BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE BRAND

    MDR report key: 2172640 · Received July 20, 2011

    Report

    Report Number
    1033553-2011-00049
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 20, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2011 AND REPORTED THAT THE PATIENT FELT HIS/HER LEFT EYE (OS) WAS "DARK". THE PATIENT SAID HIS/HER EYE CARE PROFESSIONAL (ECP) SAID THE EYE WAS FINE. THE DATE OF THIS VISIT WAS NOT PROVIDED. THE PATIENT SAID HE/SHE INSISTED SOMETHING WAS WRONG AND HAD A COMPLETE MEDICAL CHECKUP AT A "HEALTH SCREENING CENTER" "IN 2010". THE PATIENT REPORTED THAT HE/SHE WAS FOUND TO HAVE IRITIS AND ELEVATED INTRAOCULAR PRESSURE. THE PATIENT PROVIDED NO ADDITIONAL INFORMATION REGARDING THIS EVENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION PERTAINING TO THE MEDICAL EVENT AND THE SUSPECT PRODUCT; THE PATIENT HAS NOT RESPONDED TO ANY REQUESTS FOR INFORMATION. IRITIS MAY OR MAY NOT BE ASSOCIATED WITH CONTACT LENS WEAR. AS NO SPECIFIC INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT, THIS REPORT IS BEING SUBMITTED AS A WORST CASE. IF ADDITIONAL MEDICAL OR PRODUCT INFORMATION IS RECEIVED, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE BRAND SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other