MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 28th august 2025, 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 that post-operatively the patient presented with a refractive surprise.
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 a refractive surprise.The patient underwent implantation of the rayone aspheric rao600c on (b)(6) 2025.Refractive surprise was reported on (b)(6) 2025.The patient underwent an additional surgery whereby the lens was explanted and exchanged.The healthcare facility confirms there was no harm or injury to the patient and states that the patient has completely recovered."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 are many factors which may influence the post-operative outcome of the patient including but not limited to; incomplete removal of ovd following iol implantation (capsular block/capsular bag distension syndrome), dry eye during biometry measurement, incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), incorrect power selection (not using optimised a-constants may be a contributory factor in this scenario - surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.), posterior synechiae, irregular capsular bag contraction, patient medical history (e.G., glaucoma, pseudoexfoliation syndrome), lens decentration or dislocation, incorrect or unstable fixation within the capsular bag, post-operative rotation of the lens, lens does not fit anatomy of the eye (e.G., too large or too small), capsulorhexis diameter too large and induced surgical astigmatism.Our review of production records for the rayone aspheric rao600c batch 054243655 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.Without the ability to examine the device and without clear event details being provided it is not possible to establish the cause of the reported refractive surprise.

• 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: 22990124
• Report Number: 3012304651-2025-00281
• Device Sequence Number: 8868722
• Product Code: HQL
• UDI-Device Identifier: 05029867692321
• UDI-Public: 05029867692321
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 05/30/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 054243655
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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