BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX

    MDR report key: 15885744 · Received November 30, 2022

    Report

    Report Number
    3012304651-2022-00112
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 14, 2022
    Report Date
    February 21, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867802744
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PATIENT UNDERWENT IMPLANTATION OF THE C-FLEX 570C IOL IN THEIR RIGHT EYE PRIOR TO 2015. THE PATIENT MEDICAL HISTORY RECEIVED IDENTIFIES THAT THE PATIENT HAS DIABETES AND PRIMARY OPEN ANGLE GLAUCOMA, CATEGORISED AS SEVERE. IOL IMPLANTATION WAS NOT COMBINED WITH ANY OTHER OCULAR SURGERY; HOWEVER, THE PATIENT IS REPORTED TO HAVE REQUIRED MULTIPLE SURGERIES IN THE POST-OPERATIVE PERIOD, AS DETAILED BELOW: ON (B)(6) 2016: AHMED AQUEOUS SHUNT IMPLANTATION, TUTOPLAST GRAFT, RIGHT EYE, PRIMARY OPEN ANGLE. ON (B)(6) 2019: BAERVELDT AQUEOUS SHUNT IMPLANTATION, LEFT EYE, PRIMARY OPEN-ANGLE GLAUCOMA. ON (B)(6) 2019: SCLERAL REINFORCEMENT WITH PATCH GRAFT, LEFT EYE, PRIMARY OPEN-ANGLE GLAUCOMA. RAYNER IFUS CONTRAINDICATE "ACTIVE OCULAR DISEASES (E.G., CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION". IOL OPACIFICATION WAS OBSERVED FOR THE FIRST TIME ON (B)(6) 2017 AND WAS ASSESSED AS BEING PROGRESSIVE IN NATURE. OPACIFICATION LED TO A DECLINE IN PATIENT VISUAL ACUITY AND THE C-FLEX 570C IOL WAS EXPLANTED ON (B)(6) 2022. THE EXPLANTED LENS WAS RETAINED AND RETURNED TO RAYNER FOR EVALUATION. THE EXPLANTED IOL WAS SENT TO A THIRD-PARTY INDEPENDENT LABORATORY TO UNDERGO STRUCTURAL AND ULTRASTRUCTURAL ANALYSIS (SCANNING ELECTRON MICROSCOPY (SEM) AND ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS)). DEVICE ANALYSIS WAS COMPLETED ON 3RD FEBRUARY 2023. COMPREHENSIVE SEM AND EDS ANALYSIS DID NOT REVEAL ANY EVIDENCE OF CALCIUM PHOSPHATE MINERAL DEPOSITION ON THE LENS. ANALYSIS REVEALED THAT CARBON (C) AND OXYGEN (O) WERE THE MAIN ELEMENTS OF THE SAMPLE, CONSISTENT WITH THE MATERIAL OF THE ACRYLIC IOL. THE IOL ANALYSIS CONCLUDED THAT THERE IS NO CALCIFICATION OF THE IOL. IT IS NOT POSSIBLE FROM THE ANALYSIS PERFORMED TO DETERMINE THE ROOT CAUSE OF THE REPORTED PROGRESSIVE OPACIFICATION IN THIS CASE; HOWEVER, IT IS POSSIBLE TO EXCLUDE A LENS RELATED CAUSE.

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PATIENT UNDERWENT IMPLANTATION OF THE C-FLEX 570C IOL IN THEIR RIGHT EYE PRIOR TO 2015. THE PATIENT MEDICAL HISTORY RECEIVED IDENTIFIES THAT THE PATIENT HAS DIABETES AND PRIMARY OPEN ANGLE GLAUCOMA, CATEGORISED AS SEVERE. IOL IMPLANTATION WAS NOT COMBINED WITH ANY OTHER OCULAR SURGERY; HOWEVER, THE PATIENT IS REPORTED TO HAVE REQUIRED MULTIPLE SURGERIES IN THE POST-OPERATIVE PERIOD, AS DETAILED BELOW: (B)(6) 2016: AHMED AQUEOUS SHUNT IMPLANTATION, TUTOPLAST GRAFT, RIGHT EYE, PRIMARY OPEN ANGLE (B)(6) 2019: BAERVELDT AQUEOUS SHUNT IMPLANTATION, LEFT EYE, PRIMARY OPEN-ANGLE GLAUCOMA (B)(6) 2019: SCLERAL REINFORCEMENT WITH PATCH GRAFT, LEFT EYE, PRIMARY OPEN-ANGLE GLAUCOMA IOL OPACIFICATION WAS OBSERVED FOR THE FIRST TIME ON (B)(6) 2017 AND WAS ASSESSED AS BEING PROGRESSIVE IN NATURE. OPACIFICATION LED TO A DECLINE IN PATIENT VISUAL ACUITY AND THE C-FLEX 570C IOL WAS EXPLANTED ON (B)(6) 2022. RAYNER HAS REQUESTED THE RETURN OF THE EXPLANTED IOL FOR ANALYSIS. SECONDARY CALCIFICATION AFFECTS MANY MANUFACTURERS AND IS A PHENOMENON THAT IS NOT FULLY UNDERSTOOD; IT IS KNOWN THAT IT STEMS FROM CHANGES IN THE EYE'S ENVIRONMENT DUE TO PATIENT COMORBIDITY, SECONDARY SURGERIES AND POTENTIALLY OTHER, POORLY UNDERSTOOD INTERACTIONS: OFF LABEL USE OF INTRACAMERAL ALTEPLASE (ACTILYSE) (RTPA), MULTIFACTORIAL, HIGH PHOSPHATE CONTENT OPHTHALMIC VISCOELASTIC DEVICES , REPEATED EXPOSURE TO INTRACAMERAL AIR, RAISED INTRAOCULAR PRESSURE, EXCESSIVE POST-OPERATIVE INFLAMMATION, COMPLICATED, TRAUMATISED EYES, AS A RESULT OF DIRECT CONTACT BETWEEN THE IOL SURFACE AND THE EXOGENOUS GAS OR SUBSTANCE, A METABOLIC CHANGE IN THE ANTERIOR CHAMBER DUE TO THE PRESENCE OF EXOGENOUS GAS/SUBSTANCE IN THE EYE OR AN EXACERBATED INFLAMMATORY REACTION AFTER MULTIPLE SURGICAL PROCEDURES, TRAUMA OR REPEAT SURGERY INVOLVED IN RE-BUBBLING POTENTIALLY DISRUPTING THE BLOOD AQUEOUS BARRIER, INCREASING CONCENTRATION OF CALCIUM IONS. RAYNER IFUS CONTRAINDICATE "ACTIVE OCULAR DISEASES (E.G., CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION". THE PATIENT'S MEDICAL HISTORY AND REPEAT OCULAR PROCEDURES FOR THE TREATMENT OF THEIR PRE-EXISTING MEDICAL CONDITIONS IS LIKELY TO BE A CONTRIBUTORY FACTOR TO THE ONSET OF OPACIFICATION IN THIS CASE.

    Description of Event or Problem · 0

    ON 17TH NOVEMBER 2022, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX 570C IOL. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE ONSET OF IOL OPACIFICATION HAS BEEN OBSERVED LEADING TO EXPLANTATION OF THE IOL.

    Description of Event or Problem · 0

    ON (B)(6) 2022, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX 570C IOL. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE ONSET OF IOL OPACIFICATION HAS BEEN OBSERVED LEADING TO EXPLANTATION OF THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574467 C-FLEX C-FLEX HQL RAYNER INTRAOCULAR LENSES LIMITED 570C 072E39314 05029867802744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention