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	Insufficient Information (4580)
Date of Event	05/15/2023
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 left the injector too fast resulting in the capsular bag breaking.The rayone emv rao200e iol was explanted during the original surgery session.Product return is anticipated; however, no product has been received by rayner to date for evaluation.The rayner risk analysis identifies advancing the plunger too quickly and forcing a jammed plunger during iol insertion as possible causes of capsule rupture."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.Rayner is following up via its affiliate company in france to obtain additional information to facilitate further investigation of the event.The national ophthalmology database audit report for 2022 states that for all surgeons 0.91% of operations were affected by posterior capsule rupture (pcr) and that this is slightly below the currently consultant only rate of 1.1%.Our lifetime rate of posterior capsule rupture for our rayone hydrophilic platform is 0.0012% / 12 ppm, which is well below the rates published in the nod audit report.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 072195901.
Event or Problem Description
On (b)(6) 2023, rayner received notification from its french affiliate company of an event that occurred during use of a rayone emv rao200e.The event description provided states that the lens left the injector too fast breaking the capsular bag.

• 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: 17018882
• Report Number: 3012304651-2023-00069
• Device Sequence Number: 6343294
• Product Code: HQL
• UDI-Device Identifier: 05029867006739
• UDI-Public: (01)05029867006739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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: 072195901
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown