BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943542 · Received December 3, 2010

    Report

    Report Number
    1119421-2010-01336
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; 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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A UCVA OF 20/100 AND PT DESCRIBING SEEING A MARK ON THE INTRAOCULAR LENS (IOL) FOLLOWING IOL IMPLANT SURGERY. THE SURGEON REPORTED BEING UNABLE TO SEE A SCRATCH ON THE IOL AFTER MULTIPLE EXAMINATIONS. THE PT SENT A LETTER DESCRIBING A FIGURE WHICH APPEARED AS A "LESSER THAN SIGN (<)" WHICH WAS DARK BROWN IN COLOR INITIALLY. THE CONSUMER NOTED THE FIGURE ON THE FIRST POSTOPERATIVE DAY WHEN HIS PATCH WAS REMOVED. THE FIGURE BECAME LIGHTER THROUGH THE WEEK UNTIL IT BECAME TRANSLUCENT AND ALLOWED THE LIGHT TO COME THROUGH, BUT NOT IMAGES. AFTER ANOTHER WEEK, THE CONSUMER REPORTED IT ALLOWED IMAGES, BUT THE IMAGES WERE BLURRY. THE CONSUMER REPORTED HE WAS ONLY ABLE TO SEE LETTERS WHEN HE LOOKED TOWARDS THE RIGHT OF THE IOL, WHERE THE FIGURE WAS NOT PRESENT. THE CONSUMER REPORTED THE FIGURE IS ALWAYS PRESENT AND HIS VISION IS THE SAME AS WHAT HE EXPERIENCED WITH HIS CATARACT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10978974

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other