BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2202138 · Received August 5, 2011

    Report

    Report Number
    9612169-2011-00042
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: A ROOT CAUSE COULD NOT BE DETERMINED BY THE INVESTIGATION. IT IS UNCLEAR HOW THE PRODUCT COULD HAVE CONTRIBUTED TO THIS EVENT. PRODUCT HISTORY RECORD REVIEWS FOR ALL ASSOCIATED COMPLAINTS DO NOT DEMONSTRATE ANY CORRELATION BETWEEN MFG SITES, MFG DATES AND THE IMPLANT DATES FOR THE PATIENTS. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED EIGHT CASES OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A F/U, THE USER FACILITY FURTHER CLARIFIED THAT EIGHT PATIENTS EXPERIENCED TASS ONE DAY AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY. CULTURES WERE TAKEN IN ONE CASE, WHICH WAS NEGATIVE. TWO OF THE EIGHT PATIENTS EXPERIENCED HYPOPYON AND THE OTHER SIX PATIENTS EXPERIENCED CELLS AND FLARE. ANTIBIOTICS WERE REQUIRED TO TREAT THE EVENT. THE EVENT RESOLVED WITH TREATMENT. IN THE SURGEON'S OPINION, IT WAS UNK IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS ALSO REPORTED THAT THERE WAS NO CHANGE IN THE PROCEDURES OF CLEANING AND STERILIZATION OF THE INSTRUMENTS. THERE ARE EIGHT MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE EIGHTH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21031105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MIOSTAT (USED FOR 4 OF 8 PATIENTS)| MONARCH HANDPIECE II| BALANCED SALT SOLUTION (BSS)| MONARCH CARTRIDGE B