Z-1062-2014Class II

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

Name: Z-1062-2014 Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular...
Creator: Bausch & Lomb Surgical, Inc.
Published: 2013-10-16
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2013-10-16 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Surgical, Inc. began a recall of 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... on 2013-10-16. FDA classified it as Class II and gives the reason as "Lens was manufactured with incorrect raw material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1062-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-16
Posted: 2014-02-20
Terminated: 2014-09-17
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQL Intraocular Lens
Reason for recall: Lens was manufactured with incorrect raw material.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Model Numbers(s): AO60 and MI60L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1062-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1062-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)