MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 iol was "displaced".The lens was explanted and exchanged."iol decentration" is listed in the "adverse events" section of the rayone ifu.There are many predisposing conditions that increase the risk of capsular bag instability and zonular weakness including cataract surgery, prior vitreoretinal surgery, aging, axial myopia, inflammation/uveitis, trauma, retinitis pigmentosa, diabetes mellitus, atopic dermatitis, mature cataract, previous episodes of acute angle-closure attack, connective tissue disorders e.G.Pseudoexfoliation syndrome (being the most common risk factor with more than 50% of cases), marfan syndrome, homocystinuria, hyperlysinemia, ehlers-danlos syndrome, scleroderma, weill-marchesani syndrome, ectopia lentis et pupillae.Early dislocation of the lens may occur with poor fixation of the iol or capsular and/or zonular rupture during cataract surgery.Our review of production records for the rayone aspheric rao600c batch 024234409 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 024234409.There is insufficient evidence and information available to determine the cause of iol displacement.
Event or Problem Description
On 9th august 2024, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that the iol required explantation due to being "displaced".

• 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: 20124943
• Report Number: 3012304651-2024-00204
• Device Sequence Number: 16919441
• Product Code: HQL
• UDI-Device Identifier: 05029867692277
• UDI-Public: 05029867692277
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2024

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: 02/09/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 024234409
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2024
• 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