BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA INTRAOCULAR LENS

    MDR report key: 21893664 · Received April 23, 2025

    Report

    Report Number
    0001313525-2025-00071
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 14, 2025
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    UDI-DI
    10757770607928
    PMA / PMN Number
    P910056
    Removal / Correction Number
    RES96594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENT WITH BLURRY VISION WITH BEST CORRECTED DISTANCE VISUAL ACUITY DECREASING TO 20/150 PH, THUMBPRINT FLOATER, 0.2MM HYPOPYON W/TEMPORAL FIBRIN, 3-5 + WHITE CELLS, AND ROBUST INFLAMMATORY RESPONSE CONTINUING INTO THE NEXT DAY. ON DAY 3 POST-OP, THE PATIENT COMPLAINED OF LIGHT SENSITIVITY, SEEING A CHECKERED PATTERN, AND WHITE BLOBS WITH BLACK WORMS EVERYWHERE WITH VISUAL ACUITY FURTHER DECREASING. UPON EXAMINATION, THE SURGEON NOTED INCREASED VITREOUS OPACITIES AND RETINAL HEMORRHAGES AND WAS REFERRED FOR A VITREOUS TAP & INJECTIONS OF 1MG VANCOMYCIN, 100MG CEFTAZIDIME, & 0.4MG DEXAMETHASONE WERE ADMINISTERED. RESULTS OF THE CULTURE & SENSITIVITY WERE NEGATIVE. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: MOXIFLOXACIN GTT 0.5% 3X 1 DAY (INCREASED TO AID) TAPER. PREDNISOLONE GTT 1% 3X 1 DAY (INCREASED Q HOUR) TAPER. PROLENSA GTT 0.07% 1 X DAY (INCREASED QID) TAPER. MEDROL PACK 4 MG TAB TAKE AS DIRECTED ON PACK. DUREZOL 0.05% 1 GTT Q HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628742 ENVISTA INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH + LOMB EE 3Q26255 10757770607928

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention DUOVISC, ALCON BSS, B+L INJECTOR SYSTEM.