BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE (NARAFILCON B)

    MDR report key: 2960539 · Received February 12, 2013

    Report

    Report Number
    1033553-2013-00010
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    February 14, 2011
    Report Date
    February 12, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K100349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHILE REVIEWING INFORMATION ON THE CLINICALTRIALS.GOV WEBSITE, AN ASSOCIATE IN OUR FIRM FOUND A SUBJECT TAKING PART IN A CLINICAL TRIAL FOR CIBA VISION WAS WEARING A 1-DAY ACUVUE TRUEYE CONTACT LENS AND DEVELOPED A STERILE INFILTRATE WITH A SECONDARY IRITIS. (B)(4). ON (B)(6) 2011, THE SUBJECT AWOKE WITH PAIN AND PHOTOPHOBIA. THE PT WAS EXAMINED BY THE INVESTIGATOR THAT DAY AND WAS FOUND TO HAVE A STERILE INFILTRATE WITH SECONDARY IRITIS. THE INFILTRATE WAS 1 X 2 MM AND THE IRITIS WAS QUANTIFIED AS 1 TO 3 CELLS WITH DROPS ON DAY 1 AND TOBRADEX DROPS Q1H ON DAY ONE AND THEN QID. THE SUBJECT WAS SEEN FOR FOLLOW-UP ON (B)(6) AND THE LAST VISIT WAS ON (B)(6) 2011; THE STERILE INFILTRATE AND IRITIS HAD RESOLVED AND THE PT RESUMED THE STUDY. THE LENSES WERE NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATIONS. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT 1338250105 WAS PRODUCED UNDER NORMAL CONDITIONS. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60887 1-DAY ACUVUE TRUEYE (NARAFILCON B) SOFT CONTACT LENS LPL VISTAKON NA 1338250105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other