Device 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.
Z-2552-2020
Product summary
- Event
- Event 85862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2552-2020
Official wording
Reason: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
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)
Distribution pattern: U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Derived failure modes
-
Unknown
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.