BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR MULTIFOCAL TORIC

    MDR report key: 3830097 · Received May 1, 2014

    Report

    Report Number
    1119421-2014-00306
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ALCON RESEARCH, LTD. /HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, EMAIL, AND MAIL. COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT HAD A -3.0 MYOPIC RESULT AND EXPERIENCED PAIN IN THEIR EYE. THE SURGEON FEELS HIS BIOMETRY, CYLINDER AND POSITION WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261836 ACRYSOF IQ RESTOR MULTIFOCAL TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. /HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other