BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3253355 · Received July 29, 2013

    Report

    Report Number
    9614546-2013-00127
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DIOPTER MEASUREMENT RECORDS WERE VERIFIED AND WERE SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 16.0 DIOPTER FOR THIS SERIAL NUMBER. A REVIEW OF THE HISTORICAL COMPLAINT DATA REVEALED THAT NO COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING SITE. THE VISUAL INSPECTION SHOWED THAT THE RETURNED LENS WAS CUT IN TWO (2) PIECES. THE LENS WAS IDENTIFIED AS A TECNIS MULTIFOCAL ACRYLIC 3-PIECE INTRAOCULAR LENS DUE TO THE PRESENCE OF RINGS ON THE OPTIC SURFACE AND THE TYPE OF HAPTICS. FURTHER ANALYSIS ON THE LENS WAS NOT POSSIBLE DUE TO THE FACT THAT THE LENS WAS RECEIVED DAMAGED. THE INVESTIGATION OF THE RETURNED SAMPLE LENS SHOWED NO COMPLAINT RELATED NON CONFORMANCES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A FEMALE CONSUMER REPORTED THAT AFTER HAVING AN INTRAOCULAR LENS IMPLANTED IN THE RIGHT EYE, SHE EXPERIENCED SYMPTOMS OF HALOS AND GLARE AT NIGHT, CAUSING AN INABILITY TO DRIVE AT NIGHT. SHE TRIED CONTACT LENSES IN THE LEFT EYE TO IMPROVE VISION BUT WITHOUT SUCCESS. IN FOLLOW UP WITH THE PATIENT''S SURGEON IT WAS LEARNED THAT THE INTRAOCULAR LENS WAS EXPLANTED, A VITRECTOMY WAS REQUIRED AND A MONOFOCAL ANTERIOR CHAMBER LENS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354042 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention