MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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 the lens was scratched.The iol was explanted and exchanged during the original surgery session.The device was not available for return, it was discarded by the healthcare facility."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The rayner hydrophilic acrylic iol use risk analysis 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, phsyical damage to lens, lens surface ablated by nd:yag operator error and cracked optic surface due to dehydration of lens.Our review of production records for the rayone aspheric rao600c batch 064245882 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.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 064245882.Without the ability to examine the device and without clear event details being provided it is not possible to determine the cause the scratch observed on the optic immediately following implantation.
Event or Problem Description
On 17th december 2024, 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 the lens was observed to be scratched necessitating lens explantation and exchange.

• 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: 21100983
• Report Number: 3012304651-2025-00008
• Device Sequence Number: 15658057
• Product Code: HQL
• UDI-Device Identifier: 05029867692222
• UDI-Public: (01)05029867692222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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 Expiration Date: 06/26/2026
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 064245882
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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