MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, 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 lens was observed to have two cracks on the optic.
Additional Manufacturer Narrative
The reference (b)(6) has been allocated to this case by rayner.The event description provided states that immediately following implantation the lens was observed to have two cracks on the optic necessitating explantation.The rayone aspheric rao600c was explanted and exchanged during the original surgery session."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.Product return anticipated, not yet received.The rayner rayone preloaded injection system use risk analysis identifies the following as possible causes of damage to lens; forcing a blocked injector, inadequate lubrication, misuse of device and optic edge trapped/damaged on closure of cartridge.There is insufficient evidence and information available currently to determine the cause of the damage to the lens post injection.Our review of production records for the rayone aspheric rao600c batch 083222544 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 existing vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone aspheric rao600c batch 083222544.

• 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: 18517127
• Report Number: 3012304651-2024-00004
• Device Sequence Number: 12450407
• Product Code: HQL
• UDI-Device Identifier: 05029867692222
• UDI-Public: (01)05029867692222
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 08/22/2025
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 083222544
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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