BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVUE ADVANCED HYDRAVUE CONTACT LENS

    MDR report key: 3445471 · Received October 28, 2013

    Report

    Report Number
    1034196-2013-00001
    Event Type
    Injury
    Date Received
    October 28, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 21, 2013
    Manufacturer
    UNILENS CORP., USA
    Product Code
    LPL
    PMA / PMN Number
    K100456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN SPITE OF REPEATED ATTEMPTS AT CONTACT, NO FURTHER INFORMATION WAS RECEIVED FROM THE PRACTITIONER AFTER THE INITIAL REPORT. THE DEVICE WAS RECEIVED BY THE MANUFACTURER ON (B)(4) 2013. PRODUCT HAD BEEN RESEALED BY THE ACCOUNT. THE PRODUCT WAS REMOVED FROM THE PACKAGING AND DECONTAMINATED FOR PHYSICAL INSPECTION. NO SAMPLES WERE TAKEN FOR BIOLOGICAL TESTING, AS THE PRODUCT WAS RETURNED NON-STERILE AND NO ORGANISM WAS DESCRIBED BY THE PRACTITIONER. PRODUCT INSPECTION VERIFIED THE PRODUCT MEETS SPECIFICATIONS. THERE ARE TEARS IN THE LENS SURFACE FROM DECONTAMINATION HANDLING. THERE ARE NO DEFECTS IN THE PACKAGING SEALS OR VIAL. THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED WITH NO ANOMALIES FOUND THAT COULD IMPACT PRODUCT STERILITY. THE CYCLE VALIDATION WAS REVIEWED AND FOUND ACCEPTABLE FOR (B)(4). THERE IS NO INDICATION OF COMPROMISED STERILITY OR INTEGRITY OF PACKAGING. WHILE NO ABSOLUTE CONCLUSION CAN BE DRAWN, THE SOURCE OF THE INFECTION IS PROBABLY PATIENT HYGIENE OR HANDLING THE PRODUCT IN A MANNER INCONSISTENT WITH THE LABELING.

    Description of Event or Problem · 1

    PATIENT INDICATED OS CONTACT LENS WAS UNCOMFORTABLE AT FITTING. PRACTITIONER HAD PATIENT RINSE LENS AND THEN IT FELT BETTER. THE NEXT DAY, THE PATIENT HAD THE SAME DISCOMFORT AND REMOVED THE LENS. THE PATIENT THEN PRESENTED TO THE PRACTITIONER WITH AN EYE INFECTION. THE PRACTITIONER TREATED THE INFECTION WITH HEAVY ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551433 CVUE ADVANCED HYDRAVUE CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR LPL UNILENS CORP., USA CUSTOMIZED TORIC 717538

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other