Z-2552-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- June 9, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Code Information
Model number: MX60ET, Catalog number: MXUET Lot numbers: Lot Number 3043212 Serial Numbers: 3043212002 (UDI (01)10757770555199(17)230131(21)3043212002); 3043212005 (UDI (01)10757770555199(17)230131(21)3043212005); 3043212006 (UDI (01)10757770555199(17)230131(21)3043212006); 3043212007 (UDI (01)10757770555199(17)230131(21)3043212007); 3043212008 (UDI (01)10757770555199(17)230131(21)3043212008)