Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 15, 2003
Date PostedAugust 12, 2003
Recall Status1 Terminated 3 on December 02, 2004
Recall NumberZ-1124-03
Recall Event ID 26826
510(K)NumberK001211 K002890 K013941 K993153 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
ProductIntralase FS Laser System. Laser Keratome
Code Information All codes
Recalling Firm/
Manufacturer		 Intralase Corp
3 Morgan
Irvine CA 926181916
For Additional Information ContactCharline Gauthier
949-859-5230 Ext. 244
Manufacturer Reason
for Recall		Gantry moves toward patient when 'Home' button is used after procedure.
FDA Determined
Cause 2		Other
ActionFirm sent Safety Alert letters to customers on July 15, 2003 by registered mail instructing not to use the HOME button, including a 'Do Not Use' sticker for the machine and an addendum to the Operations Manual.
Quantity in Commerce70
DistributionNationwide and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
-
-