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

Model Number	ETN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the right eye (od), the patient presented with 4+ cell, fibrin, and hypopyon.The patient's best corrected visual acuity (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 possible tass from the iol.The inflammation resolved after treatment, and patient outcome is good.Medications prescribed for use at home post-operatively: pred/moxi/brom 1%/0.5%/0.075% tid x 1 week, qd 3 weeks.Durezol every hour.Medrol po dose pack.
Additional Manufacturer Narrative
Additional info: b5, g3, h2, h11.
Event or Problem Description
Additional information was received indicating the tass event may have been caused by a cannula and unrelated to the lens.

• Brand Name: ENVISTA ENVY TORIC 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 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22713598
• Report Number: 0001313525-2025-00154
• Device Sequence Number: 21313195
• Product Code: MFK
• UDI-Device Identifier: 10757770644237
• UDI-Public: (01)10757770644237(17)271231(11)250130(10)3R02223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: ETN
• Device Catalogue Number: ETNU425+180
• Device Lot Number: 3R02223
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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: ALCON MONARCH IV, AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male