MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Event or Problem Description
On 5th december 2024, rayner received notification from a us healthcare professional of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that the patient's post-operative refractive outcome was not as expected.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient's post-operative refractive outcome is not as expected.The refractive outcome post-operatively is -2.00 +0.25.The information received from the reporter states that there is minimal corneal sa (near 0.0) and pre-op had 1.1 cyl which was treated with femto arcs.Rayner has been advised that explantation of the lens is likely in this case."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.Our review of production records for the rayone emv rao200e batch 073218276 showed that all manufacturing and quality checks were conducted with successful results.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 073218276.The root cause of the refractive outcome cannot be established from the limited evidence and information available.

• Brand Name: RAYONE EMV
• Common Device Name: RAYONE EMV
• 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: 20901515
• Report Number: 3012304651-2024-00330
• Device Sequence Number: 5051587
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: (01)05029867006685
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 07/03/2025
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 073218276
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• 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