Bausch & Lomb Surgical, Inc.: 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.

Recall number

Z-1062-2014

Recalling firm

Bausch & Lomb Surgical, Inc.

Product

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.

Status

Terminated

Initiated

2013-10-16

Posted

2014-02-20

Terminated

2014-09-17

Reason

Lens was manufactured with incorrect raw material.

Root cause

Nonconforming Material/Component

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.

Quantity

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.

Lot, serial or model codes

Model Numbers(s): AO60 and MI60L

510(k) numbers

not on file

PMA numbers

["P060022"]

Product code

HQL

Firm FEI

1119279

Firm city

Clearwater

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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