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IntraLase Product Recalls PDF Print E-mail
Monday, 14 November 2005 19:00

IntraLase Product Recalls

http://www.fda.gov/bbs/topics/enforce/2003/ENF00810.html

PRODUCT
Intralase FS Laser System. Laser Keratome. Recall # Z-1124-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Intralase Corp., Irvine, CA, by letters on July 15, 2003. Firm initiated recall is ongoing.
REASON
Gantry moves toward patient when 'Home' button is used after procedure.
VOLUME OF PRODUCT IN COMMERCE
70.
DISTRIBUTION
Nationwide and Japan.

http://www.fda.gov/bbs/topics/enforce/2002/ENF00767.html

PRODUCT
INTRALASE FS 600 C Laser System (Model 1), Laser Keratome. Recall # Z-0147-3.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
IntraLase Corporation, Irvine, CA, by letter dated October 2, 2002. FDA initiated recall is ongoing.
REASON
Design defect, wire breakage, causes laser failure, interrupting surgery.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide and Mexico.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

Type in "Intralase" for the brand name to pull up MDRs filed on Intralase. The product code is GEX but you will get other reports not related to Intralase.