FDA Device recall Z-0628-2019
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul… by Bausch And Lomb Surgical, citing cosmetic imperfections on the surface of some lenses.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0628-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-05 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | US |
Product
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
Reason
Cosmetic imperfections on the surface of some lenses.
Identifiers
| code_info | Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0…Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0600, MXUE0700, MXUE0800, MXUE0900, MXUE1000, MXUE1050, MXUE1100, MXUE1150, MXUE1200, MXUE1250, MXUE1300, MXUE1350, MXUE1400, MXUE1450, MXUE1500, MXUE1550, MXUE1600, MXUE1650, MXUE1700, MXUE1750, MXUE1800, MXUE1850, MXUE1900, MXUE1950, MXUE2000, MXUE2050, MXUE2100, MXUE2150, MXUE2200, MXUE2250, MXUE2300, MXUE2350, MXUE2400, MXUE2450, MXUE2500, MXUE2550, MXUE2600, MXUE2650, MXUE2700, MXUE2750, MXUE2800, MXUE2850, MXUE2900, MXUE2950, MXUE3000, MXUE3100, MXUE3200, MXUE3300, and MXUE3400. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0628-2019%22
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