MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TRIFOCAL TORIC

Model Number RAO613Z

Device Problem Malposition of Device (2616)

Patient Problem Eye Injury (1845)

Event Type  malfunction  

Event Description

On 25th january 2023, rayner received notification from a uk healthcare facility of an event that occurred during implantation of a rayone trifocal toric rao613z.The event description provided states that the iol flipped during ejection.The surgeon struggled to correct the orientation of the lens in the eye and therefore had to explant the lens.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that the iol flipped during ejection.The surgeon struggled to correct the orientation of the lens in the eye and therefore had to explant it.As a consequence the capsular bag was slightly damaged and stability didn't improve despite the intension of a capsular tension ring (ctr).The surgeon had to perform a vitrectomy and implant a back-up lens.The patient is reported to recovering very slowly as a consequence.Product tests from every batch show us that lenses are very rarely loaded upside down.User behaviour can influence the orientation of the lens e.G., removing the injector from the blister tray prior to insertion of ovd/flap closure (deviation from the ifu) can change the position of the lens within the cartridge.Too little, or no ovd can lead to misalignment of the lens and in a very small number of cases (estimated to be less than 2%), a failed or damaged injection.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of the event.The product has been retained and is expected to be returned to rayner; however, has not yet been received."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.There is insufficient information available currently to determine the cause of the incorrect iol orientation.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 trifocal toric rao613z batch 072194852.

• Brand Name: RAYONE TRIFOCAL TORIC
• Type of Device: RAYONE TRIFOCAL 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: 16310283
• MDR Text Key: 308931884
• Report Number: 3012304651-2023-00013
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867145681
• UDI-Public: (01)05029867145681
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

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
• Device Operator: Health Professional
• Device Model Number: RAO613Z
• Device Catalogue Number: RAO613Z
• Device Lot Number: 072194852
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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
• Patient Outcome(s): Required Intervention