BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 3822208 · Received May 20, 2014

    Report

    Report Number
    2648035-2014-00259
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 13, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THE PRELOADED ASSEMBLY RECORD WAS REVIEWED. NO DEVIATIONS RELATED TO THE PRELOADED INSERTER SYSTEM WERE REPORTED. THE RESULTS OF THE LUBRICITY TESTS PERFORMED IN THIS PRODUCTION ORDER WERE FOUND WITHIN SPECIFICATIONS. A REVIEW OF PROCESS MANUFACTURING INSTRUCTIONS IN CHANGE CONTROL SYSTEM WAS DONE DURING THE PERIOD WHEN THIS PRODUCT WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD OR SPECIFICATIONS THAT COULD BE RELATED FOR THIS COMPLAINT TYPE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED THAT LENS WAS NOT FOUND INSIDE. PRELOADED INSERTION SYSTEM WAS FOUND TO BE USED WITH CARTRIDGE OBSERVED IN THE CORRECT POSITION, FULLY ENGAGED INTO LOWER BODY OF THE PCB00 DEVICE. RESIDUES OF VISCOELASTIC SOLUTION WERE OBSERVED ON CARTRIDGE TUBE AND LOADING ZONE AREA. STRETCH MARKS WERE OBSERVED IN THE CARTRIDGE TUBE AND TIP OF RETURNED SAMPLE. TIP CONDITION WAS OBSERVED TO BE DEFORMED. LENS WAS NOT RECEIVED FOR EVALUATION. NO FURTHER INVESTIGATION WAS CONDUCTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A CRACK WAS DISCOVERED IN THE IOL. AS A RESULT, THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS. DURING THE PROCEDURE, THE INCISION WAS ENLARGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IN ADDITION, THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299413 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention