BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENSES

    MDR report key: 1790759 · Received August 4, 2010

    Report

    Report Number
    1033553-2010-00048
    Event Type
    Injury
    Date Received
    August 4, 2010
    Report Date
    August 4, 2010
    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

    LABELED FOR SINGLE USE AND REUSE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR (B)(4) AFFILIATE. ON (B)(6) 2010, THE (B)(4) WAS HELD AND INFORMATION WAS PRESENTED ABOUT ACANTHAMOEBA KERATITIS DURING THE LAST 2 YEARS. WE RECEIVED INFORMATION THAT A PT DEVELOPED ACANTHAMOEBA KERATITIS WHILE WEARING ACUVUE 2 LENSES. A SENIOR ASSOCIATE FROM OUR AFFILIATE WENT TO SPEAK WITH THE PRESENTING EYE CARE PROFESSIONAL AND RECEIVED INFORMATION REGARDING THE PT'S GENDER AND AGE AND THAT THE PT WAS DIAGNOSED WITH ACANTHAMOEBA KERATITIS IN THE "INITIAL STAGE." THE PT RECEIVED INPATIENT TREATMENT. THE PT'S MEDICAL RECORD WAS UNAVAILABLE AT THE TIME OF THE VISIT AND THE EYE CARE PROFESSIONAL WAS ASKED FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. THE ECP TOLD US THAT THE PRODUCT AND LOT NUMBER ARE NOT AVAILABLE. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE 2 BRAND CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R