BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3130730 · Received May 24, 2013

    Report

    Report Number
    2648035-2013-00233
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE IOL WAS RETURNED TO THE MANUFACTURER. THE LENS HAD ONE DISTORTED HAPTIC, A TORN OPTIC, THE LENS WAS PARTIALLY FOLDED AND APPEARS TO HAVE EVIDENCE OF OPHTHALMIC VISCOELASTIC.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT REGARDING A PATIENT WHO HAD AN INTRAOCULAR LENS IMPLANTED. ONCE THE LENS WAS IN THE EYE, THE DOCTOR DID NOT LIKE THE WAY THE LENS WAS SITTING IN THE EYE AND REMOVED; HE SUBSEQUENTLY PERFORMED A VITRECTOMY. ANOTHER LENS WAS IMPLANTED DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231903 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention