BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1904802 · Received November 22, 2010

    Report

    Report Number
    2648035-2010-00229
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED FOR ANALYSIS AND SHOWED ONE DISTORTED HAPTIC. SURGEON STATED THE CAUSE OF THE DISLOCATION WAS MOST LIKELY A DAMAGED HAPTIC DURING IMPLANT. WE HAVE NO REASON TO SUSPECT THIS EVENT IS RELATED TO THE MANUFACTURING PROCESS.ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS IMPLANTED AND REMOVED 2 WEEKS LATER, DUE TO A DISLOCATION. THE PHYSICIAN REPLACED THE LENS WITH NO FURTHER COMPLICATIONS.

    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 Required Intervention