MAUDE Adverse Event Report: BAUSCH + LOMB 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	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgical center reported that 3 days after implantation of an intraocular lens (iol) into the left eye, the patient experienced dysphotopsia.Approximately five months after implantation, the iol was exchanged with a different model iol.
Additional Manufacturer Narrative
The device was returned and evaluated.Examination found the lens in 2 pieces across the optic.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.The 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 determined.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22333601
• Report Number: 0001313525-2025-00135
• Device Sequence Number: 13017794
• Product Code: HQL
• UDI-Device Identifier: 10757770611161
• UDI-Public: (01)10757770611161(17)270831(11)240911(10)3Q24729
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: ETEU125+220
• Device Lot Number: 3Q24729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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: 70 YR
• Patient Sex: Female