MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED C-FLEX

Model Number	570C
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: C-FLEX
• Common Device Name: C-FLEX
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• Manufacturer (Section G): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• Manufacturer Contact: jodie neal ; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 -8AQ ; UK BN14 8AQ
• MDR Report Key: 15885744
• Report Number: 3012304651-2022-00112
• Device Sequence Number: 4913477
• Product Code: HQL
• UDI-Device Identifier: 05029867802744
• UDI-Public: (01)05029867802744
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 570C
• Device Catalogue Number: 570C
• Device Lot Number: 072E39314
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown