MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner, the event description provided states that post-operatively the patient was experiencing dysphotopsia.The patient underwent implantation of the rayone aspheric rao600c on (b)(6) 2025.Dysphotopsia symptoms were first reported by the patient on (b)(6) 2025.The patient elected to undergo an additional surgery to explant and exchange the lens."iol replacement or extraction" and "deviation from target refraction" are listed in the "adverse events" section of the rayone ifu.The device has not been returned to rayner.There is a period of adaptation with any intraocular lens implant referred to as neuroadaptation.Rayner has previously been advised by its medical consultants that this process can take up to six months to achieve in some patients and that some patients (approximately 1-3%) are just never able to adapt to the functional style of the lens.Our review of production records for the rayone aspheric rao600c batch 084249829 showed that all manufacturing and quality checks were conducted successfully.A review of vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone aspheric rao600c batch 084249829.The root cause of the post-operative onset of dysphotopsia cannot be established in this case; however, given time to onset it is likely that there is a neuro-adaptation factor.
Event or Problem Description
On 19th november 2025, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that post-operatively the patient experienced dysphotopsia necessitating additional surgery to explant the lens.

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE 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: 23670428
• Report Number: 3012304651-2025-00363
• Device Sequence Number: 18580320
• Product Code: HQL
• UDI-Device Identifier: 05029867692208
• UDI-Public: 05029867692208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 084249829
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female