MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that immediately following implantation the healthcare professional observed a foreign object or scratch on the lens which led them to explant and exchange the rayone emv rao200e iol.The product has been retained and is being returned to rayner; however, to date, no product has been received by rayner for inspection.The rayner hydrophilic iol use fmea identifies the following as possible causes of "physical damage to lens"; sharp edge instruments used during surgical procedure, surgical procedure: incorrect use of lens injection system, surgeon misidentifying capsule creasing, lens surface ablated by nd:yag operator error (not applicable in this case) and cracked optic surface post injection due to dehydration of lens.Rayner is following up with its german affiliate company to obtain additional information to facilitate further investigation of the event.There is currently insufficient evidence and information available to establish the cause of the event.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 100161020.
Event or Problem Description
On (b)(6) 2023, rayner received notification from its german affiliate company of an event that occurred during use of a rayone emv rao200e.The event description provided states that a foreign object and/or scratch was observed on the lens immediately following implantation necessitating explantation of the iol.

• 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: 16851894
• Report Number: 3012304651-2023-00061
• Device Sequence Number: 7566563
• Product Code: HQL
• UDI-Device Identifier: 05029867006760
• UDI-Public: (01)05029867006760
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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: 10/24/2025
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 100161020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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