BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2024372 · Received March 18, 2011

    Report

    Report Number
    2648035-2011-00046
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) HAS NOT BEEN RECEIVED FOR ANALYSIS. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. IN FOLLOW-UP THE ACCOUNT REPORTED THE EVENT WAS NOT RELATED TO THE DEVICE, THE CAUSE OF THIS EVENT WAS USER HANDLING. ALL AVAILABLE INFORMATION IS PROVIDED IN THIS REPORT. NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION, NO DAMAGE WAS OBSERVED TO THE OPTIC OR HAPTICS. A DRIED SUBSTANCE, WHICH APPEARS TO BE VISCOELASTIC, WAS OBSERVED ON THE OPTIC SURFACE. THIS ADVERSE EVENT IS NOT RELATED TO THE DEVICE. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A VITREOUS PROLAPSE DURING CATARACT SURGERY FOR A VERY MATURE CATARACT WITH INTROCULAR LENS IMPLANT. LENS WAS REMOVED AND A VITRECTOMY PERFORMED. THE NURSE STATED THE EVENT WAS NOT RELATED TO THE DEVICE AND WAS A USER HANDLING PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other