BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4233346 · Received November 6, 2014

    Report

    Report Number
    2648035-2014-00591
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND WAS RECEIVED CUT INTO PIECES. THE LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED THAT SOME SCRATCHES WERE OBSERVED. A SUBSTANCE THAT APPEARS TO BE VISCOELASTIC (OVD) WAS OBSERVED ON THE LENS. IN ADDITION THE VISUAL INSPECTION REVEALED A FEW SURFACE RESIDUALS ON THE LENS. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS (IOL) WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM PRODUCT GENERATION TO PRODUCT 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'S REPORT WAS GENERATED. A REVIEW OF THE RAW MATERIAL/MANUFACTURING PROCEDURES WAS DONE DURING THE PERIOD WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE THAT WAS RELATED TO THE COMPLAINT REPORTED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTING THE INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE, PHYSICIAN NOTED A SCRATCH ON THE LENS. LENS WAS CUT WITH LENS CUTTERS, INCISION WAS ENLARGED AND LENS WAS REMOVED. ANOTHER LENS OF THE SAME DIOPTER WAS PLACED. REPLACEMENT LENS MODEL AND SERIAL NUMBER WAS NOT PROVIDED. VITRECTOMY WAS NOT PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS NOTED TO HAVE RECOVERED AND OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713340 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention PLATINUM CARTRIDGE 1MTEC30, LOT UNKNOWN