BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2202062 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00960
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 26, 2016
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT EVAL: LENS WAS RETURNED FOR EVAL. SOLUTION AND OPTIC DAMAGE WERE OBSERVED. HAZE WAS NOT OBSERVED ON THE LENS OTHER THAN THE REMOVAL OF THE CLINICAL SOLUTION. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED FROM THE INVESTIGATION. OTHER THAN THE REMOVAL OF THE CLINICAL SOLUTION FROM THE IOL, NO VISIBLE HAZE IS OBSERVED ON THE RETURNED PRODUCT. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED AND A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE SURGEON ON 08/03/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCED BLURRY VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED THE PT WAS CHECKED AT AN OUTPATIENT CLINIC AND BINOCULAR INTRA-OPACITY WAS NOTED. THE SURGEON REPORTED THE PT WAS HOSPITALIZED AND DIAGNOSED WITH A FOG OPACITY ON BOTH THE ANTERIOR AND POSTERIOR IOL SURFACE. ON (B)(6) 2011, THE IOL WAS REMOVED AND REPLACED AND A VITRECTOMY WAS PERFORMED. THE SURGEON REPORTED THE PT'S SYMPTOMS HAVE RESOLVED IN THIS EYE AND IT IS UNK WHAT CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE BILATERALLY IMPLANTED PT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60MA 635084

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R