BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1903390 · Received November 19, 2010

    Report

    Report Number
    2648035-2010-00228
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT STATED THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED ON (B)(6) 2010 WITHOUT COMPLICATION. THE CAUSE OF THE IOL EXPLANT WAS SIGNIFICANT REFRACTIVE ERROR. THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, [(B)(4) THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS ASSOCIATED WITH THIS EVENT. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. PATIENT OUTCOME WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION. REASON STATED WAS THE SIGNIFICANT REFRACTIVE ERROR. THE SURGEON STATED THE LIKELY REASON FOR THE ERROR WAS THE EYE'S AXIAL LENGTH OR OTHER FACTORS.

    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 Required Intervention