BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3230176 · Received July 16, 2013

    Report

    Report Number
    2648035-2013-00288
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED FOR A VISUAL INSPECTION AT OUR QUALITY ASSURANCE LABORATORY. THE VISUAL INSPECTION REVEALED THAT THE LENS HAD ONE (1) DISTORTED HAPTIC, DEBRIS AND APPEARED TO HAVE EVIDENCE OF VISCOELASTIC.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA SHOULD HAVE BEEN CHECKED AS ''YES'' - LABELED FOR SINGLE USE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT WHILE IMPLANTING AN INTRAOCULAR LENS (IOL) THE PHYSICIAN CHANGED HIS MIND AND AND DECIDED TO REMOVE THE LENS. IN ORDER TO REMOVE THE LENS, HE HAD TO ENLARGE THE INCISION. THE NOTES INDICATED THAT THE REASON FOR THE REMOVAL WAS ''INSERTION ERROR''. NO VITRECTOMY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329778 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention