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Terminated

Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

FDA Recall Z-1062-2014 · Posted 2014-02-20

Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2013-10-16
Date Terminated2014-09-17
Product Quantity336 IOLs (283 IOLs in the US, 53 IOLs outside the US)

Reason for Recall

Lens was manufactured with incorrect raw material.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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