MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TRIFOCAL

Model Number RAO603F

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Visual Disturbances (2140); Eye Pain (4467)

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4).Has been allocated to this case by rayner.The event description provided states that immediately following implantation, it was observed that the iol optic and haptic were broken.The rayone trifocal rao603f iol was explanted and exchanged during the original surgery session."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.Post-operatively, the patient is reported to be experiencing eye pain, visual disturbances, increased intraocular pressure and edema.These are likely artefacts of the explant process in this case.The rayone preloaded iol injection system use risk analysis identifies the following as possible causes of "trapped/torn lens haptic/optic during insertion"; inadequate amount of viscoelastic, inadequate quality of viscoelastic, haptic trapped by plunger override due to fast motion, user opens closed flaps and closes again before use, plunger advanced too quickly, insertion of viscoelastic through nozzle leading to inadequate amount of viscoelastic, user removed injector from tray prior to inserting viscoelastic - causing lens to be improperly placed in cartridge, user removes injector from tray prior to closing cartridge - resulting in cartridge not being clipped closed properly and optic edge trapped/damaged on closure of cartridge.Our review of production records for the rayone trifocal rao603f batch 073220080 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.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received agianst the rayone trifocal rao603f batch 073220080.There is insufficient evidence and information available in this case to determine the cause of lens damage post injection.

Event Description

On (b)(6) 2024, rayner received notification of an event from its distirbutor in the philippines that occurred during use of a rayone trifocal rao603f.The event description provided states that the iol was found to be defective immediately following implantation, with the iol optic and haptic both broken, necessitating explantation and exchange.

• Brand Name: RAYONE TRIFOCAL
• Type of Device: RAYONE TRIFOCAL
• 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: 18959975
• MDR Text Key: 338774683
• Report Number: 3012304651-2024-00067
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867143373
• UDI-Public: (01)05029867143373
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO603F
• Device Catalogue Number: RAO603F
• Device Lot Number: 073220080
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2023
• 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