BEUDAMED
    FDA Adverse Event Other Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 3214096 · Received July 3, 2013

    Report

    Report Number
    9611165-2013-00055
    Event Type
    Other
    Date Received
    July 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RAYNER MADE INITIAL CONTACT WITH ALL CUSTOMERS WHERE AFFECTED BATCHES HAD BEEN SENT IN ORDER TO DETERMINE WHETHER THE IDENTIFIED MODELS HAD BEEN USED OR REMAINED IN THEIR STOCKS. FOLLOWING COMMUNICATION WITH ALL AFFECTED CUSTOMERS RAYNER RECEIVED CONFIRMATION THAT NO LENSES RELEASED TO MARKET HAD BEEN USED. ALL LENSES IN THE POSSESSION OF CUSTOMERS WERE QUARANTINED AND RETURNED TO RAYNER. RAYNER HAS ACHIEVED 100% DEVICE RECONCILIATION. DEVICES FROM ALL AFFECTED MARKETS WERE RECONCILED IN THEIR ENTIRETY BY 24TH JUNE 2013. THE POUCH MFR HAS ATTRIBUTED A LEAK IN THE SEALING MACHINE DURING PRODUCTION AS THE ROOT CAUSE OF THE SEAL WEAKNESS. THIS EVENT HAS OCCURRED AS A RESULT OF A MFG DEFICIENCY ON THE PART OF THE POUCH SUPPLIER. RAYNER IN COLLABORATION WITH THE POUCH MFR IS WORKING TO DETERMINE A CORRECTIVE ACTION PLAN. (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2013, RAYNER INTRAOCULAR LENSES LIMITED 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 MFR'S TEST RECORDS AND TESTING OF SAMPLE POUCHES TO IDENTIFY WHICH LOTS 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 OF OUR INVESTIGATION, A PRECAUTIONARY RECALL WAS INITIATED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306410 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 623T 053E47698

    Patients

    Seq Age Sex Outcome Treatment
    1