BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

    MDR report key: 21853875 · Received April 17, 2025

    Report

    Report Number
    0001313525-2025-00051
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 15, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MFK
    UDI-DI
    10757770641984
    PMA / PMN Number
    P240005
    Removal / Correction Number
    RES96594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, THIS COMPLAINT IS NOT REPORTABLE AS PER 21 CFR 803.

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED. INVESTIGATION OF THIS EVENT IS IN PROGRESS. RECALL OF DEVICE IS UNDERWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1-DAY POST-IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH TRACE INJECTION, 2+RR. 4+ CELL WITH FIBRIN, EARLY PUPILLARY FIBRIN MEMBRANE, AND <1MM NEW LAYERED HYPOPYON. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A SUB-TENON INJECTION OF VANCOMYCIN/CEFTAZIDIME WAS ADMINISTERED. IN THE SURGEON'S OPINION THE MOST LIKELY CAUSE OF THE EVENT IS INFECTION FROM SURGERY-CAUSE UNKNOWN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): PRED-MOXI-BROM 1%/0.5%/0.075% 1GTT QID UNTIL SEEN. PREDNISOLONE 1% 1GTT Q1H UNTIL SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113967 ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK BAUSCH + LOMB ETN 3Q26728 10757770641984

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention ALCON MONARCH INJ + D CARTRIDGE, ALCON BSS, DUOVISC.