BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCLEAR SPHERE

    MDR report key: 3122628 · Received May 16, 2013

    Report

    Report Number
    9614392-2013-00027
    Event Type
    Other
    Date Received
    May 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPL
    PMA / PMN Number
    K952152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE BY A PT WHO STATED THEY HAD AN EYE INFECTION IN BOTH THE LEFT AND RIGHT EYE. THE PT CONSULTED AN EYE DOCTOR. COOPERVISION WAS UNABLE TO OBTAIN SPECIFIC INFO ON THE DIAGNOSIS. LENSES WERE RETURNED AND INSPECTED. COOPERVISION ANALYZED AND INSPECTED THE RETURNED LENSES AND ESTABLISHED THAT THE LENS PARAMETERS WERE WITHIN STANDARD SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217390 PROCLEAR SPHERE LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION MANUFACTURING, LTD. 9578106615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other