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

Model Number	59081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Red Eye(s) (2038); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an uncomplicated intraocular lens (iol) implantation in the left eye, the patient presented with decreased visual acuity, red eye, positive tyndal's and suspected tass.Five (5) days post procedure, a secondary intervention was performed at another healthcare facility and the iol was explanted and replaced with an unknown iol.Additional information was requested, but not received.
Additional Manufacturer Narrative
Investigation of the event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Updated b5, d4, g3, g6, h2, h4, h6 and h11.Although requested, the device was not returned.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.
Event or Problem Description
Additional information was received.We were informed the patient is fine and additional information is not available.

• Brand Name: AMVISC 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: 22335615
• Report Number: 0001313525-2025-00138
• Device Sequence Number: 9126599
• Product Code: LZP
• UDI-Device Identifier: 00757770495658
• UDI-Public: (01)00757770495658(17)270131(11)240702(10)030676
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 59081L
• Device Lot Number: 030676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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: AKREOS IOL, AI-28, BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male