SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
- Company
- Bausch & Lomb Surgical, Inc.
- Recall Initiated
- February 27, 2004
- Posted
- July 20, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-1093-04
- Quantity
- 36
- Firm Location
- Clearwater, FL
Reason for Recall
Lens may be labeled with incorrect diopter size.
Distribution
Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
Lot / Code Info
8XRJ
Root Cause
Other
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.
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