BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 3830086 · Received May 1, 2014

    Report

    Report Number
    1119421-2014-00307
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    January 1, 2012
    Report Date
    April 6, 2014
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE. THE SURGEON'S CONTACT INFORMATION WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS THAT SHE HAS HAD SEVERAL PROCEDURES TO HELP WITH VISION RELATED PROBLEMS WITH NO SUCCESS. SHE WILL REQUIRE THE USE OF GLASSES AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE SURGEON'S INFORMATION HAS NOT BEEN PROVIDED. THERE ARE TWO MEDICAL DEVICE REPORTS RELATED TO THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261531 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention