BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1900743 · Received November 16, 2010

    Report

    Report Number
    2648035-2010-00223
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND IS CURRENTLY BEING ANALYZED AT THE MANUFACTURING SITE. THE PATIENT'S INITIAL IMPLANT WAS REPLACED WITH A HIGHER DIOPTER IOL, SUGGESTING THE IOL WAS NOT THE CAUSE OF THIS EVENT. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS MEASURED FOR POWER AND WAS CORRECT AS LABELED, 18.5 DIOPTERS. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 3 MONTHS AFTER IMPLANT. REASON STATED WAS, THE WRONG IOL POWER WAS IMPLANTED, NO PATIENT INJURY..

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ACTUAL PATIENT RESULTS WERE NOT SUPPLIED. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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