BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-VUE55 TORIC MULTIFOCAL

    MDR report key: 3736086 · Received April 4, 2014

    Report

    Report Number
    1034196-2014-00002
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 3, 2014
    Manufacturer
    UNILENS CORP., USA
    Product Code
    LPL
    PMA / PMN Number
    K041608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RECEIVED (B)(4) 2014; LENS WAS SEALED IN PACKAGE WITH VERY LITTLE PACKAGING SALINE, MAKING TESTING FOR ANY ANTIGEN VERY DIFFICULT. PH WAS EVALUATED USING TESTING PAPER, AND FOUND TO BE HIGH WHEN COMPARED TO REPRESENTATIVE SAMPLES OF UNOPENED PRODUCT PROCESSED IN THE SAME TIME PERIOD. (PH 8 IN RETURNED SAMPLE, PH 6+ IN RETAINED UNOPENED SAMPLES). PH SHIFT MAY HAVE CAUSED THE REPORTED IMMEDIATE REACTION IN PT. PT HAS BEEN WEARING LENSES WITHOUT DIFFICULTY FOR SEVERAL YEARS OF THE SAME DESIGN AND MATERIAL; THERE HAVE BEEN NO CHANGES IN PACKAGING. THE DIAGNOSIS OF "CHRONIC ALLERGIC CONJUNCTIVITIS" IS QUESTIONABLE, SINCE THE REACTION WAS IMMEDIATE, ONLY IN ONE EYE (THE SAME STYLE/MATERIAL CONTACT LENS WAS IN THE OTHER EYE), AND NO SWAB WAS TAKEN OF THE EYE FOR CONFIRMATION OF ANY POTENTIAL BIOLOGICAL AGENT. EXAMINATION OF THE PACKAGING SHOWS NO DEFECTS IN THE PACKAGE THAT WOULD HAVE RESULTED IN A COMPROMISE OF STERILITY; IN ADDITION, THERE WAS NO REPORT FROM THE PATIENT OF A DAMAGED SEAL OR LEAKAGE FROM THE PACKAGE BEFORE THE INITIAL USE. EXAMINATION OF THE RETURNED LENS FOUND IT TO BE UNDAMAGED; THE LENS MEETS SPECIFICATIONS AND COSMETIC CRITERIA. NO CONCLUSION CAN BE DRAWN FROM EXAMINATION OF THE RETURNED SAMPLE, SINCE CONTAMINATION IS PROBABLE AFTER HANDLING. PROBABLY AN ENVIRONMENTAL AGENT CAUSED THE IMMEDIATE IRRITATION, SUCH AS CONTAMINANTS ON THE PATIENT'S HANDS.

    Description of Event or Problem · 1

    PT PRESENTED AT THE EYECARE PRACTITIONER'S OFFICE WITH A VERY RED, PUFFY RIGHT EYE. A DIAGNOSIS WAS MADE OF CHRONIC ALLERGIC CONJUNCTIVITIS, ALTHOUGH THE PT HAS BEEN WEARING CONTACTS MADE FROM THE SAME MATERIAL IN BOTH EYES FOR SEVERAL YEARS. THE PT STATED THIS WAS THE FIRST TIME THIS LENS WAS WORN, AND THE REACTION WAS IMMEDIATE WHEN THE LENS WAS INITIALLY PLACED IN THE EYE. THE PT CEASED USE OF THE CONTACT LENSES AND WAS PLACED IN SPECTACLES UNTIL THE EYE QUIETS AND CONTACT LENS WEAR CAN BE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204821 C-VUE55 TORIC MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR LPL UNILENS CORP., USA C-VUE55 66892701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other