BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA, PRODUCT CODE: HQL

    MDR report key: 4611712 · Received March 11, 2015

    Report

    Report Number
    9611165-2015-00014
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Date of Event
    February 23, 2015
    Report Date
    March 10, 2015
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE HEALTHCARE PROFESSIONAL HAS INFORMED RAYNER THAT THE TRAILING HAPTIC OF THE LENS GOT CAUGHT IN THE INJECTOR DURING IMPLANTATION AND THAT UPON IMPLANTATION OF THE LENS INTO THE EYE HE OBSERVED THAT THE HAPTIC HAD BROKEN OFF. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY IN THE ORIGINAL PLANNED SURGERY SESSION. THE IOL WAS EXPLANTED THROUGH AN ENLARGED INCISION AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION USING THE BACK-UP IOL. THE DEVICE HAS NOT BEEN MADE AVAILABLE TO RAYNER FOR INSPECTION. THE INFORMATION PROVIDED TO RAYNER BY THE HEALTHCARE PROFESSIONAL SUGGESTS THAT HAPTIC BREAKAGE MAY HAVE OCCURRED AS A RESULT OF A LOADING ERROR. THE RAYNER SALES SPECIALIST WILL BE PROVIDING ADDITIONAL TRAINING TO THE USER TO PREVENT THE RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF AN UNSPECIFIED RAYNER DEVICE. THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166384 NA, PRODUCT CODE: HQL HQL RAYNER INTRAOCULAR LENSES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1