BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POST-SURGICAL HYBRID CONTACT LENSES

    MDR report key: 2452815 · Received April 9, 2010

    Report

    Report Number
    3005087645-2010-00001
    Event Type
    Injury
    Date Received
    April 9, 2010
    Report Date
    April 8, 2010
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K060102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONE LENS CONTAINED IN THE VIAL PASSED BASE CURVE, POWER, AND SURFACE INSPECTION. THERE APPEARS TO BE A PRE-EXISTING HISTORY OF CORNEAL REJECTION PRIOR TO SYNERGEYES, INC CONTACT LENS WEAR FROM PRACTITIONER'S INFORMATION. THE DEVICE HISTORY RECORD DEMONSTRATED THAT THERE WAS NO NON-CONFORMITIES FOUND THAT COULD LEAD THE FIELD EVENT.

    Description of Event or Problem · 1

    THE PRACTITIONER STATED THAT THE PATIENT HAD A CORNEAL TRANSPLANT (GRAF) OR "PKP (PENETRATING KERPLASTY) OS. [THE PATIENT] WORE LENS FOR 6 WEEKS, STATING EPISODE OF CORNEAL REJECTION." THE PATIENT REQUIRED MEDICAL INTERVENTION AS STATED BY THE PRACTITIONER. THE PATIENT WAS "CURRENTLY BEING TREATED AT ATTENDING SURGEON'S OFFICE." THE PATIENT HAD "PKP SURGERY IN 1995 OS. HE HAS HAD 2 PRIOR EPISODES OF REJECTION ON OS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST-SURGICAL HYBRID CONTACT LENSES CONTACT LENS HQD SYNERGEYES, INC. PS - POST SURGICAL 027766

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention