Recall Z-0591-2010 ยท HQL Intraocular Lens
Bausch & Lomb Inc
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
| Date | Jan 11, 2010 (initiated Nov 19, 2009) |
| Status | Terminated |
| Reason | Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens. |
| Root cause | Other |
| Action | Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009. Titled "Urgent - Medical Device Recall", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm. For further information, contact Bausch & Lomb at 1-585-338-6612. |
| Quantity | 85 lenses |
| Distribution | Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.