BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 2629481 · Received June 20, 2012

    Report

    Report Number
    9611165-2012-00028
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 15, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ALLOCATED TO THIS COMPLAINT BY RAYNER INTRAOCULAR LENSES LIMITED. THE PHYSICIAN EXPLANTED THE C-FLEX 570C IN THE SAME SURGERY SESSION WITH NO ADVERSE EFFECT TO THE PT. THE EXPLANTED C-FLEX 570C AND ASSOCIATED R-INJ-04 INJECTOR HAVE BEEN RETURNED TO RAYNER FOR ANALYSIS. THE ANALYSIS OF THESE DEVICES IS ONGOING. IN A PREVIOUS SIMILAR CASE REPORTED BY THE PHYSICIAN, THE CAUSE OF THE SCRATCH WAS DETERMINED TO BE A DAMAGED FORCEP USED BY THE HEALTHCARE FACILITY. A REVIEW OF PRODUCTION RECORDS OF THE C-FLEX 570C 012E32083 BATCH CONFIRMS THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED, INCLUDING COSMETIC INSPECTION, WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FROM THIS BATCH WERE WITHIN TOLERANCE AND SPECIFICATION. COMPLAINTS SINCE (B)(6) 2012, THE MONTH OF MANUFACTURE, WERE REVIEWED AND WE CAN CONFIRM THAT NO COMPLAINTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE C-FLEX 570C BATCH 012E32083.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED WERE NOTIFIED BY (B)(6) HOSPITAL OF AN INCIDENT THAT OCCURRED DURING USE OF A C-FLEX 570C INTRAOCULAR LENS. THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY IS AS FOLLOWS "SURGEON NOTICED A SCRATCH ON THE IOL AFTER IMPLANTATION. IOL EXPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES, LTD. 570C 012E32083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention