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

Model Number 970C

Device Problems Calcified (1077); Material Opacification (1426)

Patient Problem Visual Impairment (2138)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

On 29th november 2021, rayner intraocular lenses limited received notification from its (b)(6) distributor of an event that occurred following implantation of a c-flex aspheric 970c iol.The event description provided states that three months post-operatively opacification of the iol was observed.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that three months following iol implantation the patient presented with opacification of the iol.The patient medical history received states that the patient has diabetic retinopathy and six months prior to iol implantation the patient underwent surgery for diabetic retinal detachment during which silicone oil was inserted into the eye.Six months following retinal detachment surgery, silicone oil was removed from the eye and on (b)(6) 2021 the c-flex aspheric 970c iol was implanted.Opacification was observed for the first time on (b)(6) 2021.On an unknown date post-operatively, the c-flex aspheric 970c iol was explanted.The explanted lens has been retained and will be returned to rayner for analysis.The lens will be sent to a third-party independent laboratory to undergo scanning electron microscopy (sem) and electron dispersive x-ray fluorescence spectroscopy (edx).The results of the analysis will be shared in a follow-up report.Rayner ifus contraindicate "· active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication")."precipitates" is listed in the "adverse events" section of the ifu.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.The patient's pre-existing medical history is likely a contributory factory to the onset of opacification in this case.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that three months following iol implantation the patient presented with opacification of the iol.The patient medical history received states that the patient has diabetic retinopathy and six months prior to iol implantation the patient underwent surgery for diabetic retinal detachment during which silicone oil was inserted into the eye.Six months following retinal detachment surgery, silicone oil was removed from the eye and on (b)(4) 2021 the c-flex aspheric 970c iol was implanted.Opacification was observed for the first time on 28th october 2021.On an unknown date post-operatively, the c-flex aspheric 970c iol was explanted.The explanted lens 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)).Sem and eds analysis revealed a significant deposition of mineral like structures on the surface of the iol consistent with the structure and form of iol calcification.The crystals were composed of calcium phosphate.The calcification of iols has been categorised in published literature into two types; primary and secondary (plus a third for those incorrectly determined cases).Primary calcification is inherent.It is due to particular manufacturing processes or packaging interactions.An examination of the literature shows that some manufacturers have had known cases of primary calcification due to an interaction with silicone in the packaging - and more recently, due to phosphate remnants (originating from a detergent) found in the manufacturing process.Rayner has made no material processing or packaging changes that may have negatively affected our iols; we have never had a confirmed case of primary calcification relating to a rayner iol.Rayner ifus contraindicate " active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication")."precipitates" is listed in the "adverse events" section of the ifu.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.The patient's pre-existing medical history is likely the causative/contributory factor leading to the onset of calcification in this case.

Event Description

On (b)(6) 2021, rayner intraocular lenses limited received notification from its brazilian distributor of an event that occurred following implantation of a c-flex aspheric 970c iol.The event description provided states that three months post-operatively opacification of the iol was observed.

• Brand Name: C-FLEX ASPHERIC
• Type of Device: C-FLEX ASPHERIC
• 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: 12974468
• MDR Text Key: 285339600
• Report Number: 3012304651-2021-00054
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867252761
• UDI-Public: (01)05029867252761
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 970C
• Device Catalogue Number: 970C
• Device Lot Number: 116E93990
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male