MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
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 lens was explanted; however, the reason for iol explantation has not been specified."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device has not been returned.There is insufficient information available in this case.Rayner has requested additional information from the reporting healthcare professional to facilitate further investigation of the event.
Event or Problem Description
On 18th september 2025, rayner received notification from a us healthcare professional of an event that occurred during use of a rayone emv rao200e.The event description provided states that the lens was explanted; however, the reason for explantation has not been specified.
Event or Problem Description
On 18th september 2025, rayner received notification from a us healthcare professional of an event that occurred during use of a rayone emv rao200e.The event description provided states that the lens split during injection necessitating lens explantation.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that lens split during injection.The lens was explanted in the original surgery session."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was retained and returned to rayner for evaluation.The device was returned dehydrated in a blister tray; lens was not included in the return.Preliminary inspection of the returned injector showed that movable flaps were closed, and the plunger was pushed in.Following the full injector disassembly, cosmetic inspection of the injector parts revealed that the soft tip of the plunger was slightly bent.There were visible traces of ovd residue inside the cartridge chamber.Following this, the injector was re-assembled with new plunger, and fresh sample lens of rayone aspheric rao600c +34.00 d from rayner stock was prepared and injected in accordance with the ifu.The injection was successful, however slight resistance was experienced, and lens was delivered with an optical tear.No further testing was possible due to the damaged state of the injector.The device was returned dehydrated in a blister tray; lens was not included in the return.Preliminary inspection of the returned injector showed that movable flaps were closed, and the plunger was pushed in.Following the full injector disassembly, cosmetic inspection of the injector parts revealed that the soft tip of the plunger was slightly bent.There were visible traces of ovd residue inside the cartridge chamber.Following this, the injector was re-assembled with new plunger, and fresh sample lens of rayone aspheric rao600c +34.00 d from rayner stock was prepared and injected in accordance with the ifu.The injection was successful, however slight resistance was experienced, and lens was delivered with an optical tear.No further testing was possible due to the damaged state of the injector.Our review of production records for the rayone emv rao200e batch: 054242865 showed that all manufacturing and quality checks were conducted successfully.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch: 054242865.

• 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: 23189231
• Report Number: 3012304651-2025-00293
• Device Sequence Number: 9843431
• Product Code: HQL
• UDI-Device Identifier: 05029867006753
• UDI-Public: 05029867006753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 05/22/2026
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 054242865
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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