MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE

Model Number NOT AVAILABLE

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

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that the lens was explanted approximately 10 years following implantation due to the onset of opacification.The healthcare facility that explanted the iol has been unable to provide any product identifying information.The limited information received states that the patient has no corneal endothelial issues, iol surgery was not combined with other surgery, there has been no prior air/gas in the eye, no alteplase and the onset was approximately 6-12 months ago.The patient was referred to the reporting healthcare professional 3 months ago.The explanted iol has been retained and is being returned to rayner for analysis.The lens will be sent to a third party independent laboratory to undergo scanning electron microscopy (sem) and energy dispersive x-ray fluorescence spectroscopy (edx).

Event Description

On 10th june 2022, rayner intraocular lenses limited received notification from its australian affiliate company of an event that occurred following implantation of an unspecified rayner iol.The event description provided states that approximately 10 years after iol implantation the lens was explanted due to the onset of opacification.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that the lens was explanted approximately 10 years following implantation due to the onset of opacification.The healthcare facility that explanted the iol has been unable to provide any product identifying information.The limited information received states that the patient has no corneal endothelial issues, iol surgery was not combined with other surgery, there has been no prior air/gas in the eye, no alteplase and the onset was approximately 6-12 months ago.The patient was referred to the reporting healthcare professional 3 months ago.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)).Device 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 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.Our rate of secondary calcification remains extremely low.From the sem and eds analysis performed, and without the patient's medical/ surgical history being provided it has not been possible to determine the root cause of the development of iol opacification in this case.There is no evidence of a causal relation between the event and the rayner device.

Event Description

On (b)(6) 2022, rayner intraocular lenses limited received notification from its australian affiliate company of an event that occurred following implantation of an unspecified rayner iol.The event description provided states that approximately 10 years after iol implantation the lens was explanted due to the onset of opacification.

• Brand Name: NOT AVAILABLE
• Type of Device: NOT AVAILABLE
• 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: 14841016
• MDR Text Key: 302945033
• Report Number: 3012304651-2022-00039
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• 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