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.
|