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	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th september 2023, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone emv rao200e.The event description provided states that the lead haptic and optic were successfully inserted into the eye; however, the trailing haptic failed to deploy resulting in the healthcare professional cutting the trailing haptic off and explanting the lens.
Additional Manufacturer Narrative
The reference c23901 has been allocated to this case by rayner.The event description provided states that the lead haptic and optic were successfully inserted into the eye; however, the trailing haptic failed to deploy resulting in the healthcare professional cutting the trailing haptic off and explanting the lens.The additional information received identifies that the surgeon experienced resistance during injection.Within the "use of rayone" section of the ifu "fig 7" we include the statement "press the plunger in a slow and controlled manner.If resistance is felt this could indicate a blockage, stop and discard the injector and lens".A back-up lens was implanted successfully during the original surgery session.The healthcare facility has confirmed that there was no injury to the patient as a result of this event.Product return anticipated, not yet received by rayner.The results of the product evaluation performed will be provided in a follow-up report.Our review of production records for the rayone emv rao200e batch 052191521 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 emv rao200e batch 052191521.

• 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: 17833095
• Report Number: 3012304651-2023-00115
• Device Sequence Number: 6759648
• Product Code: HQL
• UDI-Device Identifier: 05029867006548
• UDI-Public: (01)05029867006548
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

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 Expiration Date: 05/15/2024
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 052191521
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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