MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV TORIC

Model Number	RAO210T
Medical Device Problem Code	Scratched Material (3020)
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 immediately following implantation into the eye the lens was observed to be scratched.The lens was explanted and exchanged during the original surgery session without any harm or injury to the patient."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was not returned to rayner.The rayner hydrophilic acrylic iol use risk analysis identifies the following as possible causes of "physical damage to lens"; sharp edge instruments used during surgical procedure, surgical procedure: incorrect use of lens injection system, surgeon misidentifying posterior capsule creasing, lens surface ablated by nd: yag operator error and cracked optic surface post injection due to dehydration of lens.Additionally, the rayone preloaded iol injection system use risk analysis identifies forcing a blocked injector, inadequate lubrication, misuse of device and optic edge trapped/damaged on closure of cartridge as possible causes of lens optic damage.Our review of production records for the rayone emv toric rao210t batch 026291874 showed that all manufacturing and quality checks were conducted with successful results.A review of vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone emv toric rao210t batch 026291874.Without the ability to examine the device and without clear event details being provided it is not possible to determine the cause of the event.
Event or Problem Description
On (b)(6) 2026, rayner received notification from a uk healthcare facility of an event that occurred during use of a rayone emv toric rao210t.The event description provided states that immediately following implantation into the eye the lens was scratched necessitating lens explantation and exchange.

• Brand Name: RAYONE EMV TORIC
• Common Device Name: RAYONE EMV TORIC
• 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: 25253543
• Report Number: 3012304651-2026-00151
• Device Sequence Number: 10512011
• Product Code: HQL
• UDI-Device Identifier: 05029867022364
• UDI-Public: 05029867022364
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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
• Device Model Number: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 026291874
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• 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