BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNEREYES CLEARKONE HYBRID CONTACT LENSES

    MDR report key: 2546249 · Received March 12, 2012

    Report

    Report Number
    3005087645-2012-00001
    Event Type
    Injury
    Date Received
    March 12, 2012
    Report Date
    March 8, 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

    ADD'L EXPIRATION DATE: 05/2016. ADD'L MANUFACTURE DATE: 06/2011. THE LENSES HAVE BEEN RETURNED TO THE COMPANY. THE BASE CURVE, AND POWER WERE FOUND TO BE WITHIN SPEC 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 SPEC OF THE LABELED PRODUCT.

    Description of Event or Problem · 1

    THE PRACTICE COMPLETED A PRODUCT RETURN FORM AND STATED THAT THE PT "DEVELOPED EYE INFECTION." A COMPLAINT F/U FORM WAS RETURNED TO THE COMPANY. THE PRACTITIONER STATED THAT THERE WAS A "CORNEAL ULCER RIGHT EYE." FURTHERMORE, THE "PT SOUTH CARE AT ANOTHER INSTITUTION." (B)(4) SPOKE WITH (B)(4) ON (B)(4) 2012. THE PT HAD SURFACE INFECTION THAT WENT DEEP INTO CORNEA. THIS IS AN INJURY. ETIOLOGY PER OD IS UNCLEAR. IT COULD HAVE BEEN SOLUTIONS, CONTACT LENS, OR PT CONTAMINATION - OD DOESN'T KNOW. THE PT WENT TO (B)(4) FOR TREATMENT, OD DOES NOT KNOW IF VISUAL ACUITY WAS AFFECTED. ORIGINAL FIT WAS PERFORMED IN (B)(6) 2011. CAUSE OF INFECTION IS NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNEREYES CLEARKONE HYBRID CONTACT LENSES HYBRID CONTACT LENSES HQD SYNERGEYES, INC. CK25S+0000, CK25S+ 036214,036627

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention