BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 3032499 · Received April 1, 2013

    Report

    Report Number
    1119421-2013-00336
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLURRED VISION DUE TO HAVING "AN INCORRECT REFRACTION LENS IMPLANTED", FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO RECEIVED FOR THE CONSUMER INDICATED THAT HIS SURGEON DIAGNOSED HIM WITH A ROTATED LENS. THE SURGEON PERFORMED A CORRECTIVE SURGICAL PROCEDURE IN WHICH THE IOL WAS ROTATED 30 DEGREES. THE CONSUMER DID NOT PROVIDE CONTACT INFO FOR THE IMPLANTING SURGEON; THEREFORE, ADDITIONAL INFO COULD NOT BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132008 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention