RecallRadar

FDA Device recall Z-1062-2014

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

On 2014-02-26 the FDA classified a Class II 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… by Bausch And Lomb Surgical, citing lens was manufactured with incorrect raw material.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1062-2014
ClassificationClass II
Statusterminated
Initiated2013-10-16
Published2014-02-26
Last updated2026-09-13 11:53 UTC
CompanyBausch And Lomb Surgical
DistributionUS

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.

Reason

Lens was manufactured with incorrect raw material.

Identifiers

code_infoModel Numbers(s): AO60 and MI60L

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1062-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.