BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3830118 · Received May 1, 2014

    Report

    Report Number
    1119421-2014-00300
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    February 24, 2014
    Report Date
    April 1, 2014
    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
    IN, US
    Reporter Occupation
    UNKNOWN

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

    Description of Event or Problem · 1

    AN INDIVIDUAL REPORTED THAT A CONSUMER HAD AN UNEXPECTED POST-OP REFRACTION AFTER HAVING AN INTRAOCULAR LENS (IOL) IMPLANTED. IN A FOLLOW UP, AN INDIVIDUAL AT THE FACILITY REPORTED THAT THE IOL WILL NOT BE EXCHANGED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262087 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. /HUNTINGTON MN6AD1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other