BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE (NARAFILCON B)

    MDR report key: 2932512 · Received January 24, 2013

    Report

    Report Number
    1033553-2013-00008
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 24, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K100349
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM A PT'S SPOUSE ON (B)(6) 2013. THE EMAIL STATED: "I AM CONTACTING ACUVUE CUSTOMER SERVICE TODAY IN COMPLETE AND UTTER RAGE. YESTERDAY AFTERNOON MY (SPOUSE) CUT (HIS/HER) RETINA WHILE USING YOUR GUYS CONTACT LENS. AFTER EXAMINATION THE LENS HAD A SHARP EDGE TO IT AND WHEN (HE/SHE) ATTEMPTED TO PUT IT IN IT MADE A FINE CUT ON (HIS/HER) EYE. (HE/SHE) IS CURRENTLY IN THE HOSPITAL AND JUST FINISHED UNDERGOING SURGERY. SO FAR WE HAVE PAD ALMOST 2,000 DOLLARS IN MEDICAL BILLS AND I AM SERIOUSLY PISSED OFF. I AM GOING TO FOLLOW LEGAL PROCEDURES ON YOU GUYS. I HAVE TALKED TO A LAWYER ABOUT THE SITUATION AND WILL BE FOLLOWING THROUGH ON THIS UNLESS YOU GUYS CAN COME UP WITH A SERIOUS RESOLUTION." NUMEROUS ATTEMPTS TO CONTACT THAT PT HAVE BEEN UNSUCCESSFUL. THE PRECISE NATURE OF THE REPORTED INJURY IS UNKNOWN; THIS IS BEING REPORTED AS WORST CASE. THE LOT NUMBER IS UNK. IF ADDITIONAL MEDICAL INFO IS RECEIVED, WE WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34742 1-DAY ACUVUE TRUEYE (NARAFILCON B) SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other