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 Disturbances (2140); Halo (2227); Photophobia (4801); Diplopia/Double Vision (4802)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two weeks after implantation of an intraocular lens (iol) in the patient's right eye (od), the patient complained of visual disturbances including doubling and shadowing of letters and lights, light related glare and halos, and ghosting of objects such as cars.Approximately three months after symptom onset, the iol was exchanged for a different model.In the surgeon¿s opinion, the most likely cause of event was visual disturbance with the multifocal iol.The patient has since recovered.This is the report for the right eye (od).Left eye (os) reference: 0001313525-2026-00087.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

• Brand Name: ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25612500
• Report Number: 0001313525-2026-00088
• Device Sequence Number: 15945585
• Product Code: MFK
• UDI-Device Identifier: 10757770636485
• UDI-Public: (01)10757770636485(17)281031(11)251121(10)3R31653
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: ENU2000
• Device Lot Number: 3R31653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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: 57 YR
• Patient Sex: Unknown