Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorpo

FDA device recall Z-0591-2010 · posted 2010-01-11 · Terminated

Recall details

Recalling firm

Bausch & Lomb Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

HQL

Quantity affected

85 lenses

Distribution

Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.

Date initiated

2009-11-19

Date posted

2010-01-11

Date terminated

2010-07-22

Location

Rochester, NY