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	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 15th february 2023, rayner received notification from a uk healthcare facility of an event that occurred during implantation of a rayone aspheric rao600c.The event description provided states that immediately following implantation into the eye the iol optic was observed to be broken necessitating lens explantation.
Additional Manufacturer Narrative
The reference (b)(6) has been allocated to this case by rayner.The verbatim report received states that immediately following implantation into the eye the optic was observed to be cut/broken.The rayone aspheric rao600c was explanted and exchanged during the original surgery session without any injury to the patient.The device was discarded by the healthcare facility following explantation."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The rayone preloaded iol injection system use risk analysis identifies forcing a blocked injector and inadequate lubrication as possible causes of "lens optic damage".Additionally, the rayner hydrophilic acrylic intraocular lens use risk analysis identifies the following as possible causes of "physical damage to iol"; sharp edge instruments used during surgical procedure, surgical procedure incorrect, incorrect use of lens injection system, surgeon misidentifying posterior capsule creasing, lens surface ablated by nd:yag operator error (not applicable in this case) and cracked optic surface post injection due to dehydration of lens.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 072196797.Without the ability to examine the device and without clear event details being provided it is not possible to determine the root cause of the damage to the optic immediately following implantation.

• 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: 16407542
• Report Number: 3012304651-2023-00016
• Device Sequence Number: 12236842
• Product Code: HQL
• UDI-Device Identifier: 05029867692284
• UDI-Public: (01)05029867692284
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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: 072196797
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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