enVista one-piece hydrophobic acrylic toric intraocular recall
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular…
Why was enVista one-piece hydrophobic acrylic toric intraocular recalled?
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular…
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Quantity
- 5
- Distribution
- U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)