BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1821682 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00955
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 08/05/2010 BY FAX AND MAIL. MEDICAL RECORDS AND A COMPLETED QUESTIONNAIRE WERE RECEIVED ON 08/12/2010. A COMPANY OPHTHALMOLOGIST REVIEWED THE CALCULATIONS PROVIDED BY THE FACILITY. SERIAL K'S SHOW AND OUTLYING READING ON THE MANUAL K READING. AVERAGE MANUAL VERSUS AUTO-K VERSUS IOLM K'S WERE REVIEWED WHICH SHOWED THAT THE DIFFERENCE BETWEEN THE AVERAGE MANUAL K AND IOLM K WAS 0.68D. THE REFRACTIVE SURPRISE HAS A SE = -0.75D. WHEN THE IOLM K'S ARE USED IN THE CALCULATIONS, THIS RESULTS IN AN IOL POWER 0.50D TO 1.00D (+18.0D OR +18.5D) DIFFERENCE AND ACCOUNTS FOR THE REFRACTIVE SURPRISE (+19.0D WAS IMPLANTED). THESE FINDINGS WERE DISCUSSED WITH THE SURGEON WHO INDICATED THAT SHE DOES NOT THINK IOL IS DEFECTIVE AND THAT THE POTENTIAL CAUSE FOR THE REFRACTIVE SURPRISE IS INACCURATE K READINGS (BIOMETRY). (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED, A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED, THE PT IS "NOT UNHAPPY" WITH THE OUTCOME. IN A F/U, THE SURGEON REPORTED THAT THE EVENT CONTINUES AND THERE WERE NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. IN HER OPINION, THE DEVICE DID NOT CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10901968

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other MONARCH DELIVERY SYSTEM| VISCOELASTIC