BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3843961 · Received June 2, 2014

    Report

    Report Number
    2648035-2014-00285
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE RAW MATERIAL/MANUFACTURING PROCEDURES IN 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 PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR, THE DATE OF EVENT WAS RECORDED AS THE DATE THE LENS WAS EXPLANTED. THE CORRECT DATE IS THE DATE THE LENS WAS DISPLACED. DATE OF EVENT: (B)(6) 2014. CONCOMITANT MEDICAL PRODUCTS: ALCON CARTRIDGE, LOT NUMBER UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY STATING THAT THE LENS WAS PARTIALLY DISPLACED POST OP DAY ONE AND THAT THE DOCTOR DID A LENS ROTATION. AFTER THE REPOSITION THE DOCTOR NOTED A SCRATCH ON THE LENS AND DID A LENS EXCHANGE. IT IS UNKNOWN WHEN THE LENS WAS SCRATCHED. THE SURGEON CLAIMS THAT HE DID NOT SCRATCH THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LENS HAD VISCOELASTIC RESIDUE AND HAD ONE SCRATCH. A RED STAIN THAT APPEARED TO BE BLOOD WAS OBSERVED ON THE LENS HAPTICS (BOTH). VISUAL INSPECTION REVEALED THAT DEBRIS/PARTICLES WERE OBSERVED ON THE LENS, WHICH WAS COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN REMOVED FROM THE PATIENT'S EYE. NO DEFECTS RELATED TO MANUFACTURING PROCESS WERE FOUND IN THE SAMPLE RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. PER THE SURGEON, IT WAS STATED THAT THERE WAS A SCRATCH ON THE LENS. IT WAS STATED THAT THE LENS WAS REPLACED WITH ANOTHER 13.5 DIOPTER ZMB00 LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321451 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ALCON CARTRIDGE, LOT NUMBER UNKNOWN