BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE

    MDR report key: 3842889 · Received May 27, 2014

    Report

    Report Number
    MW5036368
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    Product Code
    LYL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED BIO TRUE CONTACT SOLUTION EXP 02/2016 LOT GB14106 3235802 BL401413:002 AND A FRESH PAIR OF BAUSCH AND LOMB PURE VISION 2 CONTACTS LOT R38535514 EXP 08/2016 AND WITHIN 2 HOURS STARTED TO HAVE BLURRY VISION. IMMEDIATELY WENT TO EYE DOCTOR OPHTHALMOLOGIST AND E.R. AND THEN CORNEA SPECIALIST. DIAGNOSED WITH CORNEAL EDEMA AND WORSENING CORNEAL ABRASION ON RIGHT EYE. WAS ESSENTIALLY BLIND IN BOTH EYES FOR 4 DAYS. TWO CONTACTS, Q 30 DAY. REASON FOR USE: PRESBYOPIA. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310013 BIOTRUE CONTACT SOLUTION LYL G1314106
    310014 PURE VISION 2 CONTACT LENS LPM R38535514

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR