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	Endophthalmitis (1835); Hypopyon (1913); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that 1 day after implantation of an intraocular lens (iol) into the left eye (os) of a patient endophthalmitis occurred in the operated eye.At the one-day post op slit lamp findings the surgeon noted hypopyon, ac cells and flare, a decrease in patients bcva.Initial treatment consisted of topical moxifloxacin and prednisone acetate.Two days after the initial procedure the patient had an elevated iop of 36mmhg.Three days after the lens was initially placed a vitrectomy was performed.Culture and sensitivity performed was positive for enterococcus faecalis.Intraocular injections with an unspecified medication were administered for endophthalmitis treatment on postoperative day 5 and postoperative day 7 following the original iol placement.At the time of reporting, the patient¿s prognosis and ongoing treatment course were described as good.
Additional Manufacturer Narrative
The device was discarded per the reporter and therefore not available for evaluation.A review of device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for 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; alternhein FL CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL ; 7277246600
• MDR Report Key: 24780426
• Report Number: 0001313525-2026-00026
• Device Sequence Number: 9935423
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183(17)261026(11)241028(10)2402709
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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 Catalogue Number: BLIS-X1
• Device Lot Number: 2402709
• 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: 03/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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: BLIS R1 HANDPIECE AND ENVISTA INTRAOCULAR LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female