BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE UNFOLDER® IMPLANTATION SYSTEM

    MDR report key: 2072194 · Received April 28, 2011

    Report

    Report Number
    2648035-2011-00078
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K961242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND IS CURRENTLY BEING EVALUATED. PRIOR TO RELEASE TO THE MARKET THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE TO DATE BEEN UNSUCCESSFUL. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE RETURNED CARTRIDGE WAS OBSERVED WITH A HEAVY DENT AT THE TIP SECTION. A STRESS MARK WAS OBSERVED ON BOTH SIDES OF THE CARTRIDGE TUBE. VISCOELASTIC RESIDUES WERE DETECTED INSIDE THE TUBE SECTION. THE UNIT CAN BE DETECTED WITH UNAIDED EYE DURING THE VISUAL INSPECTION BY THE OPERATOR. THE INNER TRAY WAS DESIGNED TO PROTECT CARTRIDGES FOR TIP DEFECTS DURING PACKAGING AND SHIPPING. THE MANUFACTURING OPERATORS ARE PROPERLY TRAINED TO REJECT THE CARTRIDGES IF ANY TIP DEFECTS ARE DETECTED. THE DEFORMED TIP CONDITION SHOWED ON THE COMPLAINT UNIT RECEIVED CANNOT BE DUPLICATED. NO PROCESS STEP IN THE MANUFACTURING WAS IDENTIFIED AS GENERATING THIS TYPE OF COMPLAINT. THE MANUFACTURING RECORD WAS REVIEWED AND DOES NOT HAVE ANY DEVIATION TO THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THIS COMPLAINT DESCRIPTION. ALL CARTRIDGES WERE MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED TO AN AMO REPRESENTATIVE THAT THE INSERTION CARTRIDGE HAD A DEFORMED TIP WHICH DAMAGED THE OPTIC OF THE INTRAOCULAR LENS AND RIPPED THE DESCEMET'S MEMBRANE AT THE SIDE OF THE INCISION. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE UNFOLDER® IMPLANTATION SYSTEM IOL INSERTER KYB ABBOTT MEDICAL OPTICS EMERALDC CH00842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other