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…
- FDA Device
- Class II
- terminated
- Published 2014-02-26
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1062-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-16 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | US |
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_info | Model 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
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