MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number RAO100C

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

Patient Problem Visual Impairment (2138)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

On 10th august 2022, rayner intraocular lenses limited received notification from its brazilian distributor of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that post-operatively the patient presented with low visual acuity and opacification of the iol was observed.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of a rayone spheric rao100c on (b)(6) 2019.Post-operatively, the patient reported low visual acuity and on (b)(6) 2022 examination by the healthcare professional identified iol opacification.The rayone spheric rao100c was explanted on (b)(6) 2022.The patient received an alternate iol during the explantation procedure.The explanted lens has been retained and is being returned to rayner to undergo structural and ultrastructural analysis (scanning electron microscopy - sem and energy dispersive x-ray fluorescence spectroscopy - edx).Rayner has requested additional information from the reporter, including patient medical history, to facilitate further investigation of the event.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 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.

Event Description

On 10th august 2022, rayner intraocular lenses limited received notification from its brazilian distributor of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that post-operatively the patient presented with low visual acuity and opacification of the iol was observed necessitating explantation of the iol.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of a rayone spheric rao100c on 21st may 2019.Post-operatively, the patient reported low visual acuity and on 20th june 2022 examination by the healthcare professional identified iol opacification.The patient medical history received identifies that the patient has diabetes mellitus and is prescribed metformin.The rayone spheric rao100c was explanted on 23rd june 2022.The patient received an alternate iol during the explantation procedure.The explanted lens has been retained and was returned to rayner for evaluation.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)).Device analysis was completed on 30th september 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.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 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.As identified in published literature the patient's pre-existing medical condition may be a contributory factor to the onset of post-operative calcification in this case; however, it is not possible to confirm.

• Brand Name: RAYONE SPHERIC
• Type of Device: RAYONE SPHERIC
• 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: 15258546
• MDR Text Key: 304975831
• Report Number: 3012304651-2022-00047
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867690624
• UDI-Public: (01)05029867690624
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 019130606
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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 Sex: Male