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)
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 after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with 4+ cell in anterior chamber with small sterile hypopyon.The patient noticed the problem within a week post-op, with best corrected visual acuity (bcva) decreasing to 20/60.In the surgeon's opinion, the most likely cause of the event is tass.Patient outcome is good, with uncorrected visual acuity of 20/25.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) and pred forte q 1 hr alternating os medrol dose pack oral.
Additional Manufacturer Narrative
Correction: h7, h9.Additional information: g3, h2, h6, h11.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.

• 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: 21908552
• Report Number: 0001313525-2025-00101
• Device Sequence Number: 14508432
• Product Code: MFK
• UDI-Device Identifier: 10757770637284
• UDI-Public: (01)10757770637284(17)270531(11)240602(10)3Q14525
• 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,Followup
• 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: ENU2150
• Device Lot Number: 3Q14525
• 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
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2024
• 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: 69 YR
• Patient Sex: Female