BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNIS ACRYLIC

    MDR report key: 1073645 · Received July 8, 2008

    Report

    Report Number
    2648035-2008-00033
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS DISCARDED BY THE SURGERY CENTER. PRODUCT HISTORY RECORDS INDICATE THE LENS MET ALL CRITERIA PRIOR TO RELEASE. WHILE THE MANUFACTURER WAS UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE IDENTIFIED, OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. IT IS UNKNOWN WHETHER THERE IS A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT. THE MANUFACTURER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS HAPTIC BENT DURING INSERTION AND THE IRIS PROLAPSED. THE DAMAGED LENS WAS REMOVED AND A SECOND LENS IMPLANTED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNIS ACRYLIC INTRAOCULAR LENS HQL ADVANCED MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention