BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3944534 · Received July 18, 2014

    Report

    Report Number
    2648035-2014-00356
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 29, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PATIENT HAS NO COMPLAINTS, POST-OPERATIVELY. DEVICE EVALUATION: THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER 10X MICROSCOPE MAGNIFICATION. THE LENS WAS RECEIVED WITH A DETACHED HAPTIC. HAPTIC WAS NOT RETURNED. VISUAL INSPECTION REVEALED SURFACE SCRATCHES ON THE LENS, A CRACK IN THE OPTIC ZONE AND SURFACE RESIDUALS (FIBER/ PARTICLES) ON THE LENS, WHICH IS CONSISTENT WITH THE LENS BEING HANDLED AND HANDLED OUT OF A STERILE ENVIRONMENT. DUE TO THE RETURNED CONDITION OF THE SAMPLE, NO FURTHER INVESTIGATION WAS PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. A REVIEW OF THE MANUFACTURING PROCESS AND/OR MATERIALS SHOW THERE WERE NO CHANGES IN MANUFACTURING ASSOCIATED WITH THIS PRODUCTION ORDER. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) HAD BEEN INSERTED INTO PATIENT¿S LEFT EYE, CAPSULE TEAR WAS NOTED. VITRECTOMY WAS PERFORMED BUT INCISION WAS NOT ENLARGED. A REPLACEMENT LENS OF A DIFFERENT MODEL WAS PLACED SUCCESSFULLY. PATIENT OUTCOME WAS ASKED BUT NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423393 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PLATINUM CARTRIDGE MODEL 1MTEC30, LOT # UNKNOWN