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

Model Number	BLIS-R1
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
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
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
Additional information: b4, g3, g6, h2, h6 and h11.Although requested, the device was not returned for evaluation.As a serial 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 could not be conclusively determined.Bausch + lomb will continue to monitor similar occurrences.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM HANDPIECE
• 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; 499 sovereign court; manchester MO 63011
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; 7277246600
• MDR Report Key: 25057702
• Report Number: 0001313525-2026-00043
• Device Sequence Number: 9399971
• Product Code: MSS
• UDI-Device Identifier: 00757770520176
• UDI-Public: (01)00757770520176
• 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): 06/28/2026

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-R1
• 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: 06/11/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOOP KEEPERTP613, BLIS-X1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown