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.
Reported: February 26, 2014 Initiated: October 16, 2013 #Z-1062-2014
Product Description
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.
Details
- Recalling Firm
- Bausch & Lomb Surgical, Inc.
- Units Affected
- 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.
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 336 IOLs (283 IOLs in the US, 53 IOLs outside the US).
Why was this product recalled? ▼
Lens was manufactured with incorrect raw material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1062-2014.
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