BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 934477 · Received October 25, 2007

    Report

    Report Number
    1119421-2007-00432
    Event Type
    Other
    Date Received
    October 25, 2007
    Date of Event
    June 1, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ALCON LABS, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER REPORTS IN THIS LOT OF PRODUCT. ADD'L INFO WAS REQUESTED ON 10/01/2007 BY MAIL AND BY FAX AND ON 10/02/2007, 10/09/2007 AND 10/10/2007 BY PHONE. ADD'L INFO INCLUDING THE QUESTIONNAIRE AND THE PATIENT'S RECORDS WERE RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED NOTICING SOME VISUAL DISTURBANCES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE VISUAL DISTURBANCES INCLUDE A SHADOW FROM THE CENTER OUT TO THE TEMPORAL SIDE OF HER VISION IN HER LEFT EYE ONLY AND A DARK RING WITH SYMBOLS ON IT THAT MOVES WITH THE EYE IN BOTH EYES. SHE ALSO REPORTED SEEING SOMETHING THAT LOOKS LIKE A MINI BUTTERFLY. SHE STATED THAT WHEN SHE LOOKS IN A MIRROR SHE SEES A SMALL BRIGHT LIGHT IN HER PUPILS IN BOTH EYES. SHE CAN ALSO SEE 5 RINGS AROUND ONE LIGHT. SHE REPORTS BEING NAUSEOUS AND HAS HAD A CHANGE IN HER APPETITE. ADD'L INFO RECEIVED FROM THE PHYSICIAN. HE STATED THE PATIENT HAS HAD SCOTOMA AND VITREOUS DETACHMENTS IN BOTH EYES (OU). HE ALSO RECOMMENDED THE PATIENT HAVE A NEURO-OPHTHALMOLOGY CONSULT. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS PATIENT: MEDWATCH 1119421-2007-00432 (OD - RIGHT EYE), MEDWATCH 1119421-2007-00433 (OS - LEFT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABS, INC./HUNTINGTON SN60D3 150860

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ZYMAR| PRED FORTE