MAUDE Adverse Event Report: Bausch + Lomb AMVISC PLUS Viscosurgical Device; Aid, Surgical, Viscoelastic

Model Number	60081L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Macular Edema (1822); Endophthalmitis (1835); Visual Impairment (2138); Vitreous Detachment (2445)
Date of Event	03/04/2026
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
It was reported that 6 days after implantation of an intraocular lens (iol) in the right eye (od) the patient presented with clinical findings consistent with acute endophthalmitis accompanied by a decrease in visual acuity from counting fingers at 4 feet to hand motion.The patient was referred the same day to a retina specialist, who performed a culture and administered an intraocular injection.The culture showed no growth.Approximately eight weeks later, the patient underwent a pars plana vitrectomy to address a posterior vitreous detachment (pvd).At the postoperative visit the following day, the retina specialist documented: resolved acute endophthalmitis with structurally stable findings, central retinal vein occlusion with macular edema od, epiretinal membrane in both eyes (ou), resolved pvd od, and pvd left eye (os).In the implanting surgeon's opinion, the most likely cause of the event could not be determined.The most recent recorded visual acuity for the affected eye was no light perception (nlp).The following medications were prescribed for use at home post-operatively: prednisolone 1%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month) ofloxacin 0.3%: 1 gtt qid x 7 days ketorolac 0.5%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month) medications documented at retina visit on 4/29/2026: ciprofloxacin 0.3%: 1 gtt qid od prednisolone acetate 1%: 1 gtt qid od systane: 1 gtt bid ou.

• 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 ; +1(727)724-6600
• MDR Report Key: 25551570
• Report Number: 0001313525-2026-00075
• Device Sequence Number: 14865240
• Product Code: LZP
• UDI-Device Identifier: 00757770495672
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P810025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 60081L
• Device Lot Number: 031457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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, ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female