MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 only half of the iol was delivered into the eye.The second half of the lens was trapped in the injector nozzle.The lens was explanted and exchanged for another iol in the original surgery session.The healthcare facility has confirmed that there is no harm/injury to the patient as a result of the event.Possible causes include but are not limited to: 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, user removes 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.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, user removes 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 product was not available for return in this case, it is presumed to have been discarded by the healthcare facility.Without the ability to examine the device associated with the event it is not possible to establish the root cause of the lens failing to fully deliver.
Event or Problem Description
On 22nd april 2021, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that only half of the lens came out of the injector necessitating lens removal and exchange.

• 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
• MDR Report Key: 11775471
• Report Number: 3012304651-2021-00016
• Device Sequence Number: 3721751
• Product Code: HQL
• UDI-Device Identifier: 05029867692314
• UDI-Public: (01)05029867692314
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 10/19/2022
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 100160462
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1