BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4760275 · Received May 8, 2015

    Report

    Report Number
    9614546-2015-00106
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED LENS WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION SHOWED THE LENS IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. THE REPORTED COMPLAINT OF UNEXPECTED POSTOP REFRACTION COULD NOT BE CONFIRMED. DUE TO THE CONDITION OF THE RETURNED LENS, NO FURTHER INVESTIGATION COULD BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED. THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE FINAL PRODUCT RELEASE. THE PRODUCTION ORDER WAS NOT PRODUCED UNDER DEVIATION. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER. THE COMPLAINT RELATED ASSOCIATED TEST IS THE OPTICAL MEASUREMENT PERFORMED AT FINAL INSPECTION. THE IN-LINE OPTICAL INSPECTION DATA SHOWED THE LENS WAS WITHIN POWER SPECIFICATION. THE LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    TO INITIAL REPORT, LABELED FOR SINGLE USE? YES SHOULD BE CHECKED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED, FROM THE PATIENT'S LEFT EYE, IN A SECONDARY PROCEDURE DUE TO POST OPERATIVE REFRACTIVE OUTCOME. PATIENT CAME OUT NEARSIGHTED AND DID NOT HAVE GOOD DISTANCE. THE INCISION WAS NOT ENLARGED AND NO OTHER SURGICAL INTERVENTION WAS INDICATED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A SMALLER DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302491 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZKB00

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention