MAUDE Adverse Event Report: Bausch + Lomb Inc. enVista Toric Intraocular Lens; Lens, Intraocular, Toric Optics

Model Number	ETE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported following left eye intraocular lens (iol) implantation, the patient experienced glare.Approximately three months later, the implanted iol was explanted and replaced with a different model lens of a different power.The patient subsequently recovered.
Additional Manufacturer Narrative
The device was returned and evaluated.Evaluation revealed the lens was cut into two pieces and a complete haptic was attached to each side.The device history review (dhr), lot history, 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 Toric Intraocular Lens
• Common Device Name: Lens, Intraocular, Toric Optics
• Manufacturer (Section D): Bausch + Lomb Inc.; 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 ; +1(727)724-6600
• MDR Report Key: 50854959
• Report Number: 0001313525-2026-00146
• Device Sequence Number: 9508638
• Product Code: MJP
• UDI-Device Identifier: 10757770611796
• UDI-Public: (01)10757770611796(17)270630(11)240726(10)3Q19834
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: ETE
• Device Catalogue Number: ETEU150+250
• Device Lot Number: 3Q19834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: 76 YR
• Patient Sex: Unknown