MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number	RAO100C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd august 2025, rayner received notification from a us healthcare facility of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that post-operatively the patient has experienced persistent negative dysphotopsia necessitating 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 post-operatively the patient has experienced persistent negative dysphotopsia leading to visual impairment/visual disturbances.The patient underwent an additional surgery whereby the lens was explanted and exchanged.Rayner's medical consultants have previously advised that neuro-adaptation can take up to six months to achieve and that a small percentage of patients (approximately 3-5%) are just never able to adapt to the functional style of the lens."deviation from target refraction" and "iol replacement or extraxction" are listed in the "adverse events" section of the rayone ifu.Our review of production records for the rayone spheric rao100c batch: 074246219 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.A review of vigilance dtaa confirms this is an isolated event.No other incidents, of any type, have been received against the rayone spheric rao100c batch: 074246219.

• Brand Name: RAYONE SPHERIC
• Common Device Name: 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: 22976119
• Report Number: 3012304651-2025-00276
• Device Sequence Number: 9370329
• Product Code: HQL
• UDI-Device Identifier: 05029867692307
• UDI-Public: 05029867692307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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 Expiration Date: 07/04/2026
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 074246219
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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 Sex: Unknown