Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the

FDA device recall Z-1062-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Bausch & Lomb Surgical, Inc.

Reason for recall

Lens was manufactured with incorrect raw material.

Action taken

The firm, Bausch + Lomb, telephoned and sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 17, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Determine the disposition of the lenses; 2) Complete and provide the enclosed acknowledgement form to the sales respresentatives collecting the lenses, and 3) Return all unused products. If you have any questions, please contact Bausch + Lomb at (800) 338-2020.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HQL

Quantity affected

336 IOLs (283 IOLs in the US, 53 IOLs outside the US)

Distribution

Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.

Date initiated

2013-10-16

Date posted

2014-02-20

Date terminated

2014-09-17

Location

Clearwater, FL