MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number RAO100C

Device Problem Calcified (1077)

Patient Problem Visual Impairment (2138)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

On 17th january 2022, rayner intraocular lenses limited received notification from its (b)(6) affiliate company of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that the lens has turned cloudy post-operatively and the healthcare facility plans to explant the iol.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively the lens has been observed to have turned cloudy leading to lens explantation.The rayone spheric rao100c was explanted on (b)(6) 2022.The return of the explanted lens has been requested to enable scanning electron microscopy (sem) and energy dispersive x-ray (edx) analysis to take place.The additional information received identifies that the patient had pre-existing type 2 diabetes mellitus at the time of iol implantation.Iol implantation was performed on (b)(6) 2017 and on (b)(6) 2019 the patient underwent abalation surgery with sf6 gas.Secondary calcification affects manufacturers of hydrophilic iols 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 condition and secondary surgery with sf6 gas are likely contributory factors to the onset of the lens clouding in this case."precipitates" is listed in the "adverse events" section of the rayone hydrophilic ifu.A review of existing vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone spheric rao100c batch 027100745.

Event Description

On 17th january 2022, rayner intraocular lenses limited received notification from its german affiliate company of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that the lens has turned cloudy post-operatively necessitating lens explantation.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively the lens has been observed to have turned cloudy leading to lens explantation.The rayone spheric rao100c was explanted on (b)(6) 2022.The additional information received identifies that the patient had pre-existing type 2 diabetes mellitus at the time of iol implantation.Iol implantation was performed on (b)(6) 2017 and on (b)(6) 2019 the patient underwent abalation surgery with sf6 gas.The lens was retained post explant and returned to rayner for analysis.Following receipt of the product return, the lens was passed to the material science and toxicology team to coordinate analysis by a third-party independent laboratory.Analysis of the returned iol was completed on (b)(6) 2022.Scanning electron microscopy images analysis show a significant deposition of mineral like structures on the surface of the iol consistent with the structure and form of iol calcification.Elemental analysis of these formations by eds analysis found these structures to be formed of calcium phosphate.Analysis confirms calcification of the iol.Secondary calcification affects manufacturers of hydrophilic iols 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 condition and secondary surgery with sf6 gas are likely contributory factors to the onset of the calcification in this case."precipitates" is listed in the "adverse events" section of the rayone hydrophilic ifu.Our review of production records for the rayone spheric rao100c batch 027100745 showed that all manufacturing and quality checks were conducted with successful results.All lenses released for distribution from this batch were within tolerance, met specification criteria and were without defects.A review of existing vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone spheric rao100c batch 027100745.

• 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: 13306013
• MDR Text Key: 284877395
• Report Number: 3012304651-2022-00003
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867690587
• UDI-Public: (01)05029867690587
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2019
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 027100745
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• 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
• Treatment: ABLATION SURGERY WITH SF6 GAS; ABLATION SURGERY WITH SF6 GAS; CATARACT SURGERY & IOL IMPLANTATION; CATARACT SURGERY & IOL IMPLANTATION
• Patient Outcome(s): Required Intervention