BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 2891589 · Received December 7, 2012

    Report

    Report Number
    1119421-2012-01519
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SCRUB TECHNICIAN WHO REPORTED THAT UPON INSERTION OF THE LENS INTO THE EYE, THE HAPTIC BROKE OFF INTO THE EYE. THE CASE WAS EXTENDED BY TWENTY MINUTES WHILE THE SURGEON RETRIEVED THE BROKEN HAPTIC AND LENS. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON CZ70BD 12142354

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR UNK VISCOELASTIC - DATE UNK