BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4141241 · Received October 3, 2014

    Report

    Report Number
    2648035-2014-00524
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 2, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW INDICATED THAT THERE WERE NO NON-CONFORMANCES WITH RESPECT TO THE FINAL PRODUCT RELEASE PROCESS. THE IN-LINE OPTICAL INSPECTION DATA SHOWED THAT THE LENS WAS WITHIN POWER SPECIFICATION. THERE WERE NO PROCESS AND / OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER NUMBER. THERE WERE NO NON-CONFORMANCES WITH RESPECT TO THE STERILIZATION PROCESS. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LENS WAS RECEIVED CUT IN PIECES, MOST PROBABLY TO MAKE THE EXPLANT POSSIBLE. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWED THE LENS CAN BE IDENTIFIED AS TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRAOCULAR 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 CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE PATIENT¿S EYE. CONSIDERING THE CONDITION OF THE LENS, DIOPTER MEASUREMENT COULD NOT BE PERFORMED. ADDITIONAL ANALYSIS IS NOT POSSIBLE. VISUAL INSPECTION OF THE RETURN SAMPLE SHOWS THE LENS IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FOLLOW-UP WITH THE REPORTER INDICATED THAT THE EXPLANT DATE IS BEING CORRECTED TO (B)(6) 2014. DATE OF EVENT: (B)(6) 2014. EXPLANT DATE: (B)(6) 2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE, IN A SECONDARY PROCEDURE, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION WITH MYOPIC OUTCOME. NO INCISION ENLARGEMENT OCCURRED AND VITRECTOMY WAS NOT PERFORMED. A REPLACEMENT LENS WAS PLACED. THE REPLACEMENT LENS WAS OF A MONOFOCAL LENS, LENS MODEL AND SERIAL NUMBER WAS NOT PROVIDED. PATIENT WAS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620780 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention