BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2061047 · Received April 13, 2011

    Report

    Report Number
    1119421-2011-00411
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 14, 2011
    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
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET ALL RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE MAY BE RELATED TO PT CONDITION/NON PRODUCT FACTORS. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON (B)(4) 2011 AND (B)(4) 2011 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON (B)(6) 2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/13/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S DAUGHTER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER FATHER HAS NOT BEEN ABLE TO SEE WELL FOR DISTANCE (CORRECTABLE WITH GLASSES) AND IS EXPERIENCING PAIN, DIZZINESS, AND HALOS. SHE REPORTED THAT HER FATHER TAKES MEDICATION FOR HIS PROSTATE. SHE ALSO REPORTED THAT ACCORDING TO THE SURGEON, THE "FLOPPY IRIS MADE THE MEASUREMENTS WRONG." MEDICAL RECORDS WERE RECEIVED FROM THE CONSUMER'S DAUGHTER. THE RECORDS INDICATED THE FOLLOWING: DURING SURGERY, THE PT WAS PUT UNDER GENERAL ANESTHESIA AS THE PT COULD NOT STAY AWAKE AND KEPT MOVING. AT POSTOPERATIVE VISITS, NINE DAYS AFTER THE SURGERY, THE PT REPORTED BLURRY VISION, AND AT 18 DAYS AFTER SURGERY, THE PT REPORTED HE WAS CONCERNED WITH MYOPIA IN THE OPERATED EYE (NOTATION BY A HEALTH CARE PROFESSIONAL INDICATED THAT EYE MAY BE HEALING MORE NEARSIGHTED THAN COMPUTER SCAN PREDICTED). AT TWENTY DAYS POSTOPERATIVE, THE PT CALLED INTO THE CLINIC AND REPORTED EXPERIENCING DIPLOPIA, GHOST IMAGES, AND BLUR. AT APPROXIMATELY ONE MONTH POSTOPERATIVELY, THE PT REPORTED BEING "VERY UNHAPPY" WITH VISUAL ACUITY AND WANTED IOL TO BE EXCHANGED. THE SURGEON ADVISED THE PT HE DOES NOT RECOMMEND A SECOND SURGERY DUE TO THE RISK OF COMPLICATIONS AND SINCE THE PT HAS RESUMED TREATMENT FOR HIS PROSTATE, THIS MAY MAKE SURGERY DIFFICULT. IN A PHONE F/U, SIX WEEKS POSTOPERATIVELY, THE DAUGHTER OF THE CONSUMER REPORTED THAT UPON CONSULTATION WITH THE SURGEON, HE STATED THAT "THE CALCULATIONS WERE OFF SO THE LENS IN THE EYE WAS NOT THE CORRECT ONE BUT HE WOULD GIVE [HER FATHER] PRESCRIPTION FOR GLASSES." SHE ALSO REPORTED THE SURGEON GAVE HER FATHER MEDICATION FOR DRY EYES AS IT MAY CONTRIBUTING TO THE HALOS. ADDITIONAL 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 10948261

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other #25-GAUGE NEEDLE CYSTOTOME| PILOPINE| I/A HANDPIECE| PROVISC OR HEALON| ASPIRIN| CHONDROITIN| HYTRRIN| UROXATROL| LOVASTATIN| METOPROLOL| MAXITROL| 10-0 NYLON SUTURE| CYCLODIALYSIS SPATULA| VERSED| LIDOCAINE| SUPERBLADE| CRESCENT BLADE| #25 GAUGE NEEDLE CANNULA| BSS| GLUCOSAMINE