MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number	RAO100C
Medical Device Problem Code	Scratched Material (3020)
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 immediately following implantation into the eye the lens was identified to be scratched.The lens was explanted and exchanged during the original surgery session without further incident."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was discarded by the healthcare facility.The rayner hydrophilic acrylic iol use risk matrix 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 matrix 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.The additional information received identifies that the surgeon does not use ovd and instead uses a hydroimplantation technique.The ifu states "rayner recommends that saline is not used as the sole lubricating agent, but in combination with a viscoelastic solution.The use of a sodium hyaluronate-based viscoelastic is recommended." our review of production records for the rayone spheric rao100c batch 095280275 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 spheric rao100c batch 095280275.The lack of ovd use, a deviation from the ifu, may be a contributory and/or causative factor to the lens damage in this case.
Event or Problem Description
On 12th february 2026, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone spheric rao100c.The event description provided states that immediately following implantation into the eye the lens was observed to be scratched necessitating lens explantation and exchange.

• Brand Name: RAYONE SPHERIC
• Common Device Name: RAYONE SPHERIC
• 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: 24399557
• Report Number: 3012304651-2026-00057
• Device Sequence Number: 8299629
• Product Code: HQL
• UDI-Device Identifier: 05029867689680
• UDI-Public: 05029867689680
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 095280275
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2025
• 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