BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS

    MDR report key: 15596965 · Received October 12, 2022

    Report

    Report Number
    MW5112605
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 11, 2022
    Manufacturer
    STAAR SURGICAL AG
    Product Code
    QCB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT USED ONE DROP IN EACH EYE OF VUITY. SHORTLY AFTER ADMINISTERING THE DROPS, THE REFRACTIVE ERROR HAD A VERY SIGNIFICANT MYOPIC SHIFT. THE PATIENT'S PRESCRIPTION WAS ABOUT -1.00 DIOPTERS PRIOR TO INSTILLING THE MEDICATION. WITHIN 30 MINUTES OF USING THE EYEDROPS, THE PRESCRIPTION CHANGED TO GREATER THAN -6.00 DIOPTERS, RENDERING THE PATIENT ILLEGAL TO DRIVE AND UNABLE TO CLEARLY VIEW ANYTHING BEYOND SIX INCHES FROM HIS NOSE. THE PATIENT HAD IMPLANTABLE COLLAMER LENS SURGERY IN 2012. IT IS PRESUMED THAT THE PUPIL CONSTRICTION CAUSED A SHIFT IN LOCATION OF THE INTRAOCULAR LENS, MAKING A LARGE MYOPIC SHIFT IN THE REFRACTIVE ERROR. FORTUNATELY, THIS WAS REVERSIBLE BY DILATING THE PATIENT'S EYES WITH ONE DROP OF 0.5% TROPICAMIDE AND VISION RETURNED TO ITS PREVIOUS STATE. ALLERGAN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046449 IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL AG T4245

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other VUITY