BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3930421 · Received July 11, 2014

    Report

    Report Number
    2648035-2014-00340
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS RETURNED TO THE MANUFACTURER AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION, WHICH IS OUR NORMAL INSPECTION MAGNIFICATION. VISUAL INSPECTION REVEALED THAT LENS WAS CUT NEAR THE LENS CENTER, AND ONE HAPTIC WAS DETACHED. IN ADDITION 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. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT'S EYE. THE RETURNED SAMPLE WAS TESTABLE FOR VISUAL INSPECTION ONLY. DUE TO THE RETURNED CONDITION OF THE LENS, DIMENSIONAL TESTING COULD NOT BE PERFORMED. THE MANUFACTURING RECORD REVIEW ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE DESIGNATED COMPLAINT TYPES WERE GENERATED. A REVIEW OF THE RAW MATERIAL/MANUFACTURING PROCEDURES IN THE CHANGE CONTROL SYSTEM WAS DONE DURING THE PERIOD WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS THAT COULD BE RELATED TO THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT OF LENS IN A SECONDARY PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE OWING TO A DISLOCATED IOL. IT WAS STATED THAT AN AQ2010V (STAAR LENS) WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406315 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention