Z-2552-2020Class II

enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb -

Name: Z-2552-2020 enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb -
Creator: Bausch & Lomb Surgical, Inc.
Published: 2020-06-09
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2020-06-09 / Terminated

FDA source

Bausch & Lomb Surgical, Inc. began a recall of enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the... on 2020-06-09. FDA classified it as Class II and gives the reason as "The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2552-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-09
Posted: 2020-07-10
Terminated: 2021-02-11
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQL Intraocular Lens
Reason for recall: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
FDA root cause: Unknown/Undetermined by firm
Action: On 06/09/2020, BAUSCH and LOMB's Sales Representatives contacted customers by telephone and email. In addition, the firm sent a letter to customers dated, June 17, 2020 and titled, "MEDICAL DEVICE VOLUNTARY PRODUCT RECALL". The letter informs customers about a voluntary recall of one lot of enhanced enVista MX60ET intraocular lenses (IOLs). Customers should quarantine product and return product to the firm. Customers should complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact the firm to obtain a Return Material Authorization Number and arrange for pickup of the identified product. The contact information for Bausch and Lomb Surgical Customer Service is 1-800-338-2020, Customer Service (option 2).
Quantity in commerce: 5
Distribution: U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2552-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2552-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10

Product code HQL

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)