BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVUE MULTIFOCAL CONTACT LENS

    MDR report key: 2031299 · Received March 16, 2011

    Report

    Report Number
    1034196-2011-00001
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 15, 2011
    Manufacturer
    UNILENS CORP., USA
    Product Code
    HPX
    PMA / PMN Number
    K960926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. THE ACCOUNT INDICATED THAT THE LOT NUMBER OF THE DISPENSED PRODUCT WAS NOT RECORDED. REVIEW OF ACCOUNT AND PATIENT RECORDS ISOLATED FOUR POSSIBLE LOTS THAT THE PRODUCT COULD BE FROM R86014911, R86021108, R06029906, AND R06009015. OF THE FOUR LOTS, TWO LOTS (R06029906 AND R06009015) HAVE AVAILABLE INVENTORY THAT WAS EXAMINED FOR PACKAGE INTEGRITY AND STERILITY. STERILITY TESTING ON SAMPLES OF THESE TWO LOTS WILL BE CONCLUDED THE WEEK OF (B)(4) 2011. THE CONTRACT MANUFACTURER OF THE PRODUCT HAS BEEN CONTACTED AND IS PERFORMING LOT HISTORY REVIEWS OF THE PROCESSING OF THE FOUR SUSPECT LOTS FOR STERILIZATION EFFECTIVENESS AND OTHER REPORTS OF INFECTION.

    Description of Event or Problem · 1

    THE PATIENT IS A CONTACT LENS USER, AND FELT THERE WAS SOMETHING ON THE LENS WHEN FIRST USED OUT OF THE PACKAGE, BUT USED THE LENS ANYWAY DUE TO LACK OF TIME. AFTER ONE HOUR, THE PATIENT HAD A SIGNIFICANT FOREIGN BODY SENSATION WITH BLURRY VISION, AND REMOVED THE LENS WITHIN 3 HOURS. ON (B)(6) PATIENT PRESENTED TO THE EYECARE PRACTITIONER WITH AN INFECTION IN THE RIGHT EYE, AND PRESENTED TO AN OPHTHALMOLOGIST ON (B)(6). THE INFECTION WAS DESCRIBED AS POSSIBLY (B)(6); A CULTURE TAKEN WAS (B)(6). THE TREATMENT WAS A PROPHYLACTIC ANTIBIOTIC AND BANDAGE CONTACT LENS, ADDING A CYCLOPLEGIC AGENT FOR COMFORT WITH ORAL ANTIVIRAL AGENT AND ORAL PAINKILLER. THE VISUAL PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVUE MULTIFOCAL CONTACT LENS SOFT CONTACT LENS HPX UNILENS CORP., USA CVUE MULTIFOCAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PATIENT USES OPTIFREE CONTACT LENS SOLUTION FOR| CLEANING AND CONDITIONING