BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4103295 · Received September 19, 2014

    Report

    Report Number
    2648035-2014-00491
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    November 12, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT- UNKNOWN. NOT APPLICABLE THE LENS REMAIN IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LENS SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE HALF OF THE LENS WAS RECEIVED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED THAT THE HALF RECEIVED HAD SURFACE RESIDUALS (FIBER/PARTICLES) AND WHAT APPEARED TO BE VISCOELASTIC RESIDUES. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. NO FURTHER TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE DATE OF EVENT: (B)(6) 2014. IF EXPLANTED, GIVE DATE: (B)(6) 2014. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT WAS LEARNED THAT PATIENT IS SCHEDULED FOR AN UPCOMING EXPLANT OF IOL ON (B)(6)-2014. DEVICE EVALUATION: A REVIEW OF THE MANUFACTURING RECORD WAS CONDUCTED. THE DOCUMENTATION SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING SPECIFICATIONS. A REVIEW OF THE PRODUCTION ORDER SHOWED PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) Z9002 HAS CLOUDED INSIDE THE OPTIC AND IS AFFECTING THE PATIENT¿S VISION IN THEIR LEFT EYE. THE PATIENT HAS BEEN HAVING DIFFICULTY READING ANYTHING CLOSE, EVERYTHING APPEARS BLURRED CLOSE UP, AND IS AFFECTING HER DAILY ACTIVITIES. THE PATIENT HAS BEEN REFERRED TO A RETINA SPECIALIST. THE DOCTOR IS PLANNING TO EXPLANT THE LENS IN THE FUTURE. AS OF NOW THE LENS REMAIN IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATING THE INTRAOCULAR LENS (IOL) HAS BEEN EXPLANTED IN A SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584948 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R