BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE BRAND CONTACT LENS

    MDR report key: 4081115 · Received August 29, 2014

    Report

    Report Number
    1033553-2014-00074
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 29, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING: SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    ON (B)(6)2014, OUR FIRM SPOKE WITH AN EYE CARE PROFESSIONAL (ECP) WHO REPORTED THAT A PATIENT (PT) WAS SEEN AT A CLINIC WITH SEVERE REDNESS, EYE DISCHARGE, AND THOUGHT IT WAS AN INFECTION. ON (B)(6) 2014 THE ECP REPORTED THAT THE PATIENT HAD BEEN SEEN ON (B)(6) 2014. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ULCER OD. THE ECP STATES THAT THE PATIENT'S OD WAS VERY RED AND THE "CORNEAL ULCER LOOKED WHITE". THE ECP REPORTED THE PATIENT HAD THE SYMPTOM FOR A WEEK AND THE PATIENT STARTED TO USE THE CL IN QUESTION TWO DAYS AGO. THE ECP EXPRESSED DOUBT ABOUT THE INFO PROVIDED BY THE PATIENT. THE ULCER WAS REPORTED TO BE ABOUT 1.5MM. THE ULCER WAS LOCATED AT 6 O'CLOCK, A LITTLE BELOW THE PUPIL AREA. THE PATIENT'S VA WAS NOT AFFECTED. THE PATIENT'S CORRECTED VA WAS 1.0. THE ECP DETERMINED THAT THE ULCER WAS INFECTIOUS BECAUSE THE PATIENT HAD EYE DISCHARGE AND REDNESS. NO CULTURES WERE PERFORMED. THE PATIENT WAS PRESCRIBED CRAVIT 1.5% QID FOR OD. THE PATIENT WAS INSTRUCTED TO DISCONTINUE CL WEAR UNTIL FULL RECOVERY. THE PATIENT WAS INSTRUCTED TO CONSULT THE PATIENT'S PRESCRIBING ECP FOR F/U ON FRIDAY (B)(6) 2014. "THE ECP DETERMINED THAT THE PATIENT'S SYMPTOM WAS MILD TO MODERATE AT THIS POINT AND IT MIGHT BE MODERATE TO SEVERE". "THE ECP DETERMINED THAT THIS EVENT WAS CAUSED BY CL." THE ECP DID NOT WANT TO PROVIDE ANY ADD'L INFO. THE LOT # IS UNKNOWN AND THE PRODUCT WAS NOT AVAILABLE FOR RETURN FOR EVALUATION. NO LOT NUMBER WAS AVAILABLE, THEREFORE NO DEVICE HISTORY REVIEW CAN BE CONDUCTED. BASED ON ALL AVAILABLE INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. ANY ADD'L INFO REC'D WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527644 ACUVUE BRAND CONTACT LENS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention