BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4182584 · Received October 17, 2014

    Report

    Report Number
    2648035-2014-00553
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE OR DATE OF BIRTH AND GENDER: ASKED BUT UNAVAILABLE (ASKU). INITIAL REPORTER PHONE NUMBER: (B)(6). (B)(4),. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MEDICAL DEVICE REPORT: DEVICE RETURNED TO MANUFACTURER 10/16/2014 (CORRECTED DATE). DEVICE EVALUATION: THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATION. A PRELOADED INSERTION SYSTEM AND A LOOSE LENS WERE RECEIVED. THE LENS HAD ONE HAPTIC DETACHED. THE PRELOADED INSERTION SYSTEM WAS OBSERVED AND HAD WHAT APPEARED TO BE VISCOELASTIC RESIDUE AT THE CARTRIDGE TIP. ALSO STRESS MARKS WERE OBSERVED BETWEEN THE CARTRIDGE TUBE AND TIP. THE PLUNGER COMPONENT WAS OBSERVED IN A FULLY ADVANCED POSITION WITH THE PUSHROD RIGHT IN THE EDGE BORDER OF THE CARTRIDGE TIP. THE LENS HAPTIC WAS OBSERVED STUCK IN THE CARTRIDGE WITH PART OF THE HAPTIC OUT OF THE CARTRIDGE TIP. THE PUSHROD WAS OBSERVED, WHICH OVERRODE THE HAPTIC. THE CARTRIDGE WAS OBSERVED IN THE CORRECT POSITION (FULLY ENGAGED INTO LOWER BODY OF THE PCB00V DEVICE). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING RECORD REVIEW INDICATED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. 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 DOES NOT SHOW ANY CHANGE IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS THAT COULD BE RELATED WITH THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWS THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE AMO SALES REPRESENTATIVE THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), ONE OF THE HAPTIC BROKE. IT WAS NOTED THE BROKEN HAPTIC WAS FOUND AFTER LENS WAS PLACED IN THE PATIENT'S EYE. LENS WAS REMOVED WITH AN INCISION ENLARGEMENT FROM 2.8MM TO 6.0MM. A REPLACEMENT LENS WAS PLACED IN THE SAME PROCEDURE. REPLACEMENT LENS WAS A NON-AMO LENS. NO PATIENT COMPLICATIONS WERE REPORTED. ALSO, IT WAS NOTED THAT NO ADDITIONAL PROCEDURES WERE PERFORMED AND THE EVENT DID NOT HAVE AN IMPACT ON THE PATIENT'S VISUAL ACUITY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660838 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention