BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 3973360 · Received August 1, 2014

    Report

    Report Number
    2648035-2014-00382
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE: (B)(6). PATIENT GENDER: FEMALE. THE EYE AFFECTED WAS THE RIGHT EYE. IT IS UNKNOWN IF THE BACKUP LENS WAS THE SAME MODEL AND DIOPTER 28.0. THE MANUFACTURING RECORD REVIEW INDICATED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO 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 CLAIM WAS GENERATED. A REVIEW OF PROCESS MANUFACTURING INSTRUCTIONS WAS DONE DURING THE PERIOD WHEN THIS PRODUCTION ORDER WAS MANUFACTURED AND DID NOT SHOW ANY CHANGE IN THE MANUFACTURING METHOD OR SPECIFICATIONS THAT COULD BE RELATED FOR THIS COMPLAINT TYPE. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PCB00V DEVICE RECEIVED IN THE ORIGINAL PRELOADED BOX WAS VISUALLY INSPECTED AT 18¿ DISTANCE WITH UNAIDED EYES. THE SYSTEM PROTECTIVE CAP WAS PLACED ONTO THE DEVICE AND NO ASSEMBLY ERROR WAS OBSERVED. CARTRIDGE WAS OBSERVED IN THE CORRECT POSITION (FULLY ENGAGED INTO LOWER BODY OF THE PCB00V DEVICE). NO DEFECTS IN THE PLUNGER/PUSH ROD TIP WAS IDENTIFIED THAT COULD AFFECT THE FUNCTIONALITY OF THE DEVICE. THE PLUNGER COMPONENT WAS OBSERVED IN A FULLY ADVANCED POSITION TO THE INDICATOR LINE. NO MOLDING DEFECT, BURR/SCAR INSIDE THE CARTRIDGE TUBE WAS IDENTIFIED THAT COULD RELATE AS A POSSIBLE CAUSES TO A FAILURE DURING SURGERY. IN ADDITION THE PCB00V DEVICE WAS INSPECTED UNDER MICROSCOPE AND THE HAPTIC WAS OBSERVED IN THE CARTRIDGE AT THE TUBE ZONE. VISCOELASTIC (OVD) RESIDUES WERE OBSERVED. THE PUSH ROD WAS OBSERVED TO OVERRIDE THE HAPTIC. THEREFORE, NO MANUFACTURING ASSEMBLY ERROR THAT COULD CAUSE THE CUSTOMER CLAIM WAS IDENTIFIED IN THE PRELOAD DEVICE. EVENT COULD BE RELATED TO INADEQUATE HANDLING OF THE DEVICE OR USE OF A NON-VALIDATED OPHTHALMIC VISCOELASTIC. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS DISPENSED FROM PRE-LOADED CARTRIDGE WITHOUT A TRAILING HAPTIC, HAPTIC HAD DETACHED AND REMAINED IN THE CARTRIDGE. THE IOL WAS REMOVED FROM THE EYE WHEREBY THERE WAS AN INCISION ENLARGEMENT FROM 2.4MM (MILLIMETERS) TO 3.0MM. A REPLACEMENT LENS WAS PLACED IN THE SAME PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450953 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention