Z-0519-2021Class II

MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET -

Name: Z-0519-2021 MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET -
Creator: Bausch & Lomb Surgical, Inc.
Published: 2020-11-07
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2020-11-07 / Terminated

FDA source

Bausch & Lomb Surgical, Inc. began a recall of MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag on 2020-11-07. FDA classified it as Class II and gives the reason as "Product may be missing toric axis marks". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0519-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-07
Posted: 2020-12-02
Terminated: 2024-07-11
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: MJP Lens, Intraocular, Toric Optics
Reason for recall: Product may be missing toric axis marks.
FDA 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 in commerce: 31 devices
Distribution: US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0519-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0519-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-02

Product code MJP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)