BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2246640 · Received September 7, 2011

    Report

    Report Number
    9612169-2011-00050
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION: 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 DATES. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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 ON 08/19/2011 AND 08/25/2011 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED ON 08/22/2011 AND 08/25/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED TWELVE PTS WHO PRESENTED WITH INFLAMMATION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE NURSE REPORTED THAT ALL PTS WERE TREATED WITH MEDICATION AND THE INFLAMMATION RESOLVED. SHE STATED THE SURGERY CENTER HAS CHECKED FOR POSSIBLE FACTORS LEADING TO THE INFLAMMATION. IN A F/U, THE TECH INDICATED THAT THE INFLAMMATION PRESENTED ONE DAY POSTOPERATIVELY, WAS ALMOST FIBROUS IN APPEARANCE AND WHITE CELLS WERE PRESENT. ALSO, THE ADMINISTRATOR FOR THE FACILITY REPORTED THAT THE FACILITY IS A MULTI-SURGERY CLINIC BUT DOES NOT MIX CLEANING OF THE OPHTHALMIC INSTRUMENTS WITH OTHER OPERATIVE INSTRUMENTS. HE REPORTED THAT THE MEDICATION REGIMENT OF THE SURGEON WAS REVIEWED. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SIXTH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21034185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TIMOLOL| BRIMONIDINE| BALANCED SALT SOLUTION PLUS| OMNIPRED