BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1914374 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01284
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2009
    Report Date
    October 24, 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
    CT, 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 INFO WAS REQUESTED ON 10/29/2010 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/05/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER VISION "KEPT CHANGING" AND THAT SHE WAS GIVEN A STRONGER PRESCRIPTION FOR GLASSES FOR DISTANCE AND READING. SHE REPORTED THAT HER VISION IS NOT AS GOOD AS SHE WAS TOLD IT WOULD BE. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT AND THAT THE PT'S ASTIGMATISM WAS CORRECTED BY THE IOL (PERFORMED AS EXPECTED). THE SURGEON STATED THAT THE PT HAD RESIDUAL MYOPIA WHICH INCREASED BY -0.25 D OVER A SIX MONTH PERIOD WHICH THE SURGEON FELT WAS DUE TO THE PT'S PREOPERATIVE USE OF CONTACT LENS. EVENT HAS RESOLVED WITH NEW GLASSES. POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10911007

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other HEALON GV ON