BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4142514 · Received October 6, 2014

    Report

    Report Number
    9614546-2014-00235
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS DELIVERED TO THE MANUFACTURER IN ONE PIECE. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWED THE LENS CAN BE IDENTIFIED AS TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRA OCULAR LENS BECAUSE OF THE TYPE OF HAPTICS AND THE PRESENCE OF A DIFFRACTIVE RING PATTERN ON THE OPTIC. THE LENS WAS CONTAMINATED, WHEREBY DUST PARTICLES WERE PRESENT. THIS IS EXPECTED AS THE LENS WAS TRANSPORTED FROM A CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON -STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT'S EYE. THE OPTIC SURFACE IS PARTIALLY COVERED WITH STAIN. THE INVESTIGATION OF THE RETURN SAMPLE DOES NOT SUGGEST OR SUPPORT THAT THE CONTAMINATION WAS INTRODUCED DURING MANUFACTURING. THE MANUFACTURING RECORD REVIEW INDICATED THAT THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS WITH RESPECT TO ORDER NUMBER. THERE WERE NO NONCONFORMANCES WITH RESPECT TO THE STERILIZATION PROCESS. THERE WERE NO ENVIRONMENTAL MONITORING RELATED NONCONFORMANCES WITHIN THE TIMEFRAME PRODUCTION ORDER. BASED ON THE MANUFACTURING RECORD REVIEW THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S VISUAL ACUITY WAS MUCH IMPROVED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN 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 AN INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE LEFT EYE OF A PATIENT WHEREBY THERE WAS AN INCISION ENLARGEMENT. IT WAS STATED THAT THE PATIENT WAS COMPLAINING ABOUT EXCESSIVE GLARE. THERE WAS NO VITRECTOMY PERFORMED AND THE IOL WAS REMOVED IN A SINGLE PIECE. THE IOL WAS REPLACED WITH A NEW STARR LENS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624693 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention