BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR MULTIFOCAL CONTACT LENSES

    MDR report key: 3040150 · Received April 5, 2013

    Report

    Report Number
    MW5029631
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    December 1, 2012
    Report Date
    April 5, 2013
    Manufacturer
    COOOPERVISION
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT ADVERSE REACTIONS TO COOPERVISION PROCLEAR CONTACT LENSES. SHE STATED SHE HAS BEEN WEARING THEM FOR YEARS, BUT THE TWO MOST RECENT BOXES SHE RECEIVED CAUSED EXTREME PAIN IN HER EYES. SHE SAID AFTER A DAY OR TWO OF WEARING THE LENSES, SHE FELT A DEEP PAIN IN HER EYES, HAD BLURRED VISION AND A DISCHARGE COMING OUT OF HER EYES. SHE STATED SHE HAD TO WEAR GLASSES FOR TWO WEEKS. SHE SAID SHE HAS AN ALLERGY TO SILICONE, WHICH IS WHY SHE WEARS THIS BRAND LENSES BECAUSE THEY DO NOT CONTAIN SILICONE. SHE IS CONCERNED WHY SHE IS HAVING SUCH A REACTION TO THESE LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140407 PROCLEAR MULTIFOCAL CONTACT LENSES CONTACT LENSES (BOX 1, LEFT EYE) LPL COOOPERVISION 707482339658
    140408 PROCLEAR MULTIFOCAL CONTACT LENSES CONTACT LENSES (BOX 1, RIGHT EYE) LPL COOPERVISION 707482339610
    140409 PROCLEAR MULTIFOCAL CONTACT LENSES CONTACT LENSES (BOX 2, LEFT EYE) LPL COOPERVISION 707482339658
    140410 PROCLEAR MULTIFOCAL CONTACT LENSES CONTACT LENSES (BOX 2, RIGHT EYE) LPL COOPERVISION 707482339610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other