FDA Medical Device Recalls (openFDA)
Bausch & Lomb Surgical, Inc.: MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
- Recall number
- Z-0519-2021
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Product
- MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
- Status
- Terminated
- Initiated
- 2020-11-07
- Posted
- not on file
- Terminated
- 2024-07-11
- Reason
- Product may be missing toric axis marks.
- Root cause
- Process change control
- Action
- The firm initiated the recall by letter on 11/07/2020. The letter requested the consignee review their inventory and quarantine all suspect product. It further requested that the consignee complete the acknowledgement form and contact Bausch & Lomb to obtain a Return Material Authorization Number and arrange for pick up of the devices. Those with questions or concerns regarding the process should call 1-800-338-2020.
- Quantity
- 31 devices
- Distribution
- US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
- Lot, serial or model codes
- Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005 3043816006 3043816007 3043816008 3043816009 3043816010 3043816011 3043816012 3043816013 3043816014 3043816015 3043816016 3043816017 3043816018 3043816019 3043816020 3043816023 3043816024 3043816025 3043816026 3043816027 3043816028 3043816029 3043816030 3043816031
- 510(k) numbers
- not on file
- PMA numbers
- ["P910056S036"]
- Product code
- MJP
- Firm FEI
- 1119279
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28