MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/06/2022
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 lens ruptured the capsular bag upon leaving the injector.The surgeon explanted the rayone aspheric rao600c iol, performed an anterior vitrectomy and implanted a three piece lens successfully without further incident during the original surgery session.The surgeon attributes capsule rupture to the lens coming out of the injector much faster than he anticipated.The rayone ifu "use of rayone" section "fig 7" states "press the plunger in a slow and controlled manner.If excessive resistance is felt this could indicate a blockage; stop and discard the injector and lens".The product subject to this report has not been returned to rayner.It is presumed to have been discarded following explant.Rayner's lifetime rate for "torn capsule during injection" for its rayone hydrophilic preloaded iol range is (b)(4).As demonstrated by our incident rate this is a rare failure mode and in no case received by rayner has a causal relation to the device been established.The rayner risk analysis identifies avdancing the plunger too quickly and forcing a jammed plunger during iol insertion as possible causes of capsule rupture.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 aspheric rao600c batch 081174588.Without the ability to examine the device and without clear event details being provided it is not possible to establish the cause of capsule rupture in this case.
Event or Problem Description
On 26th october 2022, rayner received notification from its us affiliate company of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that the lens ruptured the capsular bag upon leaving the injector.

• 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
• 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: 15757929
• Report Number: 3012304651-2022-00105
• Device Sequence Number: 6239074
• Product Code: HQL
• UDI-Device Identifier: 05029867692260
• UDI-Public: (01)05029867692260
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/09/2022

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: 08/04/2023
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 081174588
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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