BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX

    MDR report key: 2573833 · Received May 9, 2012

    Report

    Report Number
    9611165-2012-00020
    Event Type
    Other
    Date Received
    May 9, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 25, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RAYNER INTRAOCULAR LENSES LIMITED HAS BEEN ADVISED BY THE US SALES SPECIALIST THAT AN ERROR WAS MADE BY THE PHYSICIAN AT THE TIME INITIAL PATIENT BIOMETRY WAS TAKEN. AS A RESULT OF THIS ERROR, THE PHYSICIAN ORDERED AND IMPLANTED AN INTRAOCULAR LENS OF THE INCORRECT POWER. THE PHYSICIAN EXPLANTED THE C-FLEX 570C 069E9044846 +11.5D INTRAOCULAR LENS ON (B)(6) 2012. WITHIN THIS PROCEDURE THE PHYSICIAN REPLACED THE C-FLEX 570C +11.5D INTRAOCULAR LENS WITH A C-FLEX +19.0D INTRAOCULAR LENS WITH NO ADVERSE EFFECT TO THE PATIENT. A REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX 570C BATCH 069E90448 CONFIRMS THAT ALL MANUFACTURING AND QUALITY CHECKS WERE SATISFACTORY. ALL LENSES, RELEASED FROM THE C-FLEX 570C BATCH 069E90448 WERE WITHIN SPECIFICATION. COMPLAINTS SINCE JUNE 2009, THE MONTH OF MANUFACTURE, WERE REVIEWED AND WE CAN CONFIRM THAT NO OTHER COMPLAINTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE C-FLEX 570C BATCH 069E90448.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED WERE INFORMED BY THE US SALES SPECIALIST OF AN EVENT THAT OCCURRED WITH A C-FLEX 570C INTRAOCULAR LENS. THE EVENT DESCRIPTION PROVIDED BY THE US SALES SPECIALIST IS AS FOLLOWS "MISCALCULATED MEASUREMENT PATIENT GOT 11.5; NEEDED 19. DOCTOR EXCHANGED LENSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 570C 069E90448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention