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 Codes	Corneal Edema (1791); Inflammation (1932)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of this event is ongoing and a follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol) the haptic was torn.The incision was enlarged and a different model iol was implanted.A suture was used to help close the wound.Post-operatively the patient was diagnosed with corneal edema and inflammation, however according to the surgeon the patient is improving.In the surgeon¿s opinion the most likely cause of the event is the manner lens was loaded into the cartridge by the scrub tech.

• 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: 25368663
• Report Number: 0001313525-2026-00063
• Device Sequence Number: 13403958
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/22/2026; 07/17/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/17/2026; 07/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown