MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
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 lens did not come out of the injector correctly and once in the eye it was determined that the optic was cracked.The lens was explanted and exchanged during the original surgery session without further incident and without harm or injury to the patient."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was discarded by the healthcare facility.The rayone preloaded iol injection system use risk analysis identifies forcing a blocked injector and inadequate lubrication as possible causes of "lens optic damage".Additionally, inadequate amount of viscoelastic; inadequate quality of viscoelastic; haptic trapped by plunger override due to fast motion; user opens closed flaps and closes again before use; plunger advanced too quickly, insertion of viscoelastic through nozzle leading to inadequate amount of viscoelastic; user removed injector from tray prior to inserting viscoelastic, causing lens to be improperly placed in cartridge; user removed injector from tray prior to closing cartridge, resulting in cartridge not being clipped properly; optic edge trapped/ damaged on closure of cartridge, sharp edge instruments and dehydration of the lens prior to implantation are identified as possible causes of "trapped/torn lens haptic/optic during insertion".Our review of production records for the rayone aspheric rao600c batch 054241550 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 054241550.There is insufficient evidence and information available to determine the cause of the lens optic damage following implantation into the eye.
Event or Problem Description
On (b)(6) 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 lens did not come out of the injector correctly and once it had been implanted the optic was found to have a crack in it necessitating explantation and exchange.

• 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: 20830431
• Report Number: 3012304651-2024-00317
• Device Sequence Number: 8638578
• Product Code: HQL
• UDI-Device Identifier: 05029867692246
• UDI-Public: 05029867692246
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 05/11/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 054241550
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2024
• 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