BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2662298 · Received July 19, 2012

    Report

    Report Number
    9614546-2012-00115
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 22, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS BEING CORRECTED TO THE VERIFIED EXPLANT DATE OF (B)(6), 2012.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER (ABBOTT MEDICAL OPTICS, (B)(4)) FACILITY: (B)(6) 2012. THE EXPLANTED LENS WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION AND REVEALED THAT THE LENS OPTIC WAS CUT IN HALF. NO OPTICAL DEVIATIONS WERE FOUND. FOLLOWING ABBOTT MEDICAL OPTICS PROTOCOL ON EXPLANTED LENSES, THE LENS WAS DECONTAMINATED PRIOR TO EVALUATION AND THUS THE REPORTED KIND OF MARK/DEPOSIT AS SEEN BY THE DOCTOR COULD NOT BE CONFIRMED IN OUR MANUFACTURING FACILITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EXPLANTED LENS, SHOWED THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. THE DIOPTER MEASUREMENT RECORDS VERIFIED AND WERE SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTIC POWER OF 25.0 DIOPTER FOR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: LENS RECEIVED BY ABBOTT MEDICAL OPTICS (B)(4). IN VISUAL EVALUATION OF THE LENS IT WAS FOUND TO BE CUT IN HALF WITH A DRY SUBSTANCE OBSERVED ON THE LENS. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE EYE. THE DRY SUBSTANCE APPEARS TO BE VISCOELASTIC; NO OTHER ANOMALIES WERE OBSERVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LENS WOULD BE EXPLANTED DUE TO PATIENT'S COMPLAINT OF A VISUAL DISTURBANCE AND THE PHYSICIAN'S OBSERVATION OF A ''KIND'' MARK ON THE LENS. THE REPORT WAS MADE TO ABBOTT MEDICAL OPTICS (AMO) ON (B)(6)-2012 WITH AN ANTICIPATED DATE OF SURGERY OF (B)(6)-2012. ON (B)(6)-2012 IT WAS CONFIRMED THAT THE LENS WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention