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 Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with increased anterior chamber cells & fibrin.Patient's bcva did not decrease.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).In the surgeon's opinion, the most likely cause of the event is related to iol storage media.Patient outcome is good.The following medications were prescribed (for use at home post-operatively): tobradex 1 gtt every hour, zymamid 1 gtt every hour, avelox 400g qd 1 week.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.

• 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: 21864665
• Report Number: 0001313525-2025-00058
• Device Sequence Number: 7767962
• Product Code: MFK
• UDI-Device Identifier: 10757770637307
• UDI-Public: (01)10757770637307(17)271130(11)241210(10)3Q33821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: ENU2250
• Device Lot Number: 3Q33821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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: PLATINUM INJECTOR, ALCON BSS, HEALON PRO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female