BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNILENS QUANTUM THIN

    MDR report key: 1058152 · Received May 25, 2008

    Report

    Report Number
    1034196-2008-00001
    Event Type
    Other
    Date Received
    May 25, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 23, 2008
    Manufacturer
    UNILENS CORP., USA
    Product Code
    HPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE EXAMINED.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO EYE CARE PRACTITIONER WITH PAIN AND PHOTOPHOBIA IN LEFT EYE ON (B) (6) 2008. DIAGNOSED AS CORNEAL ABRASION CAUSED BY DEFECTIVE CONTACT LENS. PATIENT WAS PROVIDED WITH A HYDROGEL (SOFT) BANDAGE CONTACT LENS. PATIENT WAS SEEN (B) (6) 2008. HEALING WAS PROGRESSING WELL; NEARLY COMPLETE, PROGNOSIS IS COMPLETE RECOVERY WITH ABILITY TO WEAR CONTACTS AGAIN. PATIENT WAS SUBSEQUENTLY REFITTED WITH SOFT CONTACT LENSES SINCE THE ABRASION HEALED COMPLETELY. THE PRIMARY EYE CARE PRACTITIONER INDICATED THE PATIENT IS UNABLE TO EXTRACT CONTACTS FROM EYES WITH FINGERS, AND MUST USE A PLUNGER. THE PRACTITIONER SUSPECTS THE MEANS OF LENS EXTRACTION CONTRIBUTED TO THE INJURY. NO LENS HAS BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNILENS QUANTUM THIN RIGID GAS PERMEABLE CONTACT LENS HPX UNILENS CORP., USA QUANTUM THIN 129601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention