CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
Bausch & Lomb Akreos AO Micro Incision Lens The Akreos IOL recalled
Bausch & Lomb Surgical is recalling Bausch & Lomb Akreos AO Micro Incision Lens The Akreos IOL intended for primary, distributed nationwide in the US. The recall was initiated on 16 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1062-2014
- FDA event ID
- 67283
- Recalling firm
- Bausch & Lomb Surgical, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2013
- FDA classified
- 20 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 16 Oct 2013 | Recall initiated by company | |
| 20 Feb 2014 | Classified by FDA | +127 days |
| 26 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lens was manufactured with incorrect raw material.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Questions about this recall
Why was it recalled?
Lens was manufactured with incorrect raw material.
Which lots are affected?
Model Numbers(s): AO60 and MI60L
Where was it sold?
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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