BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES SILICONE HYDROGEL HYBRID CONTACT LENSES

    MDR report key: 2599105 · Received May 22, 2012

    Report

    Report Number
    3005087645-2012-00003
    Event Type
    Injury
    Date Received
    May 22, 2012
    Report Date
    May 14, 2012
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    THE PRACTICE COMPLETED A PRODUCT RETURN FORM AND STATED THAT THE PT HAD AN "ADVERSE REACTION." ON (B)(6) 2012 THE QC SUPERVISOR CONTACTED THE PRACTICE AND WAS ABLE TO SPEAK WITH DR. (B)(6). DR. (B)(6) DESCRIBED HIS FITTING OF THE CONTACT LENSES WITH THE PT. THE PT WAS UNCOMFORTABLE DURING FITTING, HE STARTED WITH MEDIUM, AND REPLACED WITH A FLAT SKIRT. A CORNEAL ULCER WAS OBSERVED AFTER TWO WEEKS OF FITTING. THE CORNEAL SHOWED SIGNS OF THINNING. CORNEAL STAINING WAS ALSO OBSERVED. THE ISSUES APPEARED TO CLEAR WITHIN 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGEYES SILICONE HYDROGEL HYBRID CONTACT LENSES HYBRID CONTACT LENSES HQD SYNERGEYES, INC. SA73F-0525 042332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention