MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided by the distributor states that the haptic broke and the capsule ruptured during implantation resulting in the lens falling into the vitreous.The surgical procedure was extended and a retinal specialist performed a vitrectomy.The fact that the lens was delivered with a broken haptic may suggest that the lens became trapped during injection and that continued depression of the plunger has caused faster expulsion of the iol from the injector resulting in pc rupture.The product is not available for return in this case.It was discarded following use/explant.(b)(4).Rayner is continuing to follow-up with its sales agent to obtain additional information (including patient medical history, as there are certain conditions that may make a patient more pre-disposed to pc rupture) to facilitate further investigation of this event.This is an isolated report.A review of existing vigilance data confirms that no other incidents, of any type, have been received against the rayone emv rao200e batch 031164682.Our review of production records for the rayone emv rao200e batch 031164682 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.
Event or Problem Description
On (b)(6) 2021, rayner intraocular lenses limited received notification from its us affiliate company of an event that occurred during use of a rayone emv rao200e.The event description provided states that the haptic broke during implantation and that the capsular bag ruptured resulting in the lens falling through the vitreous.

• 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
• MDR Report Key: 12016535
• Report Number: 3012304651-2021-00024
• Device Sequence Number: 3259870
• Product Code: HQL
• UDI-Device Identifier: 05029867006753
• UDI-Public: (01)05029867006753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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: 03/03/2023
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 031164679
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention