BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3031067 · Received April 2, 2013

    Report

    Report Number
    2648035-2013-00141
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE WAS PRESCRIBED STEROID EYE DROPS POST OPERATIVELY AND WAS QUESTIONING IF HE WAS EXPERIENCING AN ALLERGIC REACTION TO HIS LENSES. HIS EYES FLARE UP AND THERE IS REDNESS AND INFLAMMATION. FURTHER, THE PATIENT INDICATED THAT WHEN HE STOPS TAKING THE DROPS, THE INFLAMMATION REAPPEARS. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST WHO HAS RECOMMENDED A VITRECTOMY. THE PATIENT STATED HE WOULD SEEK A SECOND OPINION. THE PATIENT PROVIDED AN UPDATE ON (B)(6) 2013 WHERE HE STATED THAT HE IS A (B)(6) FROM (B)(6). HE WAS TAKING THE STEROID, DUREZOL, TWICE A DAY AND CHANGED TO STEROID, LOTEMAX. HE WAS NOT TAPERED FROM THE STEROIDS AND QUESTIONS IF HE HAS AN ALLERGIC REACTION TO THE LENSES. HE DID NOT THINK YOU COULD HAVE AN ALLERGIC REACTION TO THE STEROID. HE WENT TO ANOTHER DOCTOR FOR A SECOND OPINION WHO HAS CHANGED HIM TO A DIFFERENT DRUG REGIMEN. THE PATIENT THINKS THAT HE MAY BE ON HIS WAY TO SUCCESS. HE IS GOING TO SEE THE (SECOND OPINION) PHYSICIAN IN SIX WEEKS. A SEPARATE MEDICAL DEVICE REPORT (MDR) IS BEING FILED FOR EACH EYE. THIS MDR IS BEING FILED FOR THE LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134022 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other