MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number	RAO100C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
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 the capsular bag ruptured during iol implantation.The rayner rayone preloaded injector risk analysis identifies the following as possible causes of "explosive expulsion of lens" resulting in capsule rupture; plunger advanced too quickly and forcing jammed plunger during iol insertion.Lens delivered in 's' orientation is also identified as a possible cause of capsule rupture within the risk analysis.Our review of production records for the rayone spheric rao100c batch 083222361 showed that all manufacturing and quality checks were conducted with successful results.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone spheric rao100c batch 083222361.There is insufficient evidence and information available to establish the cause of capsule rupture during iol implantation.
Event or Problem Description
On 9th october 2024, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone spheric rao100c.The event description provided states that the capsular bag ruptured during iol implantation.

• Brand Name: RAYONE SPHERIC
• Common Device Name: RAYONE SPHERIC
• 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: 20522034
• Report Number: 3012304651-2024-00285
• Device Sequence Number: 13033575
• Product Code: HQL
• UDI-Device Identifier: 05029867689550
• UDI-Public: 05029867689550
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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 Expiration Date: 08/17/2025
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 083222361
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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