MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, rayner received notification from a us healthcare facility of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states lens explanted due to "mechanical complications".
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the lens was explanted due to "mechanical complications".The lens was implanted on (b)(6) 2026 and lens explantation was performed on (b)(6) 2026."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was not returned to rayner.Our review of production records for the rayone aspheric rao600c batch 065272695 showed that all manufacturing and quality checks were conducted with successful results.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 065272695.The healthcare facility has been contacted and asked to provide additional information to facilitate further investigation of the event.To date, no response has been received to our follow-up enquiries.Without the ability to examine the device and without clear event details being provided it is not possible to determine the root cause or nature of the "mechanical complications".

• 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: 25592681
• Report Number: 3012304651-2026-00197
• Device Sequence Number: 20258859
• Product Code: HQL
• UDI-Device Identifier: 05029867692222
• UDI-Public: 05029867692222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 065272695
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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 Sex: Unknown