BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 4840417 · Received June 11, 2015

    Report

    Report Number
    3006723646-2015-00424
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    March 3, 2015
    Report Date
    June 9, 2015
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004/S
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS FOUND STUCK INSIDE AT THE TOP OF THE INJECTOR TIP. LENS WAS CRACKED. THE SLIDER WAS FULLY ADVANCED AND THE ROD WAS ADVANCED PARTIALLY. TRACE LUBRICANT WAS FOUND INSIDE THE INJECTOR TIP AND ON THE LENS. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PROD. NEW LENS (SAME CONFIGURATION: +17.00D) WAS RE-INSTALLED INSIDE THE REC'D CARTRIDGE AND RELEASED BUT THE LENS CAME OUT WITHOUT ANY PROBLEMS. THE DYE TEST RESULT SHOWS THE INJECTOR TIP WAS PROPERLY COATED. THIS COMPLAINT INVESTIGATION HAS NOT BEEN CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE LENS WOULD NOT ADVANCE THROUGH THE INJECTOR WHEN DOCTOR TRIED TO IMPLANT THE LENS INTO THE PTS EYE. THE LENS DID TOUCH THE EYE BUT WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381444 ISERT ASPHERIC INTRAOCULAR LENS HQL HQL HOYA SURGICAL OPTICS INC. 250

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR