MAUDE Adverse Event Report: BAUSCH + LOMB IOL-ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ENU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrected b3.Additional information b5, b7, g3.
Event or Problem Description
Received additional information, the patients prognosis is subjective visual disturbance.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol), the patient experienced blurred vision and visual disturbances.The lens was explanted and replaced with a different model iol one month post original implant.Additional information was requested, but not received.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation revealed that half the lens had been cut and a small portion of the optic was stuck to the surface of the lens with one haptic attached.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The 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 information provided, a root cause of this event could not be determined.

• Brand Name: IOL-ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 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: 25253865
• Report Number: 0001313525-2026-00057
• Device Sequence Number: 17500719
• Product Code: MFK
• UDI-Device Identifier: 10757770637291
• UDI-Public: (01)10757770637291(17)281231(11)260108(10)3R35445
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P210005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: ENU
• Device Catalogue Number: ENU2200
• Device Lot Number: 3R35445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown