BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES PS HYBRID CONTACT LENSES

    MDR report key: 2599142 · Received May 17, 2012

    Report

    Report Number
    3005087645-2012-00002
    Event Type
    Injury
    Date Received
    May 17, 2012
    Report Date
    May 14, 2012
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENSES HAVE BEEN RETURNED TO THE COMPANY. THE BASE CURVE AND POWER WERE FOUND TO BE WITHIN SPECIFICATION OF THE LABELED PART NUMBER. THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE LOT OF LENSES MANUFACTURED AND THE PRODUCTS WERE FOUND TO BE WITHIN SPECIFICATION OF THE LABELED PRODUCT.

    Description of Event or Problem · 1

    THE PRACTICE COMPLETED A PRODUCT RETURN FORM AND STATED THAT THE "PT HAS HAD CHRONIC EYE INFECTIONS SINCE THE PURCHASE OF THESE LENSES." A COMPLAINT FOLLOW-UP FORM WAS FAXED, REFAXED, AND (B)(6) TO THE PRACTICE WITH NO RESPONSE. (B)(6) TRIED TO CONTACT THE PRACTITIONER WITH REGARDS TO MORE INFO BUT THE PRACTICE NEVER CONTACTED THE COMPANY BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGEYES PS HYBRID CONTACT LENSES HYBRID CONTACT LENSES HQD SYNERGEYES, INC. PS8486-0300L2, PS8 040221, 039736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention