BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2489299 · Received March 9, 2012

    Report

    Report Number
    9611165-2012-00011
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 7, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. RAYNER INTRAOCULAR LENSES LIMITED HAVE BEEN INFORMED THAT THE PT HAS A "VERY SPECIFIC PROFILE" AND FURTHER INFO HAS BEEN REQUESTED TO DETERMINE IF THE PROFILE OF THE PT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEVELOPMENT OF SUSPECTED OPACIFICATION. VERY LIMITED INFO IS AVAILABLE AT THE TIME OF WRITING THIS INITIAL REPORT AND CONTACT HAS BEEN MADE WITH THE HEALTHCARE FACILITY TO FULLY INVESTIGATE THE REPORTED EVENT. THE RETENTION AND RETURN OF THE DEVICE HAS BEEN REQUESTED. UPON RECEIPT OF THE INTRAOCULAR LENS, IT WILL BE SENT TO AN INDEPENDENT TESTING FACILITY FOR ANALYSIS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED WERE NOTIFIED OF THE DEVELOPMENT OF SUSPECTED OPACIFICATION IN A PT THOUGHT TO BE FITTED WITH A RAYNER INTRAOCULAR LENS. THE PHYSICIAN HAS INFORMED RAYNER THAT OPACIFICATION OCCURRED FOLLOWING A COMBINED PHACO AND VITRECTOMY PROCEDURE. THE PHYSICIAN¿S INTENTION IS TO EXPLANT THE OPACIFIED INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HQL-INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention