Data Foundry

Medical device recalls 2014

Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended… — Class II medical device recall Z-1062-2014

Terminated recall by Bausch & Lomb Surgical, Inc., reported 2014-02-26, distributed nationwide. Lens was manufactured with incorrect raw material.

Recall numberZ-1062-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBausch & Lomb Surgical, Inc., Clearwater, FL, United States
Recall initiated2013-10-16
Classified2014-02-20
Reported by FDA2014-02-26
Terminated2014-09-17
DistributedNationwide (US)
Countries outside the USES, FR, GB, PT, RU, SE
Model numbersAO60, MI60L

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 for recall

Lens was manufactured with incorrect raw material.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1062-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.