BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSO

    MDR report key: 3040095 · Received April 3, 2013

    Report

    Report Number
    9612169-2013-00012
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ALCON LABORATIORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADD'L OBSERVATIONS WERE AS FOLLOWS: LENS RETURNED IN TWO (2) PIECES IN #78 (IW) LENS CASE. SOLUTION IS DRIED ON THE LENS. ONE HAPTIC IS BROKEN/TORN/MISSING AT THE GUSSET AREA. THE OPTIC IS BROKEN/TORN POSSIBLY CUT, AND SCRATCHED/MARKED - REJECTABLE. ROOT CAUSE: WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THAT IT IS NOT MFG RELATED. DUE TO THE CONDITION OF THE RETURNED LENS, THE DAMAGE IS MOST LIKELY CAUSED BY THE CUSTOMER AND IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE EVENT. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL WAS DIVIDED IN TOW PIECES WHEN INJECTED IN THE EYE AND THE HAPTIC WAS MISSING. THE INCISION WAS ENLARGED IN ORDER TO REMOVE THE IOL. NO SUTURES WERE NEEDED. THERE WAS A DELAY OF 20 MINUTES. IN SURGEON'S OPINION, THIS DELAY WAS CONSIDERED AS CLINICALLY SIGNIFICANT. ADD' L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135937 ACRYSO INTRAOCULAR LENS HQL ALCON LABORATIORIES IRELAND LTD. SN60WF 21070022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention