MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TORIC

Model Number RAO610T

Device Problem Positioning Problem (3009)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of the rayone toric rao610t iol on (b)(6) 2021.On an unknown date in (b)(6) 2022, decentration of the iol was observed for the first time.Decentration is reported to have resulted in a reduction to the patient's visual acuity.An additional surgical procedure to reposition the lens was scheduled for (b)(6) 2022.Trauma, prior vitreoretinal surgery, pseudoexfoliation syndrome, lens not fitting anatomy of the eye, long axial lengths residual ovd behind lens (capsular block) certain connective tissue disorders and inflammation in the eye are risk factors of iol subluxation/decentration identified within published literature.Rayner is continuing to liaise with the reporter to obtain additional information to facilitate further investigation of the event.Information on lens stability post repositioning has also been requested.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 toric rao610t batch 081175417.

Event Description

On 25th march 2022, rayner intraocular lenses limited received notification from its danish distributor of an event that occurred following implantation of a rayone toric rao610t.The event description provided states that lens has decentered resulting in a reduction in the patient's visual acuity.

• 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: 13977225
• MDR Text Key: 298235947
• Report Number: 3012304561-2022-00013
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867460678
• UDI-Public: (01)05029867460678
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO610T
• Device Catalogue Number: RAO610T
• Device Lot Number: 081175417
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention