BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3891990 · Received June 24, 2014

    Report

    Report Number
    9614546-2014-00163
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF REPOSITION IS UNKNOWN. EXPLANT DATE: N/A; DEVICE REMAINS IMPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2014. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AFTER AN ZCT TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, HIS VISUAL ACUITY WAS LIMITED TO 20/80. THE SURGEON NOTED THAT HE WAS UNABLE TO VERIFY THE POSITION OF THE IOL DUE TO THE PATIENT'S MIOSIS. IN FOLLOW UP IT WAS LEARNED THAT THE IOL WAS RE-POSITIONED AND THE PATIENT IS VERY HAPPY WITH HIS VISUAL ACUITY. THE INITIAL POSITIONING OF THE IOL WAS INCORRECT DUE TO A CALCULATION ERROR BY THE SURGEON. THE DATE THE IOL WAS REPOSITIONED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368394 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention