MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number RAO200E

Device Problem Ejection Problem (4009)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(6) has been allocated to this case by rayner.The verbatim report received states "sudden burst of built-up pressure in the nozzle, iol shoot off abruptly into the bag, causing capsule rupture".The lens was explanted and exchanged during the initial surgery session.A 3 piece iol was implanted successfully without further incident.The product is not available for return.The device was discarded by the healthcare facility.The additional information received identifies that the user experienced slightly more resistance than normal during injection.The rayone ifu "use of rayone" section "fig 7" states ".If excessive resistance is felt this could indicate a blockage; stop and discard the injector and lens".The rayner risk analysis identifies the following as possible causes of "explosive expulsion of lens"; plunger advanced too quickly and forcing jammed plunger during iol insertion.Our review of production records for the rayone emv rao200e batch 062193939 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from these batches were within tolerance, met specification criteria and were without defects.A review of existing vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 062193939.

Event Description

On (b)(6) 2022, rayner received notification from its malaysia distributor of an event that occurred during use of a rayone emv rao200e.The verbatim report received states "sudden burst of built-up pressure in the nozzle, iol shoot off abruptly into the bag, causing capsule rupture".

• Brand Name: RAYONE EMV
• Type of Device: 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: 15549526
• MDR Text Key: 306500797
• Report Number: 3012304651-2022-00063
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867006197
• UDI-Public: (01)05029867006197
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 062193939
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1