MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Visual Disturbances (2140)
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 the patient didn't like the visual acuity targeted by the surgeon in the intiial surgery and had requested a lens exchange to change her near-sightedness to fairsightedness (for plano rather than -2.0).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.There is no evidence nor suggestion of the patient's post-operative refraction being device related, simply that the outcome targeted by the surgeon did not meet the patient's expectations.Our review of production records for the rayone aspheric rao600c batch 054241590 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 aspheric rao600c batch 054241590.
Event or Problem Description
On 31st october 2024, 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 the patient wants to undergo a lens exchange to correct her near-sightedness to fair-sightedness.

• 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: 20784416
• Report Number: 3012304651-2024-00305
• Device Sequence Number: 13013218
• Product Code: HQL
• UDI-Device Identifier: 05029867800047
• UDI-Public: 05029867800047
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 05/08/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 054241590
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 59 YR
• Patient Sex: Female