BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK -- IOL

    MDR report key: 2231187 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01060
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 07/28/2011 AND 08/11/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED IN FOLLOW UP PHONE CALLS ON 08/01/2011 AND 08/11/2011. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FIVE YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HE DOES NOT FEEL HIS VISION IS AS GOOD AS IT WAS AFTER HIS IMPLANTS. HE HAS RECENTLY BEEN PRESCRIBED EYE GLASSES TO IMPROVE HIS VISION. IN A FOLLOW UP PHONE CALL WITH THE PATIENT'S CURRENT OPHTHALMOLOGIST, THE OFFICE STAFF REPORTED THAT AT THE MOST RECENT VISIT, NO COMPLICATIONS OR DEFECTS WITH THE LENSES WERE REPORTED IN THE CONSUMER'S CHART. IN A FOLLOW UP PHONE CALL WITH THE IMPLANTING SURGEON'S OFFICE, IT WAS REPORTED THE CONSUMER HAS NOT BEEN SEEN SINCE 2006. HIS CHART IS ARCHIVED AND THE SURGEON'S OFFICE STATED THEY WOULD NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other