MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES RAYONE ASPHERIC

Model Number	RAO600C
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	06/10/2025
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 refractive outcome is not as expected.Plano was targeted and the patient's refraction is currently -2.50 / -0.50 x 087.The patient underwent an additional surgery whereby the rayone aspheric rao600c lens was explanted and exchanged.The healthcare facility states that the patient has made a complete recovery."deviation from target refraction" and "iol replacement or extraction" are listed in the "adverse events" section of the rayone ifu.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.The device has not been returned to rayner.Rayner iols undergo 100% optical inspection and power testing during the manufacturing process.All lenses tested within tolerance of the stated power (+25.5 d).Our review of production records for the rayone aspheric rao600c batch: 104253693 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.There is insufficient evidence and information available to determine the root cause of the deviation in the patient's post-operative refraction.
Event or Problem Description
On 1st 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 refractive outcome is not as expected.Plano was targeted and the patient's refraction is currently -2.50 / -0.50 x 087.

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• Manufacturer (Section G): RAYNER INTRAOCULAR LENSES; 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: 22782698
• Report Number: 3012304651-2025-00248
• Device Sequence Number: 18201870
• Product Code: HQL
• UDI-Device Identifier: 05029867692352
• UDI-Public: 05029867692352
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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 Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 104253693
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2024
• 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