SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
FDA device recall Z-1093-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Reason for recall
- Lens may be labeled with incorrect diopter size.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 36
- Distribution
- Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
- Date initiated
- 2004-02-27
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-03
- Location
- Clearwater, FL
Monitor recalls programmatically
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