MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 19th may 2023, rayner received notification from its brazilian distributor of an event that occurred during use of a rayone emv rao200e.The event description provided states that the haptic broke during implantation necessitating explantation through an enlarged incision.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the haptic broke during iol implantation.The rayone emv rao200e iol was explanted through an enlarged incision.The healthcare facility reports that as a result of the need to enlarge the incision there was an increase in corneal astigmatism post-operatively.However, has confirmed that there was no impact to the final visual acuity.The healthcare facility has confirmed that there was no injury/impact to the patient as a result of the event.The rayone preloaded iol injection system use risk analysis identifies the following as possible causes of "trapped/torn lens haptic/optic during insertion"; inadequate amount of viscoelastic, inadequate quality of viscoelastic, haptic trapped by plunger override due to fast motion, user opens closed flaps and closes again before use, plunger advanced too quickly, insertion of viscoelastic through nozzle leading to inadequate amount of viscoelastic, user removed injector from tray prior to inserting viscoelastic - causing lens to be improperly placed in cartridge, user removes injector from tray prior to closing cartridge - resulting in cartridge not being clipped closed properly and optic edge trapped/damaged on closure of cartridge.The device has been confirmed as being available for return; however, to date, no product has been received by rayner for evaluation.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 emv rao200e batch 112202177.

• Brand Name: RAYONE EMV
• Common Device Name: RAYONE EMV
• 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: 17018418
• Report Number: 3012304651-2023-00068
• Device Sequence Number: 6343713
• Product Code: HQL
• UDI-Device Identifier: 05029867006746
• UDI-Public: (01)05029867006746
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 112202177
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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