BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4200183 · Received October 24, 2014

    Report

    Report Number
    2648035-2014-00569
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 10/22/2014. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THE REVIEW OF THE DOCUMENTATION AND TESTING PRESENTED IN THE MANUFACTURING RECORD WERE FOUND WITHIN PRODUCT SPECIFICATIONS. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER'S REPORT WAS GENERATED. NO DEBRIS OR PARTICLES ISSUES WERE REPORTED DURING THE MANUFACTURE OF THE LENS. THE DOCUMENTATION SHOWED 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

    THE INTRAOCULAR LENS WAS NOT EVALUATED. HOWEVER, THE DEBRIS REPORTED WAS EVALUATED BY AN OUTSIDE LABORATORY TO IDENTIFY THE DEBRIS. AN INTRAOCULAR LENS WAS SUBMITTED FOR ANALYSIS BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY IN ORDER TO CHARACTERIZE DEBRIS/PARTICLES REPORTEDLY OBSERVED ON THE LENS. A VISUAL EXAMINATION REVEALED A TRANSLUCENT FIBER ON THE UNDERSIDE OF THE LENS AS IT WAS RECEIVED IN THE CARTRIDGE AND THIS WAS THE MATERIAL THAT WAS ANALYZED. FTIR ANALYSIS OF THE FIBER SHOWS THAT IT IS CELLULOSE (I.E. RAYON, LINT, COTTON). THESE MATERIALS ARE NOT USED IN THE MANUFACTURE OF THE INTRAOCULAR LENSES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEE SUBMITTED.

    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 THE INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY PROCEDURE, FROM THE PATIENT'S RIGHT EYE, DUE TO DEBRIS. THERE WAS NO PATIENT INJURY REPORTED AND ANOTHER LENS, SAME MODEL WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680181 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention CARTRIDGE, MODEL PSCST, LOT # UNKNOWN