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	Loss of Vision (2139); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the one-day post-operative visit after implantation of an intraocular lens (iol) into the right eye, the surgeon noted the patient presented with 1-2+ edema, seidel sign, and cell 2+ fibrin in ac.This reaction was diagnosed as toxic anterior segment syndrome (tass).The patient's bcva decreased from 20/150 to cf @ 1 ft.The day after symptoms were observed, an intravitreal injection of vancomycin & ceftazidime was performed, and a culture was taken.The result of the culture was negative.In the surgeon's opinion, the most likely cause of event is possibly from the visco and lido/phen.Patient outcome is good.The following medications were prescribed for use at home postoperatively: pred-moxi-brom 1%,.5%, 0.075% dose: 1gtt frequency: tid 2 weeks, bid 1 week, qd 1 week neomycin & polymyxin & dexamethasone dose: 1 small ribbon frequency: once prednisolone 1% dose:1gtt frequency: qhourly duration: until directed otherwise.
Additional Manufacturer Narrative
Sealed product from the same lot was returned.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The actual device was not returned for evaluation; however, (b)(4) unused units from the same lot were returned and evaluated.Evaluation of the returned product confirmed that all packaging seals were intact for each component (cannula, retention clip, and syringe).No seals were broken or incomplete and there was no visible integrity or appearance issues with any component or syringe.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.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 could not be conclusively 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 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19940749
• Report Number: 0001313525-2024-00138
• Device Sequence Number: 12000179
• Product Code: LZP
• UDI-Device Identifier: 00757770495672
• UDI-Public: (01)00757770495672(17)260930(10)030458
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 09/30/2026
• Device Model Number: 60081L
• Device Lot Number: 030458
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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: ENVISTA IOL, B+L INJECTOR SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male