BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2972661 · Received February 21, 2013

    Report

    Report Number
    2648035-2013-00102
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS SENT TO AN OUTSIDE LABORATORY FOR ANALYSIS. A VISUAL EXAMINATION OF THE LENS DID NOT REVEAL ANY NOTICEABLE CLOUDINESS ON THE OPTIC BODY. THE SEVERITY OF THE LENS CLOUDING IN THE AS-RECEIVED CONDITION WAS RATED AS A "1" BASED ON THE LENS CLOUDINESS RATING SCALE. THE LENS WAS RECEIVED IN TWO PIECES. THE GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) CHROMATOGRAM FOR THE IPA EXTRACT OF THE OPTIC BODY WAS IDENTICAL TO THE IPA BLANK RUN FOR BACKGROUND/BASELINE. THE LENS WAS ANALYZED OF THE IPA (ISOPROPYL ALCOHOL) EXTRACT OF THE OPTIC BODY AND OF THE WATER SOLUTION. THE ANALYSIS DID NOT REVEAL ANY VOLATILE ORGANIC COMPOUNDS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN SENT TO AN OUTSIDE LABORATORY FOR EVALUATION.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    FOLLOW UP RECEIVED FROM THE SALES REPRESENTATIVE INDICATED THAT THE PATIENT WAS DOING WELL AFTER THE LENS REPLACEMENT. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ONE HALF OF THE INTRAOCULAR LENS (IOL)WAS RETURNED TO THE MANUFACTURER. THE SAMPLE WAS VISUALLY INSPECTED AT 10X MAGNIFICATION. NO GREASY OR CLOUDY LENS WAS IDENTIFIED. VISUAL INSPECTION WAS REQUESTED TO CONFIRM THAT THE RETURNED IOL WAS AN AMO Z9002. THE RETURNED IOL PORTION WAS COMPARED TO A Z9002 MODEL. THE RETURNED IOL WAS HARD AND THE EDGE IS NOT FROSTED AND IT IS SQUARE. THESE CHARACTERISTICS ARE COMPARABLE WITH AN ACRYLIC LENS DESIGN AND NOT WITH A SILICONE LENS OF Z9002. THE CHARACTERISTICS OF THE Z9002 INCLUDE A FROSTED EDGE. IN CONCLUSION, THE RETURNED IOL PORTION WAS DETERMINED NOT TO BE A Z9002 IOL. 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.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(4) RECEIVED A REPORT FROM A SURGEON WHO INDICATED HIS PATIENT HAD AN INTRAOCULAR LENS (REPORTEDLY A TECNIS CL Z9002) IMPLANTED AT A DIFFERENT SITE TWO YEARS EARLIER. THE SURGEON FOUND THE VISUAL ACUITY OF THE PATIENT WAS DETERIORATING AND IDENTIFIED THE CAUSE AS THE 2-YEAR-OLD IOL WHICH HE DESCRIBED AS GREASY / CLOUDY. AN AMO SALES REP WAS PRESENT AT THE SURGERY IN WHICH THE LENS WAS EXPLANTED. ANOTHER LENS(DETAILS NOT PROVIDED) WAS IMPLANTED DURING THE SAME PROCEDURE. THE SALES REP REPORTED THAT HE DID NOT FIND ANY CLOUDINESS ON THE IOL VISUALLY ON THE MONITOR IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75681 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention