MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 23rd april 2024, rayner received notification from its distributor in the united arab emirates of an event that occurred during use of a rayone emv rao200e.The event description provided states that during iol implantation, the posterior capsule ruptured.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that during iol implantation the posterior capsule ruptured.The rayone emv rao200e was explanted during the original surgery session and exchanged for another iol.The cornea was sutured and a 3 piece sulcus iol was also implanted."iol extraction or replacement" is listed in the "adverse events" section of the rayone ifu.The device has been discarded by the healthcare facility.The rayner rayone preloaded iol injection system risk analysis identifies advancing the plunger too quickly and forcing a jammed plunger during iol insertion as possible causes of capsule rupture.Our review of production records for the rayone emv rao200e batch 013207122 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 013207122.The cause of capsule rupture cannot be established from the limited information available.

• 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: 19358422
• Report Number: 3012304651-2024-00101
• Device Sequence Number: 20424981
• Product Code: HQL
• UDI-Device Identifier: 05029867006791
• UDI-Public: (01)05029867006791
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 013207122
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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 Age: 56 YR
• Patient Sex: Male