BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2071264 · Received April 27, 2011

    Report

    Report Number
    2648035-2011-00076
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P98040/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    ONE HALF OF THE INTRAOCULAR LENS WAS RECEIVED AND INSPECTED UNDER 10X MAGNIFICATION. INSPECTION SHOWS ONE BROKEN HAPTIC, 1/2 AN OPTIC. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE CAUSE OF THIS EVENT WAS NOT CONFIRMED BUT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT THE PATIENT'S POSTERIOR CAPSULE TORE. THE CUSTOMER STATED THERE WAS NO INJURY AND THE INCISION WAS NOT ENLARGED TO REMOVE THE LENS. DUE TO THE CAPSULAR TEAR AN ANTERIOR CHAMBER LENS WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention