MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th june 2026, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that immediately following implantation into the eye the optic was observed to be cracked 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 optic was cracked.The lens was explanted and exchanged during the original surgery session."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.Our review of production records for the rayone aspheric rao600c batch 105284660 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 aspheric rao600c batch 105284660.Without the ability to examine the device and without clear event details being provided it is not possible to establish the root cause of the event.

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE ASPHERIC
• 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: 25577121
• Report Number: 3012304651-2026-00191
• Device Sequence Number: 5153310
• Product Code: HQL
• UDI-Device Identifier: 05029867692208
• UDI-Public: 05029867692208
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 102584660
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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