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

Model Number	RAO210T
Medical Device Problem Codes	Scratched Material (3020); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 26th november 2025, rayner received notification from a us 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 it was observed that the lens had a torn haptic and a deep scratch across 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 the haptic was torn and the optic was observed to have a deep scratch across it.The lens was explanted and exchanged within the original surgery session."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was not 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 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.Our review of production records for the rayone emv toric rao210t batch 085279087 showed that all manufacturing and quality checks were conducted successfully.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 085279087.The additional information received identifies there was "more than normal resistance with the injector".The rayone ifu "use of rayone" section "fig 7" states "press the plunger in a slow and controlled manner.If excessive resistance is felt this could indicate a blockage; discontinue use of the product and return the product and all packaging to rayner".Continued injection of the lens after higher resistance to normal was experienced represents a deviation from the ifu and is likely the contributory/causative factor to lens damage.

• 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; 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: 23740092
• Report Number: 3012304651-2025-00382
• Device Sequence Number: 8421236
• Product Code: HQL
• UDI-Device Identifier: 05029867022364
• UDI-Public: 05029867022364
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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 Model Number: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 085279087
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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