BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1941849 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01403
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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 11/23/2010 AND 12/01/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE REC'D (B)(4) 2010, A COMPLETED QUESTIONNAIRE WAS REC'D (B)(4) 2010, AND ADDITIONAL INFORMATION WAS REC'D BY PHONE (B)(4) 2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REC'D AND REVIEWED. THE DAY FOLLOWING IMPLANT SURGERY, THE EYE HAD 2+ EDEMA, CORNEAL ABRASION, AND INTRAOCULAR PRESSURE (IOP) WAS ELEVATED AT 49 MMHG. A PARACENTESIS WAS PERFORMED AND IOP DROPPED TO 18 MMHG. THE PT WAS STARTED ON MEDICATION TO TREAT ELEVATED IOP. ONE WEEK FOLLOWING THE IMPLANT, THE PT REPORTED BLURRY VISION, SEEING FLASHES OF LIGHT ON THE LEFT HAND SIDE AND A "WHITE COTTON BALL BLOB" EVERY 15 MINUTES THAT GOES AWAY WITH BLINKING. THREE WEEKS POSTOPERATIVELY, THE PT'S VISION WAS STILL "FUZZY" AND HE REPORTED A FLOATER. SIX WEEKS POSTOPERATIVELY, THE PT CONTINUED TO REPORT THAT HE COULD NOT SEE WELL. IN A F/U WITH THE SURGEON, HE REPORTED THAT HE DOES NOT HAVE A PROBABLE CAUSE FOR THE EVENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 11027832

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other VISCOAT| MONARCH DELIVERY SYSTEM| BSS| PROVISC