BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 3945185 · Received July 18, 2014

    Report

    Report Number
    2648035-2014-00363
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THAT SHE HAS BEEN EXPERIENCING FLICKERS AND SHIMMERS (DYSPHOTOPSIA). ADDITIONALLY, PATIENT REPORTED LEFT EYE WAS IMPLANTED WITH INTRAOCULAR LENS (IOL) DIOPTER 6.0 ON (B)(6) 2014 AND LIMBAL RELAXATION INCISION WAS DONE. 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. ALSO, PATIENT ADDED THAT HER ORIGINAL DOCTOR, DR. (B)(6) OF (B)(6) CENTRE, WANTS TO DO AN EXPLANT OF IOL TO CHANGE TO A 1-PIECE MODEL; HOWEVER, THE FOUR (4) OTHER DOCTORS, WHICH THE PATIENT HAS CONSULTED WITH, ADVISE PATIENT AGAINST THIS, DUE TO PATIENT RISK. 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
    422980 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other