BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2063609 · Received April 19, 2011

    Report

    Report Number
    2648035-2011-00071
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. TWO DETACHED HAPTICS WERE OBSERVED, NOT INCONSISTENT WITH AN EXPLANTED LENS. THE LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE IOL HAS NOT BEEN RECEIVED FOR ANALYSIS. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. THE ACCOUNT STATED THERE WAS NO PROBLEM WITH THE LENS AND THE EVENT WAS PATIENT RELATED. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A DIFFICULT CASE THE SURGEON ATTEMPTED TO PLACE AND SUTURE AN INTRAOCULAR LENS(IOL) IN A PATIENT WITH A NON-INTACT CAPSULAR BAG ASSOCIATED WITH A PREVIOUS SURGERY. THE IOL FELL TO THE RETINA, IT WAS REMOVED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. ACCOUNT STATED THERE WAS NO PROBLEM WITH THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention