MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 25th september 2024, rayner received notification from a healthhcare facility in france of an event that occurred during use of a rayone emv rao200e.The event description provided states that the lens was torn during implantation necessitating explantation of the iol.
Additional Manufacturer Narrative
The reference: (b)(4) has been allocated to this case by rayner.The event description provided states that the lens tore in the patient's eye, necessitating explantation and exchange.The iol was explanted and exchanged during the original surgery session; however, the back-up lens failed to deliver into the eye (see (b)(4) - fda mdr 3012304651-2024-00270).A third lens was implanted successfully within the original surgery session without harm or injury to the patient."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device has not been returned to rayner.The rayone preloaded iol injection system use risk analysis identifies the following as possible causes of "trapped/torn lens haptic/optic during insertion"; 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 removes injector from tray prior to closing cartridge - resulting in cartridge not being clipped closed properly and optic edge trapped/damaged on closure of cartridge.Our review of production records for the rayone emv rao200e batch: 044238547 showed that all manufacturing and quality checks were conducted with successful results.There is insufficient evidence and information available in this case to establish the cause of the damage to the lens occurred during implantation.

• 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: 20395175
• Report Number: 3012346512-2024-00269
• Device Sequence Number: 8038188
• Product Code: HQL
• UDI-Device Identifier: 05029867006722
• UDI-Public: 05029867006722
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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 Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 044238547
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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