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	Corneal Edema (1791)
Date of Event	12/20/2022
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 the lens got stuck in the injector and that on implantation into the eye the optic was damaged / cut in the middle.The lens was explanted during the original surgery session through an enlarged incision.Post-operatively, the patient is reported to have corneal oedema.The healthcare facility has advised that the product associated with this event.Is available.Rayner has requested the return of the device for evaluation.The rayone preloaded risk analysis identifies forcing a blocked injector and inadequate lubrication as possible causes of "lens optic damage".Additionally, the rayner hydrophilic acrylic intraocular lens 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 and cracked optic surface post injection due to dehydration of lens.Rayner is following up with its brazilian distributor to obtain additional information to facilitate further investigation of the event.The initial information received identifies that the lens did get stuck in the injector.The rayone ifu "use of rayone" section "fig 7" states ".If excessive resistance is felt this could indicate a blockage; discontinue use of the injector and iol".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 082198182.
Event or Problem Description
On (b)(6) 2023, rayner received notification from its brazilian distributor of an event that occurred during implantation of a rayone aspheric rao600c.The event description provided states that the iol got stuck in the injector and was implanted into the eye with a damaged optic necessitating explantation of the iol.

• 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: 16240363
• Report Number: 3012304651-2023-00010
• Device Sequence Number: 20409853
• Product Code: HQL
• UDI-Device Identifier: 05029867692291
• UDI-Public: (01)05029867692291
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 082198182
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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