MAUDE Adverse Event Report: Bausch + Lomb Inc. enVista Envy hydrophobic acrylic intraocular lens; Lens, multifocal intraocular

Model Number	EN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately four months post intraocular lens (iol) implantation in the right eye, the lens was explanted due to the patient experiencing glares and halos.A back up lens of a different model was placed.
Additional Manufacturer Narrative
Device was discarded and is not available for evaluation.The device history review (dhr), lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.

• Brand Name: enVista Envy hydrophobic acrylic intraocular lens
• Common Device Name: Lens, multifocal intraocular
• Manufacturer (Section D): Bausch + Lomb Inc.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): Bausch + Lomb, Inc; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50944761
• Report Number: 0001313525-2026-00153
• Device Sequence Number: 13149637
• Product Code: MFK
• UDI-Device Identifier: 10757770637307
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EN
• Device Catalogue Number: ENU2250
• Device Lot Number: 3S07226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown