Class 2 Device Recall SoFlex SE Foldable Intraocular Lens

• Date Initiated by Firm: November 19, 2009
• Date Posted: January 11, 2010
• Recall Status: Terminated on July 22, 2010
• Recall Number: Z-0591-2010
• Recall Event ID: 53949
• PMA Number: P910061
• Product Classification: Intraocular Lens - Product Code HQL
• Product: 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.
• Code Information: Model Number: LI61SE, Lot Number: 4916928.
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc; 1400 North Goodman Street; Rochester NY 14609-3547
• For Additional Information Contact: David Thomas; 585-338-6000
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 85 lenses
• Distribution: Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.
• Total Product Life Cycle: TPLC Device Report

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.

• PMA Database: PMAs with Product Code = HQL