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 Code	Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately six months after implantation of an intraocular lens (iol) in the patient's dominant right eye (od), the lens was exchanged with a different model due to persistent halos experienced during both daytime and nighttime conditions.Prior to the lens exchange, the surgeon attempted to manage the symptoms by treating the patient's dry eye; however, the halos remained unresolved.In the surgeon's opinion, the most likely cause of the event was the patient's visual system/brain inability to tolerate halo phenomena associated with multifocal iols, noting that such symptoms can occur with all multifocal lenses.Additional information was requested but not received.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation, and additional information was not received.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.

• 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 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50438925
• Report Number: 0001313525-2026-00126
• Device Sequence Number: 21167744
• Product Code: MFK
• UDI-Device Identifier: 10757770637291
• UDI-Public: (01)10757770637291(17)280229(11)250303(10)3R05550
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: ENU2200
• Device Lot Number: 3R05550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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: 72 YR
• Patient Sex: Female