BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3945091 · Received July 18, 2014

    Report

    Report Number
    2648035-2014-00362
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. 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. THE CONDITION OF THE RETURNED LENS WAS CONSISTENT WITH ONE THAT HAS BEEN EXPLANTED. MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. 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 THE PATIENT'S CAPSULE BROKE AFTER INSERTING THE ZA9003 INTRAOCULAR LENS (IOL). THE REPORTER DID NOT KNOW IF A VITRECTOMY WAS REQUIRED OR THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421543 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention