BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLRFLXC

    MDR report key: 1990046 · Received February 15, 2011

    Report

    Report Number
    2648035-2011-00014
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THAT THE INSPECTIONS FOR THE AFFECTED PRODUCTION ORDER MET ALL SPECIFICATIONS. WITH THIS RECORD REVIEW AND THE CUSTOMER FEEDBACK, WE COULD NOT IDENTIFY ANY PROCESS DEVIATION. HALF OF THE INTRAOCULAR LENS OPTIC WAS RECEIVED FROM THE LABORATORY THE INTRAOCULAR LENS WAS RETURNED TO BY THE SURGEON. THE PARTIAL LENS RECEIVED WAS SUBMITTED BY THE MANUFACTURER TO AN INDEPENDENT LABORATORY FOR GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) ANALYSIS. PRIOR TO GC/MS THE LENS WAS INSPECTED AND NO CLOUDINESS WAS OBSERVED IN THE OPTIC. THE LENS WAS HYDRATED OVERNIGHT AND REINSPECTED, A CLOUDINESS WAS NOT OBSERVED. FOLLOWING HYDRATION AND VISUAL INSPECTION THE LENS WAS EXTRACTED OVERNIGHT IN ISOPROPYL ALCOHOL (IPA). THE IPA EXTRACT AND BALANCED SALT SOLUTION IN WHICH THE IOL WAS RECEIVED FROM THE LAB WERE ANALYZED USING GC/MS. THE TWO MAIN COMPOUNDS FOUND IN THE IPA EXTRACT OF THE OPTIC BODY WERE LIDOCAINE AND BUTYLATED HYDROXYTOLUENE. MASS IONS ASSOCIATED WITH HYDROCARBONS (BRANCHED ALKANES) AND ALCOHOLS WERE ALSO SEEN, AS WELL AS SOME AROMATICS. GC/MS ANALYSIS OF THE BALANCED SALT SOLUTION DID NOT YIELD ANY REMARKABLE RESULTS. THE 2 MAIN COMPOUNDS FOUND IN THE IPA EXTRACT ARE NOT COMPOUNDS USED IN THE MANUFACTURE OR PACKAGING OF THE DEVICE. BASED ON THE RESULTS OF OUR INVESTIGATION WE WERE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THE SURGEON'S OBSERVATION. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT BY THE SURGEON TO AN INDEPENDENT LABORATORY FOR ANALYSIS AND NOT RETURNED TO THE MANUFACTURER. PRIOR TO RELEASE THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THE REMAINING LENSES MANUFACTURED IN THIS LOT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PRODUCTION RECORDS ARE BEING REVIEWED AT THE MANUFACTURING SITE. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    AT ONE DAY POSTOPERATIVELY THE PATIENT'S VISUAL ACUITY WAS 20/60 AND THE LENS OPTIC WAS CLOUDY. LENS WAS REPLACED AND PATIENT RECOVERED WITHOUT SEQUELAE. LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A CASE OF EARLY OPACIFICATION OF THE IMPLANTED INTRAOCULAR LENS. THE LENS WAS EXPLANTED WITHOUT COMPLICATION ON A DATE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLRFLXC MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS CLRFLXC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention