Recall Z-2552-2020— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2020-06-09, terminated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.. Reason: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-09
- Terminated
- 2021-02-11
- Firm location
- Clearwater, FL, United States
Product description
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Reason for recall
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Data sourced from openFDA. This site is unofficial and independent of the FDA.