BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2210958 · Received August 12, 2011

    Report

    Report Number
    9614546-2011-00066
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED CUT IN 2 PIECES PRECLUDING DIOPTER MEASUREMENT. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. VISUAL INSPECTION OF THE PRESENT OPTIC PARTS TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 18.5 DIOPTER OF THIS LOT NUMBER. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. OUR INVESTIGATION SHOWED NO PRODUCT DEFICIENCIES SUGGESTING THIS EVENT WAS NOT CAUSED BY THE IOL. 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.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND SENT TO THE MANUFACTURING SITE FOR ANALYSIS, RESULTS ARE PENDING. PRIOR TO RELEASE TO THE MARKET THE LENS MET ALL MANUFACTURING SPECIFICATIONS. AT THIS TIME AND BASED ON THE SURGEON'S REPORT OF INCORRECT DIOPTER USED WE DO NOT SUSPECT THE LENS WAS THE CAUSE OF THIS EVENT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXCHANGED 3 WEEKS AFTER IMPLANT FOR A CORRECTED POWER LENS. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. THE REASON STATED FOR THE EXPLANT WAS INCORRECT DIOPTER USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention