BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1230247 · Received November 7, 2008

    Report

    Report Number
    1119421-2008-00886
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    February 25, 2008
    Report Date
    October 10, 2008
    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
    KY, US
    Reporter Occupation
    UNKNOWN

    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. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 10/10/2008, 10/21/2008, 10/23/2008, 10/28/2008, AND 10/31/2008 AND VIA FAX AND MAIL ON 10/13/2008. A COMPLETED QUESTIONNAIRE AND MEDICAL RECORDS WERE RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 11/07/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE IS SUFFERING FROM MULTIPLE PROBLEMS INCLUDING LIGHT FLASHING, BLURRING, WHITE HALOS AND RIBBONS AROUND TELEVISION AND LIGHTS AT NIGHT, DOUBLE VISION, POOR VISION, SWOLLEN EYE LIDS, AND EXTREME DRYNESS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED HER VISION WAS GOOD AND HER EYES WERE HEALTHY BEFORE HER IMPLANT SURGERY. THE PATIENT'S SURGEON REPORTED THE PATIENT HAD GOOD UNCORRECTED VISION EARLY ON, BUT HAS COMPLAINED OF BLUR, GLARE, AND HALOS THAT WORSENED FOR A WHILE THEN STABILIZED, BUT HAVE NOT IMPROVED. HE STATED THE PATIENT'S EYES LOOK VERY NORMAL FOR HER AGE. HE REPORTED THE PATIENT HAS SEEN SEVERAL DIFFERENT PRACTITIONERS AND HAS INSISTED TO THEM THAT HER LIDS ARE SWOLLEN, BUT NO ONE NOTICED ANY SWELLING. ONE OF THE PHYSICIANS THAT SAW THE PATIENT IN A FOLLOW UP VISIT DID NOT RECOMMEND FURTHER TREATMENT EXCEPT FOR HER DRY EYE. ANOTHER PHYSICIAN REPORTED HE FOUND THE PATIENT'S IOL WAS BEAUTIFULLY CENTERED AND HER RETINAS WERE INTACT. THE SURGEON REPORTED HE BELIEVES THE PATIENT'S PROBLEM IS DUE TO HER DEPRESSION AND HE HAS BEEN UNABLE TO GET HER TO SEEK TREATMENT FOR IT. HE NOTED THE OUTCOME OF THE EVENT FOR THE PATIENT AS "POOR" BUT THAT THE IOL DID NOT CONTRIBUTE TO THE PATIENT'S EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10738432

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other PENICILLIN| CDN| VERSED| RESTASIS| THERA TEARS| TYLOX