BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3232569 · Received July 18, 2013

    Report

    Report Number
    2648035-2013-00294
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION NOTED THAT THE LENS WAS RECEIVED CUT IN TWO (2) PARTS (NO HAPTICS OBSERVED). A FEW LOOSE PARTICLES WERE OBSERVED IN THE OPTIC ZONE COMPATIBLE WITH HANDLING THE LENS SUCH AS IN THE EXPLANT PROCESS. THE CONDITION OBSERVED IN THE LENS WAS CONSISTENT WITH A LENS THAT HAD BEEN IMPLANTED AND EXPLANTED. LENS WAS RECEIVED CUT IN HALF INDICATING THAT IT HAD BEEN EXPLANTED. DIOPTER MEASUREMENT WAS NOT PERFORMED AS THE CONDITION OF THE LENS WAS NOT ADEQUATE FOR DIOPTER MEASUREMENT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. NO PRODUCT DEFICIENCY WAS IDENTIFIED IN THE INVESTIGATION. CATALOG #: ZMB00U0260. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE MYOPICS SURPRISE HAS BEEN MINIMIZED. THE PATIENT IS HEALTHY, BUT EXPERIENCED DRY EYES. (B)(4). CORRECTED DATA: EXPIRATION DATE: 11/01/2016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHERE AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AFTER THEY EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. NO SUTURES WERE REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333644 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention