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U.S. Department of Health and Human Services

Class 2 Device Recall Eyelite Laser

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  Class 2 Device Recall Eyelite Laser see related information
Date Initiated by Firm April 09, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-0923-04
Recall Event ID 28883
Product Classification Laser, Ophthalmic - Product Code HQF
Product Opthalmic 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 Contact C. Gregory Williams
817-551-6813
Manufacturer Reason
for Recall		 Product may generate laser light flashback.
FDA Determined
Cause 2		 Other
Action Additional 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 Commerce 62
Distribution Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.
Total Product Life Cycle TPLC 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.
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