BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3211347 · Received July 8, 2013

    Report

    Report Number
    9614546-2013-00113
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE THAT NO EXPLANT HAS BEEN PLANNED. THE PATIENT HAD MICRO-KERATITIS ON A VERY DRY EYE, BUT DOES NOT HAVE THE PROBLEM ANYMORE. THE PATIENT HAS SOME GLARE IN THE NIGHT ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE OF EVENT - THE ACTUAL DATE OF EVENT WAS NOT PROVIDED; HOWEVER, IT WAS STATED THAT THE EVENT WAS IN THE NEXT DAYS AFTER SURGERY. SURGERY DATE WAS (B)(6) 2013 IN THE PATIENT'S LEFT EYE. DESCRIBE EVENT: ADDITIONAL INFORMATION STATES: MAYBE MORE IN LEFT EYE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES: MEDICATION: TOBRADEX 5X/D IN THE PATIENT'S LEFT EYE, DATE(S) NOT PROVIDED. RELEVANT HISTORY: PATIENT NOTED TO HAVE MICRO KERATITIS. THE SERIAL NUMBER OF THE INTRAOCULAR LENS IS UNKNOWN, THUS THE EXPIRATION DATE IS ALSO UNKNOWN. THE SERIAL NUMBER OF THE INTRAOCULAR LENS IS UNKNOWN, THUS THE MANUFACTURE DATE OF THE LENS IS UNKNOWN. ADDITIONAL INFORMATION: THE DOCTOR REPORTED THAT EVERYTHING WAS FINE NOW, THE PATIENT DOESN¿T HAVE THE PROBLEM SHE HAD PREVIOUSLY. PATIENT HAD THIS LITTLE MICRO-KERATITIS ON A VERY DRY EYE THAT MAY BE WHY SHE HAD THE PROBLEM. PATIENT HAS JUST SOME GLARE AT NIGHT NOW. THESE GLARES SHOULD DECREASE. REASON FOR NON EVALUATION: TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHO IS EXPERIENCING SEVERE PHOTOPHOBIA THAT IMPACTS HER DAILY ACTIVITIES, AFTER AN INTRAOCULAR LENS WAS IMPLANTED IN HER EYE. THE REPORTER INDICATED THAT THE PATIENT MUST STAY IN A DARKENED ROOM AND WEAR SUNGLASSES; SHE IS NOT ABLE TO DRIVE DURING THE DAY. AT THIS TIME THE LENS REMAINS IMPLANTED. THE PATIENT WAS TREATED WITH DEXAFREE, AERIUS, LARCYCON AND PILOCARPINE 2%. A SEPARATE MDR IS BEING SUBMITTED FOR EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310116 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other