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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare facility reported that the intraocular lens (iol) was implanted after accidental rupture of the posterior capsule following aspiration of the crystalline lens cortex.When the lens was injected into the eye it was noted that there was a cut at the edge of the lens optic and a haptic was missing.The incision was enlarged for removal of the lens, and several corneal sutures were used to close the incision.As a suitable lens was not available the patient was left aphakia.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Additional information: b4, g3, g6, h2, h6 and h11.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.Based on the available information the root cause of the event could not be conclusively determined; however, manufacturing related factors may have contributed to this event.Bausch + lomb will continue to monitor 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; 21; alternhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25057701
• Report Number: 0001313525-2026-00042
• Device Sequence Number: 13111414
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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
• Device Lot Number: UNKNOWN
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/17/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOOP KEEPERTP613, BLIS-R1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown