BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3031786 · Received April 2, 2013

    Report

    Report Number
    2648035-2013-00148
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN THEIR RIGHT EYE, WHICH LED TO A UNEXPECTED POST-OPERATIVE REFRACTIVE SURPRISE OF -2.0 AS SEEN ON THE PATIENT'S ONE WEEK POST OPERATIVE VISIT. IT WAS REPORTED THAT THE PATIENT HAD A POSTERIOR CAPSULOTOMY ON (B)(6) 2013 WHICH WAS EXPECTED TO HELP WITH THE MILD OPACIFICATION. THE DOCTOR REPORTS THAT THE CAPSULAR BAG HAS TIGHTENED UP OR THERE IS FLUID BUILD UP WHICH COULD HAVE CAUSED THE REFRACTIVE ERROR JUMP SO QUICKLY FROM -.25 TO -2.00. THE PATIENT HAS A 20MM EYE LENGTH. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133681 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other