MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TORIC

Model Number RAO210T

Device Problem Optical Decentration (1360)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, rayner received notification from a healthcare facility in new zealand of an event that occurred following implantation of a rayone toric rao610t.The event description provided states that the "patient ended up with a haptic in the sulcus" which necessitated in an additional surgery to reposition the lens to achieve correct iol fixation within the capsular bag.

Manufacturer Narrative

The reference c240546 has been allocated to this case by rayner.The patient underwent implantation of a rayone toric rao610t on (b)(6) 2023.At examination on (b)(6) 2024, it was observed that one of the iol haptics had entered the sulcus.The patient had a secondary procedure performed to reposition the iol within the capsular bag.Decentration, tilt and rotation are known complications associated with cataract surgery and iol fixation.While it is not possible to establish the definitive root cause in this case it is possible to consider the following as potential contributory factors which may have resulted in the reported event; incorrect/unstable iol fixation within the capsular bag at time of iol implantation, irregular capsular bag contraction, residual ovd in capsular bag (cbds) and lens not fitting the anatomy of the eye.Our review of production records for the rayone toric rao610t batch 072196790 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 against the rayone toric rao610t batch 072196790.There is no evidence of a device-related cause for the post-operative change in iol fixation within the eye.

• Brand Name: RAYONE TORIC
• Type of Device: RAYONE TORIC
• 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: 18957510
• MDR Text Key: 339329004
• Report Number: 3012304651-2024-00065
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867461293
• UDI-Public: (01)05029867461293
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 072196790
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2022
• 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