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	Ejection Problem (4009)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per the reporter, the device is not available for analysis.As a lot 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 information provided, a root cause of this event could not be determined.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol) into the right eye, the lens unfolded too quickly causing zonular damage and iol decentration.The incision was enlarged to allow for removal of the lens, a different model iol was implanted into the sulcus, and the incision was closed with sutures.In the surgeon¿s opinion, the most likely cause of the event was quick unfold of lens after implant.Patient outcome is good.

• 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): BAUSCH + LOMB; medicel ag; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22478155
• Report Number: 0001313525-2025-00146
• Device Sequence Number: 8554778
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: BLIS-X1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA TORIC INTRAOCULAR LENS, DUOVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female