BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1871945 · Received October 16, 2010

    Report

    Report Number
    9614546-2010-00053
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL WAS NOT RETURNED TO THE MANUFACTURER. IN FOLLOW-UP WITH THE INITIAL IMPLANT PHYSICIAN HE STATED THERE WAS NO ISSUE WITH THE PATIENT'S IOLS, PATIENT WAS NOT ABLE TO NEUROADAPT TO THE MULTIFOCALITY OF THE LENSES. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO ADDITIONAL REPORTS OF A SIMILAR NATURE WERE RECEIVED ON REMAINING IOLS MANUFACTURED IN THIS LOT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE RECEIVED A LETTER FROM A PATIENT IN WHOM HE HAD IMPLANTED BILATERAL MULTIFOCAL INTRAOCULAR LENSES(IOLS) IN (B)(6) 2010. SHE REPORTED THAT SHE HAD THE LENSES REMOVED AND REPLACED WITH MONOFOCAL LENSES BY AN UNIDENTIFIED PHYSICIAN DUE TO HER BLURRY AND DOUBLE VISION. PRECISE DATES OF THE EXPLANTS ARE UNKNOWN AND NO IDENTIFIERS WERE RECEIVED FOR THE REPLACEMENT IOLS. THIS IS THE FIRST OF 2 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention