BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2030007 · Received March 25, 2011

    Report

    Report Number
    2648035-2011-00051
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS RECEIVED CUT IN PIECES ACROSS THE OPTIC PRECLUDING MEASUREMENT OF THE DIOPTER . THE DIOPTER RESULT FOR THE SERIAL NUMBER AFFECTED WAS REVIEWED IN THE BATCH RECORDS AND THE RESULT SHOWS THAT THE LENS WAS MANUFACTURED AS AN 18.0 DIOPTER AS LABELED. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND MET ALL MANUFACTURING SPECIFICATIONS. OUR INVESTIGATION REVEALED NO PRODUCT DEFICIENCY SUGGESTING THE LENS WAS NOT THE CAUSE OF THIS EVENT. THE MULTIFOCAL LENS WAS EXCHANGED FOR A MONOFOCAL LENS, NO PATIENT INJURY. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRAOCULAR LENS (IOL) WAS NOT RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. ALL INFORMATION AVAILABLE IS CONTAINED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF THIS EVENT FIELD CORRECTED TO (B)(6) 2011

    Additional Manufacturer Narrative · 1

    CORRECTED DATE OF EVENT TO (B)(6) 2011 . ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED WITHOUT COMPLICATION 1 MONTH AFTER INITIAL IMPLANT. REASON STATED WAS THE PATIENT'S BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention