BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESOTR

    MDR report key: 3093668 · Received May 1, 2013

    Report

    Report Number
    1119421-2013-00465
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ALCON RESEARCH. LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDED A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION A COMPLETE QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING HALOS, STARBURSTS, GHOST SHADOWS AND FEELING HER VISION WAS OUT OF FOCUS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT HAD WRITTEN THE SURGEON A LETTER EXPLAINING THAT OBJECTS AT DISTANCE AND UP CLOSE LOOKED SOMEWHAT FUZZY AND WORDS WERE HARD TO READ (OUT OF FOCUS). WHEN SHE WAS AT WORK, HER EYES CONTINUED TO BE OUT OF FOCUS FOR COMPUTER WORK AND SHE WAS HAVING TO WEAR READING GLASSES TO READ THE COMPUTER SCREEN. THE CONSUMER REPORTED THE HALOS AND STARBURSTS WERE OCCURRING AROUND LIGHTS DURING THE DAY AND AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189424 ACRYSOF RESOTR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other