MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	EN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.
Event or Problem Description
It was reported that 1-day after implantation of an intraocular lens (iol) into the right eye (od), the patient presented with 3+ cell with hypopyon.Patient's best corrected visual acuity (bcva) decreased to 20/80.It was presumed to be bacterial endophthalmitis, a culture was performed to identify the cause.Results of the culture were negative, confirming the event was toxic anterior segment syndrome (tass), not endophthalmitis.At 3 days post-op a vitrectomy was performed, and an intravitreal injection of vancomycin/ceftazidime was administered.In the surgeon's opinion, the most likely cause of the event is something in the packaging causing tass.Patient outcome is good.Medications administered during original surgery: intracameral moxifloxacin the following medications were prescribed for use at home post-operatively: combo drop (prednisolone sodium phosphate-moxifloxacin-bromfenac-sterile ophthalmic solution) 1 drop twice a day.

• Brand Name: ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21903388
• Report Number: 0001313525-2025-00099
• Device Sequence Number: 19889060
• Product Code: MFK
• UDI-Device Identifier: 10757770637291
• UDI-Public: (01)10757770637291(17)271031(11)241101(10)3Q29406
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: EN
• Device Catalogue Number: ENU2200
• Device Lot Number: 3Q29406
• 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: 04/16/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96594
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B+L INJECTOR SYSTEM, AMVISC PLUS, ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male