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 Eyelite Laser

  • 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 Recall Eyelite Lasersee related information
Date Initiated by FirmApril 09, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall NumberZ-0923-04
Recall Event ID 28883
Product Classification Laser, Ophthalmic - Product Code HQF
ProductOpthalmic Laser, product number 8065-5000-1
Code Information None
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Freeway
Fort Worth TX 76134-2099
For Additional Information ContactC. Gregory Williams
817-551-6813
Manufacturer Reason
for Recall		Product may generate laser light flashback.
FDA Determined
Cause 2		Other
ActionAdditional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004.
Quantity in Commerce62
DistributionNationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.
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.
-
-