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 Impairment (2138)
Date of Event	02/04/2025
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 presented with posterior capsule opacification (pco).Iol implantation was performed on (b)(6) 2024 and pco was observed for the first time (b)(6) 2025.The patient underwent an additional surgery on an unknown date post-operatively and the capsule was yag'd.The device is not available for return, the iol remains implanted.Pco is often referred to as "secondary cataract" and is due to the migration, proliferation and differentiation of lens epithelial cells.According to the american academy of ophthalmology, pco occurs in 20-50% of patients within 2-5 years of undergoing cataract surgery.Potential risk factors include the presence of conditions such as diabetes, uveitis, myotonic dystrophy, retinitis pigmentosa and traumatic cataract.The patient in this case presented with pco just shy of two months after cataract surgery.This is too soon for typical pco and this may indicate that some other condition caused the onset of symptoms e.G., fibrin reaction.Capsular bag distension syndrome (cbds); however, this cannot be confirmed.Our review of production records for the rayone aspheric rao600c batch 023208698 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 023208698.There is insufficient evidence and information available to determine the root cause of the event.
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 posterior capsule opacification (pco) necessitating an additional surgery to yag the capsule.

• 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: 22105083
• Report Number: 3012304651-2025-00151
• Device Sequence Number: 20671766
• Product Code: HQL
• UDI-Device Identifier: 05029867692185
• UDI-Public: 05029867692185
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/29/2025

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: 02/05/2025
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 023208698
• 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: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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