BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2120292 · Received June 7, 2011

    Report

    Report Number
    1119421-2011-00709
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 8, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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: NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SERIES OF POSTOPERATIVE INFECTIONS IN PTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE CASES WERE ALL PERFORMED ON THE SAME DAY. THERE WAS ONE ENDOPHTHALMITIS AND THREE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) CASES INVOLVING THE LEFT EYE (TWO CASES) AND RIGHT EYE (ONE CASE). PT IDENTIFIERS REMAIN UNK. THE NURSE ALSO INDICATED THAT A NUMBER OF OTHER MEDICAL DEVICES WERE USED DURING THE PROCEDURES. IN A F/U, THE NURSE REPORTED THE FACILITY "DOES NOT BELIEVE THIS MFR'S PRODUCTS TO BE THE PROBLEM BUT THEY WANTED TO COVER ALL BASES." ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT PRESENTS THE TASS CASES THAT INVOLVED THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KELMAN TIPS| HEALON| INFINITI VISION SYSTEM| PAK| OZIL HANDPIECE| INTREPID TUBING