BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILES AQUACOMFORT PLUS

    MDR report key: 3913140 · Received June 11, 2014

    Report

    Report Number
    1065835-2014-00006
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 5, 2014
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPEC. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MFG PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL (ECP) THAT A PT DEVELOPED IRRITATION FROM CONTACT AND THE PT IS GOING BACK TO THEIR PREVIOUS BRAND OF LENSES. ADD'L INFO RECEIVED FROM ECP ON (B)(6) 2014 STATING THAT THE PT WAS DIAGNOSED WITH A PERIPHERAL CORNEAL ULCER, 1-2MM IN SIZE IN THE RIGHT EYE. THE PT EXPERIENCED SEVER PAIN/DISCOMFORT, MODERATE REDNESS, NO DISCHARGE, NO ANTERIOR CHAMBER REACTION, NO INFILTRATE, PERMANENT SCARRING, AND MILD CORNEAL STAINING COVERING LESS THAN 50% OF THE CORNEA. THE PT WAS PRESCRIBED ZYMAXID EYE DROPS, 1 DROPS EVERY HOUR FOR 5 DAYS AND THEN TAPERED. FOLLOW UP WAS SCHEDULED FOR (B)(6) 2014. THE BEST CORRECTED VISUAL ACUITY BEFORE AND AFTER THE EVENT WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343840 DAILES AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL A036260

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other