MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC PLUS VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Model Number	60081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Blurred Vision (2137); Eye Pain (4467)
Date of Event	09/25/2025
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 following an intraocular lens (iol) implantation in the right eye, the patient had pain and blurred vision.Two (2) days post procedure, the patient presented for emergency care at another healthcare facility with severe pain and symptoms of endophthalmitis.The patient was hospitalized and on the second day, a vitrectomy with silicone oil administration was performed.A microbiological culture identified enterococcus faecalis infection.Antibiotic therapy (including vancomycin) was initiated.Four (4) days post-secondary procedure, the patient was discharged from the hospital with preserved vision of 1/50, without pain and the iol remains implanted.
Additional Manufacturer Narrative
Updated d4, d9, g3, g6, h2, h4, h6 and h11.The device is not available for evaluation as it was discarded.The lot history, trend analysis, risk analysis and 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 determined.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 23435574
• Report Number: 0001313525-2025-00199
• Device Sequence Number: 18310877
• Product Code: LZP
• UDI-Device Identifier: 00757770495672
• UDI-Public: (01)00757770495672(17)270430(11)240521(10)030737
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810025
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: 60081L
• Device Lot Number: 030737
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: IOL, EYEFILHD, BSS, VISCOJECTINJ, CUSTOMPACK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female