BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2871007 · Received December 12, 2012

    Report

    Report Number
    9614546-2012-00203
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT DIOPTER POWER FOR THE INTRAOCULAR LENS WAS 19.0 D. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MANUFACTURING RECORD REVIEW SHOWED NO DEVIATIONS, AND THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WAS VERIFIED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTER POWER 20.0 DIOPTER OF THIS LOT NUMBER. IN CONCLUSION, THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED IMPLANT DATE: (B)(6) 2011. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF HALOS WITH ACCOMPANIED "SMEARED" VISION WHILE VIEWING CLOSE OBJECTS. IT WAS STATED THAT THE PATIENT HAD PREVIOUS YAG CAPSULOTOMIES IN BOTH OPTICS WITH MINIMAL IMPROVEMENT. PATIENT REPORTED HAVING THESE SYMPTOMS BEING EXTREMELY DEBILITATING TO HER DAILY ACTIVITIES. IN ADDITION, IT WAS STATED THAT THE PHYSICIAN DOES NOT ATTRIBUTE THESE SYMPTOMS TO THE INTRAOCULAR LENS (IOL). THE LENS REMAINS IMPLANTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other