Recall Z-2154-2015— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2015-05-26, terminated 2016-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are 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: Haptics breaking during lens loading and insertion..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-26
- Terminated
- 2016-08-25
- Firm location
- Clearwater, FL, United States
Product description
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are 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
Haptics breaking during lens loading and insertion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.