BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE UNFOLDER IMPLANTATION SYSTEM

    MDR report key: 2072167 · Received April 28, 2011

    Report

    Report Number
    2648035-2011-00079
    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 NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. 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

    A SUPPLEMENT MDR IS BEING SUBMITTED TO INDICATE THAT THERE WERE TWO CARTRIDGES INSTEAD OF ONE REPORTED. THE PHYSICIAN REPORTED TO AN AMO REPRESENTATIVE THAT THERE WERE TWO INSERTION CARTRIDGES FROM LOT NO. CH00211 THAT HAD DEFORMED TIPS WHICH DAMAGED THE OPTIC OF THE INTRAOCULAR LENS AND RIPPED THE DESCEMET''S MEMBRANE AT THE SITE OF THE INCISION. NO FURTHER DETAILS WERE REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. PRIOR TO RELEASE TO THE MARKET THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A PREVIOUSLY SUBMITTED CORRECTION (MDR# 2648035-2011-00079) WAS FILED TO CORRECT MDR# 2648035-2011-00078 FILED WITH LOT# CH00211 BECAUSE OF AN INCORRECT MDR NUMBER. THE ORIGINAL REPORT WITH MDR# 2648035-2011-00078, LOT# CH00842 IS CORRECT.

    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.

    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 CH00211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other