MAUDE Adverse Event Report: BAUSCH + LOMB INC. ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ETN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of the event could not be conclusively determined, however patient related factors may have caused or contributed to this event.
Event or Problem Description
A surgeon reported that four months post right eye iol (intraocular lens) implantation, the lens was explanted due to the patient experiencing dysphotosia.A new lens of the same model was placed and the patient is currently doing well.

• Brand Name: ENVISTA ENVY TORIC 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 ; 7277246600
• MDR Report Key: 24092584
• Report Number: 0001313525-2026-00005
• Device Sequence Number: 10327999
• Product Code: MFK
• UDI-Device Identifier: 10757770640338
• UDI-Public: (01)10757770640338(17)280331(11)250425(10)3R10404
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: ETN
• Device Catalogue Number: ETNU125+205
• Device Lot Number: 3R10404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Unknown