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

Model Number 570C

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

Patient Problem Visual Impairment (2138)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

On 18th april 2022, rayner intraocular lenses limited received notification from its braziian distributor of an event that occurred following implantation of a c-flex 570c iol.The event description provided states that post-operatively the patient complained of low visual acuity and examination of the right eye identified opacification of the iol.

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 the right eye on (b)(6) 2017.Post-operatively, the patient complained of low visual acuity.Iol opacification was observed for the first time on (b)(6) 2020.The patient medical history received identifies that the patient has arterial hypertension.The patient has recently complained of further decline in their visual acuity and the healthcare professional has decided to explant the lens.Explantation is scheduled for (b)(6) 2022.Rayner has requested the return of the explanted iol for structural and ultrastructural analysis (scanning electron microscopy (sem) and energy dispersive x-ray fluorescence (edx) spectroscopy).Analysis will be completed by a third-party independent laboratory and the results will be provided in a follow-up report.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.Secondary calcification affects many manufacturers and is a phenomenon that is not fully understood; it is known that it stemsfrom 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.

Manufacturer Narrative

The reference c22185 has been allocated to this case by rayner.The patient underwent implantation of the c-flex 570c iol in the right eye on (b)(6) 2017.Post-operatively, the patient complained of low visual acuity.Iol opacification was observed for the first time on (b)(6) 2020.The patient medical history received identifies that the patient has arterial hypertension.The patient has recently complained of further decline in their visual acuity and the healthcare professional has decided to explant the lens.Explantation took place on (b)(6) 2022.The explanted lens was returned.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)).Analysis was completed on (b)(6) 2022.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.Secondary calcification affects many manufacturers and is a phenomenon that is not fully understood; it is known that it stemsfrom 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.Device analysis confirms calcification of the iol; however, the root cause for post-operative calcification has not been established.

Event Description

On (b)(6) 2022, rayner intraocular lenses limited received notification from its braziian distributor of an event that occurred following implantation of a c-flex 570c iol.The event description provided states that post-operatively the patient complained of low visual acuity and examination of the right eye identified opacification of the iol.

• Brand Name: C-FLEX
• Type of Device: 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: 14186926
• MDR Text Key: 289882296
• Report Number: 3012304651-2022-00019
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867045769
• UDI-Public: (01)05029867045769
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: 570C
• Device Catalogue Number: 570C
• Device Lot Number: 037103778
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• 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: 75 YR
• Patient Sex: Female