MAUDE Adverse Event Report: BAUSCH + LOMB 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 Impairment (2138); Halo (2227)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgery center reported that following implantation of the intraocular lens (iol), the patient experienced nighttime driving difficulties and halos.The iol was subsequently exchanged for the same model and power.According to the surgeon, the most likely cause of the symptoms was dysphotopsia related to visual disturbances from the iol.
Additional Manufacturer Narrative
The device was returned for evaluation.Inspection showed that the lens had been cut in half, with one haptic attached to each separated lens segment.Due to the condition of the device, further evaluation could not be performed to determine whether the patient experienced halos.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Additional Manufacturer Narrative
Correction b4, included date of submission.

• Brand Name: 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: 24706485
• Report Number: 0001313525-2026-00020
• Device Sequence Number: 21471917
• Product Code: MFK
• UDI-Device Identifier: 10757770637284
• UDI-Public: (01)10757770637284(17)280531(11)250606(10)3R13856
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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): 03/26/2026

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: ENU2150
• Device Lot Number: 3R13856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female