BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2220757 · Received August 23, 2011

    Report

    Report Number
    2648035-2011-00183
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HALF OF AN INTRAOCULAR LENS WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. ONE DISTORTED HAPTIC ON THE HALF OPTIC WAS OBSERVED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. OUR INVESTIGATION SUGGEST THIS EVENT IS RELATED TO END USER HANDLING AND NOT A DEFICIENT PRODUCT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT FOLLOWING IMPLANT OF THE INTRAOCULAR LENS THE SURGEON NOTED THERE WAS STILL CATARACTOUS MATERIAL IN THE PATIENT'S EYE. WHEN REMOVING THIS MATERIAL, THE CAPSULE TORE AND A VITRECTOMY BECAME NECESSARY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED WITHOUT PATIENT COMPLICATIONS. THE HAPTIC WAS DISTORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention