FDA Device recall Z-2552-2020
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the…
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the… by Bausch And Lomb Surgical, citing the toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2552-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-09 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | US |
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.
Identifiers
| code_info | Model number: MX60ET, Catalog number: MXUET Lot numbers: Lot Number 3043212 Serial Numbers: 3043212002 (UDI (0…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Bausch And Lomb Surgical
- Akreos, SKU: AO60P0300
FDA Device · Class III · 2025-09-03 · Bausch And Lomb Surgical - Intraocular Lens. enVista Envy IOL, All models starting with EN
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - Intraocular lens. enVista Monofocal IOL, All models starting with EE
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
FDA Device · Class II · 2020-12-09 · Bausch And Lomb Surgical - enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul…
FDA Device · Class II · 2018-12-26 · Bausch And Lomb Surgical
All Bausch And Lomb Surgical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2020%22
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