thursday issued a voluntary recall of its Systane Free Liquid Gel lubricant eye drops.
Bottles of the lubricant that were returned to Alcon were found to have mold, although Alcon said developing an infection from the mold is unlikely.

 

Read The Story


 

FDA Posted Alcon Recall Information

 

SOURCE

Medical Device Recalls  Class 2 Recall  AcrySof® Intraocular Lens

Date Recall Initiated: December 14, 2006

Date Posted: February 15, 2007

Recall Number: Z-0431-2007

Product: AcrySof® Intraocular Lens

Code Information: Model MA60AC, serial number 989984.028

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 6201 South Fwy Fort Worth, Texas 76134-2001

Reason For Recall: Intraocular lenses exposed to extreme temperatures while in storage.

Action: The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006. Firm Initiated recall is ongoing.

Quantity in Commerce: one unit 

Distribution: Nationwide

SOURCE

Medical Device Recalls  Class 2 Recall  AcrySof® ReSTOR® Intraocular Lens

Date Recall Initiated: December 14, 2006

Date Posted: February 15, 2007

Recall Number: Z-0430-2007

Product: AcrySof® ReSTOR®  Intraocular Lens

Code Information: Model MN60D3, Serial numbers: 940376.028; 945173.084; 945533.043; 945174.053; 944089.027; 942202.069; 940407.058; 940407.059; 942210.016; and 945537.073  

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 6201 South Fwy Fort Worth, Texas 76134-2001

Reason For Recall: Intraocular lenses exposed to extreme temperatures while in storage.

Action: The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006. Firm Initiated recall is ongoing.

Quantity in Commerce: 10 units

Distribution: Nationwide

SOURCE

Medical Device Recalls  Class 2 Recall  AcrySof® ReSTOR® Intraocular Lens

Date Recall Initiated: December 14, 2006

Date Posted: February 15, 2007

Recall Number: Z-0429-2007

Product: AcrySof® ReSTOR® Intraocular Lens

Code Information: Model SN60D3, Serial numbers: 968290.039; 934317.012; 934317.013; and 948332.080.

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 6201 South Fwy Fort Worth, Texas 76134-2001

Reason For Recall: Intraocular lenses exposed to extreme temperatures while in storage.

Action: The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006. Firm Initiated recall is ongoing.

Quantity in Commerce: 4 units

Distribution: Nationwide

SOURCE

Medical Device Recalls  Class 2 Recall  Custom-Pak® Surgical Packs

Date Recall Initiated: December 22, 2006

Date Posted: March 01, 2007

Recall Number: Z-0564-2007

Product: Alcon Custom-Pak®, part #11148-02, containing BD Beaver? Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Code Information: Lot #632178H, 634400H and 642229H

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 9965 Buffalo Speedway Houston, Texas 77054-1309

Reason For Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

Action: Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. Firm Initiated recall is ongoing.

Quantity in Commerce: 65 custom surgical packs.

Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

SOURCE

Medical Device Recalls  Class 2 Recall  Custom-Pak® Surgical Packs

Date Recall Initiated: December 22, 2006

Date Posted: March 01, 2007

Recall Number: Z-0563-2007

Product: Alcon Custom-Pak®, part #6515-51, containing BD Beaver? Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Code Information: Lot #633317H, 645074H, and 629784H

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 9965 Buffalo Speedway Houston, Texas 77054-1309

Reason For Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

Action: Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. Firm Initiated recall is ongoing.

Quantity in Commerce: 30 custom surgical packs.

Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

SOURCE

Medical Device Recalls  Class 2 Recall  Custom-Pak® Surgical Packs

Date Recall Initiated: December 22, 2006

Date Posted: March 01, 2007

Recall Number: Z-0562-2007

Product: Alcon Custom-Pak®, part #4917-54, containing BD Beaver? Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Code Information: Lot #629460H, 631237H, 632356H and 642330H.

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 9965 Buffalo Speedway Houston, Texas 77054-1309

Reason For Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

Action: Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. Firm Initiated recall is ongoing.

Quantity in Commerce: 80 custom surgical packs.

Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

SOURCE

Medical Device Recalls Class 2 Recall Custom-Pak® Surgical Packs 

Date Recall Initiated: December 22, 2006

Date Posted: March 01, 2007

Recall Number: Z-0561-2007

Product: Alcon Custom-Pak?, part #2638-17, containing BD Beaver? Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Code Information: Lot #627618H and 636380H

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 9965 Buffalo Speedway Houston, Texas 77054-1309

Reason For Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

Action: Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. Firm Initiated recall is ongoing.

Quantity in Commerce: 27 custom surgical packs.

Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

SOURCE

Medical Device Recalls  Class 2 Recall  Custom-Pak® Surgical Packs

Date Recall Initiated: December 22, 2006

Date Posted: March 01, 2007

Recall Number: Z-0560-2007

Product: Alcon Custom-Pak?, part #10975-02, containing BD Beaver? Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Code Information: Lot #649244H

Recalling Firm/Manufacturer: Alcon Laboratories, Inc 9965 Buffalo Speedway Houston, Texas 77054-1309

Reason For Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

Action: Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. Firm Initiated recall is ongoing.

Quantity in Commerce: 4 custom surgical packs.

Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

SOURCE

Medical Device Recalls   Class 2 Recall  Alcon Custom Pak

Date Recall Initiated: September 02, 2005

Date Posted: September 21, 2005

Recall Number: Z-1575-05

Product: Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm's Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

Code Information: Lot numbers: 520522H, 511655H, and 489635H

Recalling Firm/Manufacturer: Alcon Research, Ltd 6201 South Fwy Fort Worth , Texas 76134-2001

Reason For Recall: Unknown residue noted on suface of flap irrigators incorporated into cusom paks.

Action: Firm notified consignee by letter on 9/2/2005. Firm Initiated recall is ongoing.

Quantity in Commerce: 75 units

Distribution: Lake Charles, LA

Effect of beam size on the expected benefit of customized laser refractive surgery

J Refract Surg. 2003 Jan-Feb;19(1):15-23.

Guirao A, Williams DR, MacRae SM

University of Murcia, Murcia, Spain.

PURPOSE: Customized laser surgery attempts to correct higher order aberrations, as well as defocus and astigmatism. The success of such a procedure depends on using a laser beam that is small enough to produce fine ablation profiles needed to correct higher order aberrations.

METHODS: Wave aberrations were obtained from a population of 109 normal eyes and 4 keratoconic eyes using a Shack-Hartmann wavefront sensor. We considered a theoretical customized ablation in each eye, performed with beams of 0.5, 1.0, 1.5, and 2.0 mm in diameter. We then calculated the residual aberrations remaining in the eye for the different beam sizes. Retinal image quality was estimated by means of the modulation transfer function (MTF), computed from the residual aberrations. Fourier analysis was used to study spatial filtering of each beam size.

RESULTS: The laser beam acts like a spatial filter, smoothing the finest features in the ablation profile. The quality of the correction declines steadily when the beam size increases. A beam of 2 mm is capable of correcting defocus and astigmatism. Beam diameters of 1 mm or less may effectively correct aberrations up to fifth order.

CONCLUSION: Large diameter laser beams decrease the ability to correct higher order aberrations. A top-hat laser beam of 1 mm (Gaussian with FWHM of 0.76 mm) is small enough to produce a customized ablation for typical human eyes.

Commercially Approved Wavefront-guided Custom Ablation: Second Year in Review:

The Pupil is a Moving Target: Centration, Repeatability, and Registration

Journal of Refractive Surgery  Vol. 20   No. 5   September/October 2004

Eric Donnenfeld, MD

PURPOSE: To evaluate the ability to accurately center and register wavefront data to provide effective custom wavefront application for vision correction.

METHODS: Centration images were obtained of 40 undilated pupils at 5 different illumination levels using the Alcon LADARWave aberrometer (Alcon Laboratories Inc, Fort Worth, Tex). Pupil position relative to the limbus was determined for all eyes under all levels of illumination. Variability in centration of the pupil was based on difference in magnitude of offset between pupil center and limbal center. Human operators were compared to a computerized limbus recognition system through repeatability testing using 10 different images of one eye of a single patient.

RESULTS: As determined by human operators, the pupil center in undilated pupils shifted a mean of 175 µm between the lowest level and the highest level of illumination (range 34 to 335 µm [standard deviation 84 µm]). Repeatability testing suggests human measurements can accurately position the pupil to within approximately 50 µm using current technology. Computer image processing using limbus recognition software appears equal or superior to manual pupil centration.

CONCLUSIONS: The pupil center can have a significant change in position with changing illumination. Wavefront data must be centered on a fixed eye structure rather than the pupil center to ensure that wavefront data captured in scotopic light are appropriately matched to the pupil in the photopic light used at surgery. The goal is to avoid clinically significant decentration of the wavefront between capture and excimer laser application. [J Refract Surg 2004;20:S593-S596]

AUTHORS: From Ophthalmic Consultants of Long Island, TLC Laser Centers, New York. Dr Donnenfeld is a consultant with Alcon Laboratories Inc.

Correspondence: Eric Donnenfeld, MD, 2000 N Village Ave #402, Rockville Centre, NY 11570. Tel: 516.766.2519; Fax: 516.766.3714.