BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4123756 · Received September 26, 2014

    Report

    Report Number
    2648035-2014-00508
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION UNDER 10X MICROSCOPE MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT IN HALVES. THE LENS CONDITION COULD BE ASSOCIATED WITH THE EXPLANT PROCESS. NO FURTHER ANALYSIS WAS POSSIBLE DUE TO THE CONDITION OF THE RETURNED LENS. THE REPORTED EVENT COULD BE RELATED TO A COMPLICATION OF THE SURGICAL PROCEDURE RELATED TO PATIENT FACTORS. BASED ON THE CONDITION OF THE RETURNED LENS, RESULTS CODE FOR OPERATIONAL WAS CHOSEN. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. NO DEVIATION OR NON-CONFORMANCE REPORT (NCR) RELATED TO THE CUSTOMER'S REPORT WAS GENERATED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ALCON MONARCH II INSERTER WITH ALCON C CARTRIDGE, LOT UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, WHEN PHYSICIAN NOTICED A TEAR IN THE PATIENT¿S CAPSULE. LENS WAS REMOVED AND CAPSULE ISSUE WAS REPAIRED. INCISION WAS ENLARGED BUT VITRECTOMY WAS NOT PERFORMED. A REPLACEMENT LENS WAS THEN IMPLANTED SUCCESSFULLY. REPLACEMENT LENS WAS OF THE SAME MODEL (ZCB00), BUT DIOPTER AND SERIAL NUMBER WERE NO PROVIDED. PATIENT WAS NOTED TO HAVE RECOVERED AND OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602421 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention