MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th november 2025, rayner received notification from a us healthcare facility of an event that occurred following impalntation of a rayone aspheric rao600c.The event description provided states that the patient is experiencing post-operative negative dysphotopsia and required an additional surgery to explant and exchange the lens.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that approximately one month post-operatively the patient reported with complaints of visual impairment/visual disturbance.The healthcare facility determined that the patient was experiencing post-operative negative dysphotopsia.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 045268582 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 045268582.Given the time to onset, it is most likely that the negative dysphotopsia experienced by the patient in this case is attributable to failure to and/or delayed neuro-adaptation.

• 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: 23629147
• Report Number: 3012304651-2025-00357
• Device Sequence Number: 15775556
• Product Code: HQL
• UDI-Device Identifier: 05029867692215
• UDI-Public: 05029867692215
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 045268582
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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