BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE UNFOLDER® IMPLANTATION SYSTEM

    MDR report key: 2060403 · Received April 16, 2011

    Report

    Report Number
    2648035-2011-00067
    Event Type
    Injury
    Date Received
    April 16, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. IN FOLLOW-UP WITH THE PHYSICIAN IT WAS LEARNED THE PATIENT RECOVERED WITHOUT PERMANENT INJURY. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. EVALUATION ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSERTION CARTRIDGE WAS DEFORMED AT THE EDGE AND PATIENT ENCOUNTERED A SLIGHT CORNEAL TEAR DURING CATARACT SURGERY WITH INTRAOCULAR LENS(IOL) IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE UNFOLDER® IMPLANTATION SYSTEM IOL INSERTER KYB ABBOTT MEDICAL OPTICS EMERALDC CH01062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other