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

Model Number	EN
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Visual Disturbances (2140); Insufficient Information (4580)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that approximately two months after implantation of an intraocular lens (iol), the surgeon observed that the intraocular lens appeared cloudy.The surgeon initially suspected posterior capsule opacification (pco) and began performing a yag laser posterior capsulotomy.After the first yag laser shot, the surgeon observed that the haze originated from within the iol optic rather than the posterior capsule and the yag procedure was aborted.An iol exchange was subsequently performed.During removal, the posterior capsular opening created by the initial yag shot enlarged as the surgeon attempted to rotate the temporal haptic, which was stuck in the capsular fornix.Because the haptic could not be safely freed, it was cut and a different model iol was then placed in the sulcus with reverse optic capture.In the surgeon¿s opinion, the most likely cause of the event is a defect in the original iol.
Additional Manufacturer Narrative
Additional information: a2, b3, b4, b5, b6, d4, d6a, d9, d10, g3, h2, h4, h6, h11.The device was returned and evaluation is in progress.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Additional information was received indicating the event involved the patient's left eye, and the patient reported experiencing a visual haze prior to the exchange procedure.During the intraocular lens exchange procedure, the surgeon intended to use the same model iol as the original device.However, due to the structure of the capsular bag, the same model could not be implanted, and a different model iol was used.
Additional Manufacturer Narrative
Additional information: b4, g3, h2, h11.Based on additional information received, the device causality was assessed as unrelated to the event, and therefore this event no longer meets reportability requirements and is no longer deemed reportable.

• 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; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24594367
• Report Number: 0001313525-2026-00014
• Device Sequence Number: 10474617
• Product Code: MFK
• UDI-Device Identifier: 10757770637550
• UDI-Public: (01)10757770637550(17)280731(11)250822(10)3R21532
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: ENU2050
• Device Lot Number: 3R21532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/21/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/16/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC, B+L INJECTOR SYSTEM, FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown