Recall Z-1062-2014— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2013-10-16, terminated 2014-09-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-16
- Terminated
- 2014-09-17
- Firm location
- Clearwater, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.