MAUDE Adverse Event Report: BAUSCH + LOMB TOTALVISC VISCOELASTIC SOLUTION; AID, SURGICAL, VISCOELASTIC

Model Number	TVISC20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day post an uncomplicated cataract extraction and implantation of an intraocular lens (iol) into the eye, the patient¿s visual acuity was 20/30.The patient¿s visual acuity decreased over the next week and a half and the iol was observed to be white and opaque.An intraocular injection of antibiotics was administered as a precaution.One month after implant, the surgeon attempted to remove the iol, but observed an inflammatory membrane, allegedly as a result of tass, and removed the membrane.The iol was determined to be clear and remains implanted.Additional information was requested, but not received.
Additional Manufacturer Narrative
Although requested, the device has not been returned for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Although requested, the device has not been returned for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Additional information received clarified that the fibrous membrane was on the anterior optic of the lens.The patient is recovering.
Additional Manufacturer Narrative
Additional information: g3, h2, h6, h11 the device was discarded and 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.

• Brand Name: TOTALVISC VISCOELASTIC SOLUTION
• 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 53318
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21463095
• Report Number: 0001313525-2025-00017
• Device Sequence Number: 8750218
• Product Code: LZP
• UDI-Device Identifier: 10757770601735
• UDI-Public: (01)10757770601735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P220009
• 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,Followup,Followup
• Report Date (Section B): 01/29/2025

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: TVISC20
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 04/02/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/04/2025
• 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 ASPIRE IOL, BSS, BLIS-R1, BLIS-X1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male