BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2063819 · Received April 15, 2011

    Report

    Report Number
    1119421-2011-00425
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 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 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 LOT NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. ADD'L INFO HAS BEEN REQUESTED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT, THE PT'S VISION WAS 20/25 ONE DAY POSTOPERATIVELY, THEN IT DECREASED SIGNIFICANTLY "OVER THE WEEKEND" (TWO TO THREE DAYS POSTOPERATIVELY) DUE TO CORNEAL DECOMPENSATION/EDEMA. THE SURGEON REPORTED THAT, ALTHOUGH THE ONSET WAS SOMEWHAT LATE, HE THINKS IT MAY BE A TASS (TOXIC ANTERIOR SEGMENT SYNDROME) CASE. HE REPORTED THAT THE PT HAS BEEN SEEN BY A CORNEAL SPECIALIST WHO SAID IT MAY BE ATYPICAL TASS. THE PT IS ON DRUG THERAPY AND BEING MONITORED. THE SURGEON STATED THAT HE IS NOT SUGGESTING THE LENS CAUSED THE EVENT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention