BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAAR SURGICAL

    MDR report key: 4202370 · Received October 23, 2014

    Report

    Report Number
    4202370
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 5, 2014
    Manufacturer
    STAAR SURGICAL
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT UNEVENTFUL ICL SURGERY (B)(6) 2014 OU. PATIENT PRESENTED EIGHT DAYS POST-OP WITH CELLS AND FLARE OS. PATIENT STATED VISION WOULD BE BLURRY FIRST THING IN THE MORNING BUT WOULD CLEAR. INCREASED STEROID AND ANTIBIOTIC. REFERRED TO RETINAL SURGEON (B)(6) 2014 BECAUSE SYMPTOMS WERE NOT RESOLVING. RETINAL SURGEON CULTURED OS AND INJECTED ANTIBIOTIC AND STEROID OS. NO GROWTH AT 48 AND 72 HOURS. VA CONTINUED TO BE 20/20 OS AT ALL VISITS. ON (B)(6) 2014 PATIENT PRESENTED COMPLAINING OF PAIN AND SIGNIFICANT DECREASE IN VISION OS. PRESSURE WAS 45 OS. PATIENT DIAGNOSED WITH ANGLE CLOSURE EVENT. PILO GTTS X 2, 250MG X2 DIAMOX TABS PO GIVEN, PI ENLARGED. PATIENT STAYED AT THE CENTER, PRESSURE DROPPED, CORNEA BEGAN TO CLEAR. PATIENT WAS DISCHARGED WHEN STABLE. RECHECK NEXT DAY, VA 20/25 OS, PAIN GONE. PT DOING WELL. SURGEON SPOKE WITH MEDICAL MONITOR FOR STAAR. ARRANGED BY (B)(6) (STAAR) (B)(6) 2014. REFERENCE MFR NUMBER 2023826-2014-00828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675234 STAAR SURGICAL ICL LZS STAAR SURGICAL MICL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention