MAUDE Adverse Event Report: Bausch + Lomb enVista Envy toric hydrophobic acrylic intraocular lens; Lens, Multifocal Intraocular

Model Number	ETN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the right eye, the patient was dissatisfied with the postoperative visual outcome.Initially, the patient declined an iol exchange due to satisfaction with near vision.Subsequently, the iol was exchanged with a different model lens.Additional information was requested but not received.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information was not provided.As a serial number for the device was not provided, the associated device history record was not reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.

• Brand Name: enVista Envy toric 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 n park pl blvd; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50889711
• Report Number: 0001313525-2026-00150
• Device Sequence Number: 10758737
• Product Code: MFK
• UDI-Device Identifier: 10757770642912
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/24/2026

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: ETN
• Device Catalogue Number: ETNU300+090
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 52 YR
• Patient Sex: Unknown