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

Model Number	ETN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patients eye and is not available for evaluation.The investigation of this event is ongoing and a follow-up report will be submitted upon completion.
Event or Problem Description
During insertion of the intraocular lens (iol), the trailing haptic caught in the cartridge as it was being advanced.The haptic was freed and the lens was subsequently implanted in the patient¿s eye.The haptic was found to be cracked and dislocated from the capsular bag, migrating into the sulcus.Two weeks post implant the haptic was repositioned back into the capsular bag.The lens remains implanted.
Additional Manufacturer Narrative
Additional information: b4, g3, h2, h6 and h10/11.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, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.

• 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, INC; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24685638
• Report Number: 0001313525-2026-00019
• Device Sequence Number: 13263051
• Product Code: MFK
• UDI-Device Identifier: 10757770640796
• UDI-Public: (01)10757770640796(17)280930(11)251016(10)3R28138
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: ETNU150+170
• Device Lot Number: 3R28138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• 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, SINSKEY HOOK, BLIS INSERTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown