BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3945211 · Received July 18, 2014

    Report

    Report Number
    9614546-2014-00181
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: OTHER RELEVANT HISTORY: ADDED DEPRESSION OF THE PATIENT. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ASKED BUT NOT PROVIDED. COMMON DEVICE NAME: CODE - SERIAL NUMBER WAS NOT PROVIDED, UNKNOWN IF LENS IS MULTIFOCAL OR MONOFOCAL LENS. MODEL NUMBER: UNKNOWN, CATALOG NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN, SERIAL NUMBER: ASKED BUT NOT PROVIDED. IF EXPLANTED, GIVE DATE: ASKED BUT UNKNOWN IF LENS HAS BEEN EXPLANTED. PMA/510(K) NUMBER: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THAT SHE HAS BEEN EXPERIENCING FLICKERS AND SHIMMERS (DYSPHOTOPSIA). ADDITIONALLY, PATIENT REPORTED RIGHT EYE WAS IMPLANTED WITH INTRAOCULAR LENS (IOL) DIOPTER 10.0 ON (B)(6) 2014. PATIENT FURTHER STATED SHE WAS PRESCRIBED ALPHAGEN WHICH IMPROVED HER VISION BUT GAVE HER AN INTENSE HEADACHE, AND AFTER DISCONTINUING ALPHAGEN, EYE FLICKERS WERE HAPPENING MUCH MORE OFTEN AND SHE BEGAN TO SEE FLASHES. PATIENT NOTED FLICKERS HAVE GOTTEN WORSE, UNDER ANY KIND OF LIGHT, AND HAVE CAUSED HER TO SLIP INTO DEPRESSION. PATIENT CONTINUED THAT SHE HAS CONSULTED WITH FOUR (4) OTHER DOCTORS AND ALL ATTRIBUTE THE DYSPHOTOPSIA TO THE FACT THAT ONE EYE HAS A 1-PIECE MODEL LENS AND THE OTHER EYE HAS A 3-PIECE MODEL LENS. PATIENT STATED SHE IS HIGHLY MYOPIC. NO FURTHER INFORMATION HAS BEEN PROVIDED. COMPANION EYE WILL BE SUBMITTED IN A SEPARATE EMDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422205 TECNIS TORIC IOLS MJP ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other