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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Macular Edema (1822); Endophthalmitis (1835); Visual Impairment (2138); Vitreous Detachment (2445)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.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 available information, the root cause of this event could not be conclusively determined.
Event or Problem Description
It was reported that 6 days after implantation of an intraocular lens (iol) in the right eye (od) the patient presented with clinical findings consistent with acute endophthalmitis accompanied by a decrease in visual acuity from counting fingers at 4 feet to hand motion.The patient was referred the same day to a retina specialist, who performed a culture and administered an intraocular injection.The culture showed no growth.Approximately eight weeks later, the patient underwent a pars plana vitrectomy to address a posterior vitreous detachment (pvd).At the postoperative visit the following day, the retina specialist documented: resolved acute endophthalmitis with structurally stable findings, central retinal vein occlusion with macular edema od, epiretinal membrane in both eyes (ou), resolved pvd od, and pvd left eye (os).In the implanting surgeon's opinion, the most likely cause of the event could not be determined.The most recent recorded visual acuity for the affected eye was no light perception (nlp).The following medications were prescribed for use at home post-operatively: prednisolone 1%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month), ofloxacin 0.3%: 1 gtt qid x 7 days, ketorolac 0.5%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month).Medications documented at retina visit on (b)(6) 2026: ciprofloxacin: 0.3% 1 gtt qid od, prednisolone acetate: 1% 1 gtt qid od, systane: 1 gtt bid ou.

• 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; altenrhein CH ¿9 423; SZ CH ¿9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25550902
• Report Number: 0001313525-2026-00076
• Device Sequence Number: 10762373
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• 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: ENVISTA IOL, AMVISC PLUS, BLIS-R1, ALCON BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female