Recall Z-1735-2009 ยท LPN Accessories, Soft Lens Products
Bausch & Lomb Inc
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
| Date | Aug 13, 2009 (initiated Jun 30, 2009) |
| Status | Terminated |
| Reason | The product failed to meet one of the shelf life specifications at the end of the expiry period. |
| Root cause | Other |
| Action | Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notice dated June 26, 2009. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, Indianapolis, IN. A Business Reply Card was included to be returned to Bausch & Lomb via US mail. A prepaid UPS Packing Slip was also provided to return the affected product. For further questions, contact Bausch & Lomb Customer Resource Center at 1-800-828-9030. |
| Quantity | 56,000 bottles |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983836 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION Polymer Technology Div. Wilmington Partners, L.P., Feb 11, 1999 |