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Class 2 Device Recall Bausch & Lomb |
 |
| Date Initiated by Firm |
February 27, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on May 03, 2012 |
| Recall Number |
Z-1093-04 |
| Recall Event ID |
29055 |
| Product Classification |
Intraocular Lens - Product Code HQL
|
| Product |
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. |
| Code Information |
8XRJ |
Recalling Firm/
Manufacturer |
Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
|
| For Additional Information Contact |
Mary Adams
909-971-5303
|
Manufacturer Reason
for Recall |
Lens may be labeled with incorrect diopter size.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees. |
| Quantity in Commerce |
36 |
| Distribution |
Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH. |
| Total Product Life Cycle |
TPLC Device Report
|
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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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