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

Model Number	RAO210T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/31/2026
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 the lens came out of the injector very quickly and ruptured the posterior capsule.The lens was explanted and replaced with a 3-piece iol without further incident during the original surgery session.Patient not fully recovered on day of report; however, a full recovery is anticipated."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The subject device was discarded by the healthcare facility.The rayone preloaded iol injection system risk matrix identifies plunger advances too quickly and forcing a blocked injector as possible causes of "explosive expulsion of lens".Our review of production records for the rayone emv toric rao210t batch 075275915 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 075275915.There is insufficient evidence and information available to determine the root cause of the event.
Event or Problem Description
On 31st march 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 the lens came out of the injector very quickly and ruptured the posterior capsule.

• 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: 24842830
• Report Number: 3012304651-2026-00117
• Device Sequence Number: 14900456
• Product Code: HQL
• UDI-Device Identifier: 05029867022333
• UDI-Public: 05029867022333
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 075275915
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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