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	Intraocular Pressure Increased (1937)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 13th may 2025, rayner received notification from a us healthcare professional of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that post-operatively the patient presented with an elevated pressure of 39mmhg.
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 presented with increased intraocular pressure.Iol implantation was performed on (b)(6) 2025 and the patient presented with an elevated pressure of 39mmhg on (b)(6) 2025.The patient underwent an additional surgery and wound burp (aqueous tap or paracentesis) was performed.Increased intraocular pressure is a recognised complication of cataract surgery identified within published literature (ref.Https://eyewiki.Org/cataract_surgery_complications)."active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication") are contraindicated in rayner ifus."secondary glaucoma" and "reduced vision" are listed in the "adverse events" section of the rayone ifu.The rayone ifu also includes the "warning" "surgical difficulties at the time of cataract extraction which might increase the potential for complications (e.G.Persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss)".Our review of production records for the rayone aspheric rao600c batch 034237072 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 data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone aspheric rao600c batch 034237072.There is no evidence or information to suggest a causal relation between the event and the rayner device.The root cause cannot be determined.

• 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: 22121963
• Report Number: 3012304651-2025-00154
• Device Sequence Number: 17880410
• Product Code: HQL
• UDI-Device Identifier: 05029867692031
• UDI-Public: 05029867692031
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 034237072
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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