| | Class 2 Device Recall Bausch & Lomb |  |
| Date Initiated by Firm | February 27, 2004 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on May 03, 2012 |
| Recall Number | Z-1093-04 |
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| 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 |
| FEI Number |
1119279
|
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 |
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Manufacturer Reason
for Recall | Lens may be labeled with incorrect diopter size. |
|---|
FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 36 |
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| Distribution | Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH. |
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| 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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