MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	BLIS-X1
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
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
The device is not available and cannot be returned.The investigation of this event is ongoing and a follow-up report will be submitted upon completion.
Additional Manufacturer Narrative
Additional information: b4, g3, h2, h6 and h10/11.Although requested, the device was not returned for evaluation.As a lot number for the device was not provided, the associated device history record (dhr) was not reviewed.The 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 the event could not be conclusively determined.Bausch + lomb will continue to monitor for similar occurrences.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; alternhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24685646
• Report Number: 0001313525-2026-00018
• Device Sequence Number: 13263053
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: BLIS-X1
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/30/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC, SINSKEY HOOK, ENVISTA ENVY TORIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown