BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1970545 · Received January 25, 2011

    Report

    Report Number
    2648035-2010-00271
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. BOTH SURFACES WERE COVERED WITH DRIED MATERIAL, NOT INCONSISTENT WITH A LENS THAT WAS EXPLANTED. THE OPTIC WAS CLEANED AND REINSPECTED, NO OPTICAL DEFECTS WERE FOUND. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THE IOL WAS NOT YET RECEIVED BY THE MANUFACTURER FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL INFORMATION CURRENTLY AVAILABLE WAS INCLUDED IN THIS REPORT. AN UPDATE TO THIS MDR WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL REPORTABLE INFORMATION. DEVICE NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION DUE TO THE PATIENT'S COMPLAINT OF EDGE GLARE. AN ALTERNATE LENS OF A LOWER DIOPTER WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention