BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1253141 · Received December 5, 2008

    Report

    Report Number
    1119421-2008-00994
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    May 1, 2008
    Report Date
    November 6, 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
    TX, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 11/07/2008, 11/12/2008, 11/13/2008, AND 11/21/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT THAT EXPERIENCED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR (IOL) IMPLANT SURGERY. THE PATIENT REPORTED HAVING DIFFICULTY READING AND BLURRY DISTANT VISION. HE STATED THAT HIS PERIPHERAL VISION HAD A TRIANGLE SHAPE THAT WAS BLACK AND WORSE IN THE MORNING. THE SURGEON REPORTED THE PATIENT WAS TAKING MEDICATIONS FOR BENIGN PROSTATIC HYPERTROPHY THAT HAD PRODUCED A "FLOPPY IRIS". IN 2008, THE PATIENT WAS DIAGNOSED WITH A PARTIAL RETINAL DETACHMENT AND SENT TO A RETINAL SPECIALIST WHO PERFORMED A CRYOPNEUMATIC RETINOPEXY. CYSTOID MACULAR EDEMA (CME) WAS ALSO NOTED IN THE SAME MONTH. LASIK WAS PERFORMED IN APPROX FOUR MONTHS LATER. AS OF THE FOLLOWING MONTH, THE PATIENT STATED THAT "VISION WORSE THAN PREVIOUS" AND THAT HE "CAN'T READ AT ALL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. /HUNTINGTON SN6AD3 10723204

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention URAXATROL| VISCOAT AND BSS