Z-0628-2019Class II

enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual...

Name: Z-0628-2019 enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual...
Creator: Bausch & Lomb Surgical, Inc.
Published: 2018-11-05
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2018-11-05 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Surgical, Inc. began a recall of enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom... on 2018-11-05. FDA classified it as Class II and gives the reason as "Cosmetic imperfections on the surface of some lenses". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0628-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-05
Posted: 2018-12-18
Terminated: 2019-11-04
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQL Intraocular Lens
Reason for recall: Cosmetic imperfections on the surface of some lenses.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On Nov 5, 2018 Bausch & Lomb sent letters to all their consignees, requesting the following; 1. Review and quarantine your inventory of all the impacted lots for this recall. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact B&L to obtain a return material authorization number and arrange for a pick up of the identified product. Contact 800-338-2020 option 2. If you have any questions, contact the Quality Manager at 727-724-6695.
Quantity in commerce: 70,440 units
Distribution: US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0628-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

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)