BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERFLEX

    MDR report key: 3244186 · Received July 15, 2013

    Report

    Report Number
    3003563511-2013-00012
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    July 12, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN (B)(4) 2013, RAYNER INTRAOCULAR LENSES LTD, (B)(4) IDENTIFIED A POTENTIAL WEAKNESS OF THE OUTER PAPER POUCH CHEVRON SEAL USED TO ENCASE THE PRIMARY PACK (THE IOL BLISTER POUCH). RAYNER DETERMINED THAT AS A RESULT OF THIS WEAKNESS THE STERILITY OF THE PRIMARY PACK MAY BE COMPROMISED. AN INVESTIGATION WAS PERFORMED BY RAYNER TO DETERMINE THE EXTENT OF THE ISSUE IN ORDER TO IDENTIFY THE SPECIFIC POUCH RANGE AFFECTED. THIS INCLUDED A REVIEW OF THE POUCH MANUFACTURER'S TEST RECORDS AND TESTING OF SAMPLE POUCHES TO IDENTIFY WHICH LOT'S WERE OUTSIDE OF THE DEFINED ACCEPTANCE PARAMETERS. POUCH PACKETS TESTED AND FOUND TO BE OUTSIDE OF ACCEPTANCE PARAMETERS WERE QUARANTINED AND USING PRODUCTION RECORDS DEVICE HISTORY RECORDS ALL POTENTIALLY AFFECTED PRODUCT WAS IDENTIFIED. THIS DATA WAS THEN USED TO CALCULATE THE TOTAL NUMBER OF PRODUCT PACKED IN THE AFFECTED POUCH PACKETS AND RELEASED TO MARKET. AS A RESULT OF THE FINDINGS, A PRECAUTIONARY RECALL WAS INITIATED BY RAYNER IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327500 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 620H 053E47255

    Patients

    Seq Age Sex Outcome Treatment
    1