BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2210566 · Received August 10, 2011

    Report

    Report Number
    1119421-2011-00968
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    May 6, 2010
    Report Date
    July 11, 2011
    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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED, THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 07/11/2011, 07/13/2011, 07/19/2011, AND 07/25/201 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/02/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S DAUGHTER REPORTED THAT HER MOTHER HAS CLOUDY VISION AND WAS RUBBING HER EYES A LOT BECAUSE, THEY ARE DRY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP PHONE CALL WITH THE CONSUMER, SHE REPORTED, HER VISION IS BLURRY AT BOTH DISTANCE AND NEAR. HER EYES WATER A LOT AND ARE UNCOMFORTABLE. SHE HAS BEEN SEEN BY THE SURGEON AND TOLD HER LENSES ARE FINE, BUT SHE HAS DRY EYES. SHE HAS BEEN GIVEN A PRESCRIPTION FOR GLASSES. IN A FOLLOW UP WITH THE SURGEON, IT WAS REPORTED, THAT THE CONSUMER'S SYMPTOMS ARE FELT TO BE DUE TO DRY EYE SYNDROME. THE PATIENT WAS INSTRUCTED TO USE TEARS FOUR TIMES A DAY. THE CONSUMER REPORTED TO THE SURGEON THAT SHE WAS ONLY USING THE TEARS AS NEEDED BECAUSE, HER EYES WERE ALREADY TEARING AND SHE DID NOT BELIEVE HER EYES WERE DRY DUE TO THIS. THE SURGEON REPORTED THAT POSTERIOR CAPSULE OPACIFICATION HAS BEEN OBSERVED AND A YAG LASER PROCEDURE HAS BEEN PERFORMED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10868228

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PROVISC| VISCOAT