BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 12313074 · Received August 12, 2021

    Report

    Report Number
    3012304651-2021-00032
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Report Date
    August 12, 2021
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT CLOUDING WITHIN THE LENS WAS OBSERVED WITHIN THE POST-OPERATIVE PERIOD NECESSITATING AN ND:YAG LASER CAPSULOTOMY. TYPICALLY, CASES OF OPACIFICATION WHICH OCCUR WITHIN THE LENS MATERIAL RESULT IN LENS EXPLANTATION AS ALL OTHER MEANS OF SURGICAL INTERVENTION CANNOT RESOLVE THE OPACIFICATION AND/OR IMPROVE THE PATENT'S VISUAL OUTCOME. THE SUCCESS OF THE YAG PROCEDURE IN THIS CASE SUGGESTS THAT THE ONSET OF VISUAL CLOUDING MAY BE ATTRIBUTABLE TO SOME OTHER (NON-LENS RELATED) FACTOR, SUCH AS FIBROSIS, FIBRIN REACTION, ANTERIOR CAPSULE CONTRACTION SYNDROME (ACCS), OR CAPSULAR BAG DISTENSION SYNDROME (CBDS). IN FOLLOW-UP WITH RAYNER, THE HEALTHCARE PROFESSIONAL PROVIDED THE BELOW ADDITIONAL INFORMATION: "SHE IS A (B)(6) YEAR OLD LADY WHO I PERFORMED UNCOMPLICATED CATARACT SURGERY ON HER LEFT EYE AND IMPLANTED A RAYNER EMV RAO200E IOL. I TARGETED HER FOR NEAR VISION SINCE SHE UNDERWENT LASIK SURGERY YEARS AGO WITH MONOVISION. YEARS AGO I PERFORMED CATARACT SURGERY ON HER RIGHT EYE AND TARGETED DISTANCE VISION, SHE HAS BEEN FINE SINCE THAT SURGERY. HER LEFT EYE HAD NUCLEAR COMPONENT AND A CLOUDING OF HER POSTERIOR CAPSULE THAT I WAS UNABLE TO CLEAR AT THE TIME OF SURGERY. THE FIRST DAY POSTOP THE IOL LOOK FINE AS ALL THE OTHER RAYNER RAO600C AND RAO200E I HAVE IMPLANTED. HER POSTOP MEDICATIONS WERE PRED-GATI-BROM FROM IMPRIMIS. AT TWO WEEKS POSTOP , HER NORMAL INFLAMMATION HAD CLEARED. SHE COMPLAINED HER VISION WAS LIKE "PRIOR TO HER YAG LASER" CAPSULOTOMY IN HER RIGHT EYE. HER POSTERIOR CAPSULE HAD THE SAME HAZE AS IT DID AT THE TIME OF SURGERY. WE DECIDED TO PERFORM A YAG LASER CAPSULOTOMY AT SIX WEEKS POSTOP TO IMPROVE HER VISION. SHE CAME IN FOR CAPSULOTOMY AND HER IMPLANT WAS CLOUDY IN THE OPTIC MATERIAL. THE CENTER WAS SPARED , AND THE " CENTRAL ELEVATION" ON THE RAO200E WAS CLEARLY VISIBLE. WE DECIDED TO PERFORM THE YAG CAPSULOTOMY SINCE HER VISION WAS GOOD, BUT SHE WANTED BETTER CLARITY. I THINK SHE MAY HAVE HAD A "SMALL APERATURE IOL" EFFECT. ONE WEEK AFTER THE UNCOMPLICATED YAG CAPSULOTOMY HER VISION HAD IMPROVED AND SHE WAS J1+ UNCORRECTED. UNFORTUNATELY, I DID NOT TAKE A SLIT LAMP PHOTO OF THE IOL. ALSO, SHE IS MOVING TO (B)(6) THIS WEEK, SO I WON'T HAVE ANY MORE FOLLOWUP WITH HER. IN TERMS OF COMORBIDITIES: SHE HAS NONE OF THOSE LISTED. SHE WAS USING TOPICAL RESTASIS PRIOR TO SURGERY AND AFTER AS HER ONLY OTHER OCULAR MEDICATIONS". IN THE ABSENCE OF THE LENS FOR RETURN AND WITHOUT SLIT LAMP PHOTOGRAPHS BEING AVAILABLE RAYNER IS UNABLE TO COMMENT FURTHER ON THE ONSET AND/OR PRESENTATION OF LENS CLOUDING IN THIS CASE. THE HEALTHCARE PROFESSIONAL STATES THAT THE PATIENT HAD A NUCLEAR COMPONENT AND CLOUDING OF THE POSTERIOR CAPSULE THAT COULD NOT BE CLEARED AT THE TIME OF SURGERY AND THIS IS A POSSIBLE CONTRIBUTORY FACTOR TO LENS CLOUDING IN THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, RAYNER INTRACULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT CLOUDING WITHIN THE LENS WAS OBSERVED WITHIN THE POST-OPERATIVE PERIOD NECESSITATING AN ND:YAG LASER CAPSULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209619 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 021164265

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention