BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4111762 · Received September 23, 2014

    Report

    Report Number
    2648035-2014-00498
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    May 21, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION REVEALED THAT THE LENS WAS CUT OFF IN HALF. A SUBSTANCE THAT APPEARS TO BE VISCOELASTIC (OVD) WAS OBSERVED IN THE SAMPLE. ALSO, THE VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBER/PARTICLES) ON THE LENS COMPATIBLE WITH HANDLING THE LENS NON-STERILE ENVIRONMENT. NO COSMETIC DEFECTS RELATED TO MANUFACTURING WERE FOUND IN THE RETURNED LENS. MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AFTER IMPLANTING A ZCB0000205 INTRAOCULAR LENS (IOL) THE SURGEON USED AN ORA ABERROMETER. THE READINGS OBTAINED SUGGESTED USING A DIFFERENT DIOPTER POWER. THE INCISION WAS ENLARGED AND THE IOL CUT OUT. AN EXCHANGE WAS PERFORMED DURING THE SAME PROCEDURE. THE REPORT INDICATED THE PATIENT HAS RECOVERED. THERE WERE NO QUALITY ISSUES WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591460 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention