BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2340089 · Received November 11, 2011

    Report

    Report Number
    9612169-2011-00059
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. ADD'L INFO WAS REQUESTED 10/14/2011, 10/17/2011 AND 10/20/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADD'L INFO WAS RECEIVED IN A FOLLOW-UP PHONE CALL ON 10/14/2011. (B)(4).

    Description of Event or Problem · 1

    AN INFECTION PREVENTIONIST REPORTED A PT WHO WAS DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP PHONE CALL, THE TECHNICIAN REPORTED THE PT WAS SENT TO A RETINAL SPECIALIST WHO TREATED THE PT WITH A MEDICATION AND THE SURGEON INCREASED THE PT'S ROUTINE POSTOPERATIVE MEDICATIONS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21034577

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention NEO-SYNEPHRINE 2.5%| MONARCH HANDPIECE III| TETRACAINE .5%| UNK MONARCH CARTRIDGE| BSS| NEVANAC .1%| VIGAMOX .5% DIOVISC| INFINITY PHACOEMULSIFICATION UNIT| BROMDAY| MYDRIACYLE 1%| PREDNISOLONE ACETATE 1%