MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd october 2025, rayner received notification from its taiwan distributor of an event that occurred during use of a rayone emv rao200e.The event description provided states that immediately following implantation into the eye a crack was observed in the optic necessitating lens explantation and exchange.
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 a crack was observed in the lens optic.The lens was explanted and exchanged during the original surgery session without further incident.There was no 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 available for return 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 rao200e batch 104254948 showed that all manufacturing and quality checks were conducted with successful results.Without the ability to examine the device and without clear event details being provided it is not possible to establish the cause of the event.
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 a crack was observed in the lens optic.The lens was explanted and exchanged during the original surgery session without further incident.There was no harm or injury to the patient."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.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 rao200e batch 104254948 showed that all manufacturing and quality checks were conducted with successful results.The device was returned dehydrated in an outer carton box; lens was placed in a saline filled pouch.Preliminary inspection of the returned injector showed that movable flaps were closed, and the plunger was pushed in.Provided lens was inspected under x10 magnification and was found to be torn in the optic area, possibly due to explantation.Following the full injector disassembly, cosmetic inspection of the injector parts revealed that the soft tip of the plunger was intact.There were visible traces of ovd residue inside the chamber.The injector was re-assembled, and 1x rayone aspheric rao600c +21.50 d from rayner's stock was prepared and injected in accordance with the ifu.The injection was successful; no issues occurred during this process.Product return inspection performed confirms the event as reported.On product return inspection and testing completed, no rayone injector fault was found.Results of injector testing confirm that the device performs as per design.
Event or Problem Description
On 2nd october 2025, rayner received notification from its taiwan distributor of an event that occurred during use of a rayone emv rao200e.The event description provided states that immediately following implantation into the eye a crack was observed in the optic necessitating lens explantation and exchange.

• 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: 23377144
• Report Number: 3012304651-2025-00312
• Device Sequence Number: 8871381
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: 05029867006685
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 104254948
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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