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

Model Number	RAO210T
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
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 surgeon identified that part of the lesn optic was missing.The lens was explanted and exchanged during 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 was not returned.The rayone preloaded iol injection system risk matrix 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.The additional information received identifies that the surgeon noticed increased resistance after he began the injection.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 at the point increased resistance was noted represents a deviation from the ifu which states injection should be discontinued.Our review of production records for the rayone emv toric rao210t batch 095281258 showed that all manufacturing and quality checks were conducted with successful results.A review of existing vigilance data confirms that this is an isolated event.No other incidents, of any type, have been reported against the rayone emv toric rao210t batch 095281258.
Event or Problem Description
On 5th may 2026, 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 when the lens was implanted into the eye a peice of lens was observed to be missing 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: 25253547
• Report Number: 3012304651-2026-00152
• Device Sequence Number: 12098538
• Product Code: HQL
• UDI-Device Identifier: 05029867022722
• UDI-Public: 05029867022722
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• 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
• Operator of Device: Health Professional
• Device Model Number: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 095281258
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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