MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(6) has been allocated to this case by rayner.The event description provided states that the plunger got stuck in injector and the iol broke.As a result of the event the patient was left aphakic.Due to unavailability of a back-up lens, the patient required a secondary implantation surgery.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.Our review of production records for the rayone emv rao200e batch 063217598 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 vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 063217598.It is not possible to establish root cause from the limited evidence and information available.
Event or Problem Description
On 6th february 2024, rayner received notification from its distirbutor in south africa of an event that occurred during use of a rayone emv rao200e.The event description provided states that the plunger got stuck in injector and the iol broke.As a result of the event the patient was left aphakic, due to unavailability of a back-up lens, requiring a secondary implantation surgery.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the plunger got stuck in injector and the iol broke.As a result of the event the patient was left aphakic.Due to unavailability of a back-up lens, the patient required a secondary implantation surgery.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.Our review of production records for the rayone emv rao200e batch 063217598 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 vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 063217598.The injector was returned dehydrated in the blister tray.Preliminary inspection of the returned injector showed that one of the movable flaps were closed and the plunger was fully retracted.Viscoelastic residue was also observed in the loading bay and in the nozzle.No lens was returned with the device.To facilitate further inspection of the returned product, the injector was disassembled.The injector parts were inspected under 10x magnification found now damage to any part of the device.To facilitate further testing of the injector, the injector was re-assembled.Used rayner stock rao 600c + 31.0 which was loaded and injected as per the ifu.Ophteisbio3.0% ovd was used.Injection was successful, with no resistance experienced, and with no damage to the lens or injector post injection.A toluidine blue 0.5% dye test was performed on the nozzle.This test did not identify any irregularity in the nozzle coating.From the testing performed we were not able to replicate the event as reported.Product testing performed confirms that the device performs as intended.No fault of the rayner injector was found.
Event or Problem Description
On 6th february 2024, rayner received notification from its distirbutor in south africa of an event that occurred during use of a rayone emv rao200e.The event description provided states that the plunger got stuck in injector and the iol broke.As a result of the event the patient was left aphakic, due to unavailability of a back-up lens, requiring a secondary implantation surgery.

• 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: 18756496
• Report Number: 3012304651-2024-00038
• Device Sequence Number: 14378555
• Product Code: HQL
• UDI-Device Identifier: 05029867006739
• UDI-Public: (01)05029867006739
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 11/12/2024

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 Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 063217598
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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