BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3223058 · Received July 12, 2013

    Report

    Report Number
    2648035-2013-00281
    Event Type
    Injury
    Date Received
    July 12, 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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    . ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED BOTH OF HIS EYES "FOGGED UP" WHEN HE WALKED BACK IN HIS HOUSE AFTER WALKING HIS DOG IN SINGLE DIGIT WEATHER. IN ADDITION, IT WAS REPORTED THAT THE EDGES OF HIS VISION ARE SHARP BUT THE CENTER APPEARS DIFFUSED. HIS OPTIMUM FIELD OF VISION IS BETWEEN 3 TO 15 FEET. THEREFORE, WHEN DRIVING, HE CANNOT PASS CARS AS HE CANNOT SEE IF A CAR IS COMING IN THE OPPOSITE DIRECTION. PER PATIENT, HE HAS SEEN SEVERAL DOCTORS WHO HAVE INFORMED HIM THAT THE (LENS IMPLANT) PROCEDURE WAS DONE WELL AND HIS SYMPTOMS MIGHT RESOLVE ONE DAY. IT WAS STATED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF VASELINE/WAXY VISION ACCOMPANIED BY VISUAL DISTURBANCES AND A DECREASE IN INTERMEDIATE VISION. PATIENT WAS INFORMED THAT AMO HAD PREVIOUSLY SPOKE WITH HIS DOCTOR, WHO INDICATED SHE DID NOT ATTRIBUTE THE PATIENT'S SYMPTOMS TO THE PRODUCT. THE PATIENT AGREED AND STATED THAT HE FOLLOWED UP WITH HIS DOCTOR WHO TOLD HIM THE SAME THING. FURTHERMORE, THE PATIENT WAS SEEN BY HIS OPTOMETRIST WHO ALSO CONFIRMED THE LENS WAS POSITIONED ACCURATELY, AND IS WORKING APPROPRIATELY. PATIENT'S INQUIRY WAS ADDRESSED CONCERNING "WHY THE LENSES FOGGED-UP" AND IT WAS STATED THAT THE INTRAOCULAR LENSES ARE PLACED IN THE CAPSULAR BAG INSIDE HIS OPTIC AND DO NOT HAVE EXPOSURE TO OUTSIDE ENVIRONMENTAL EFFECTS. FURTHERMORE, IT WAS RECOMMENDED THAT THE PATIENT FOLLOW-UP WITH HIS HEALTH CARE PROFESSIONALS REGARDING ANY CONSULTATION/TREATMENT OPTIONS. PATIENT WAS PLEASED AND INFORMED AMO THAT HE WILL FOLLOW-UP WITH HIS PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED. PRESENT MEDICATIONS RESTASIS FOR DRY EYE SYMPTOMS AND PRAVASTATIN, ANTI-PRESSURE MEDICATION. (B)(4). THE MANUFACTURING RECORDS WERE REVIEWED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. CORRECTED DATA: 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

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A CONSUMER WHO INDICATED THAT HE IS EXPERIENCING DIFFICULTY WITH ''DIFFUSION OF IMAGES, INADEQUATE DISTANCE VISION AND UNABLE TO DISTINGUISH FINE LINES AND SMALL IMAGES.'' THE POOR VISUAL ACUITY AFFECTS THE PATIENT'S DAILY ACTIVITIES. THE LENSES HAVE BEEN IMPLANTED LONGER THAN (3) THREE MONTHS. THIS REPORT IS FOR THE LEFT EYE. A SEPARATE MDR IS BEING FILED FOR THE PATIENT'S OTHER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322135 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other