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

Model Number RAO210T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that three weeks after surgery, pco was observed along with vacuoles on the anterior surface of the lens.The patient has had a cdva of 0.5 since the initial post-operative examination.An additional surgery to explant and exchange the lens was performed on (b)(6) 2024.The return of the explanted lens has been requested.Posterior capsule opacification (pco) typically presents in the region of 2-5 years post-operatively, therefore the onset of reported pco 3 weeks post-operatively is quite unsual and perhaps more indicative of some sort of intraocular response post surgery such as fibrin reaction or capsular bag distension syndrome causing the lens to appear cloudy.Our review of production records for the rayone emv toric rao210t batch 093225244 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 emv toric rao210t batch 093225244.There is currently insufficient evidence and information available to establish the cause of the event.Additional information is being sought from the reporter to facilitate further investigation.

Event Description

On 5th april 2024, rayner received notification from its distirbutor in denmark of an event that occurred following implantation of a rayone emv toric rao210t.The event description provided states that three weeks after surgery pco was observed along with vacuoles on the anterior surface of the lens.

• Brand Name: RAYONE EMV TORIC
• Type of Device: RAYONE EMV 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: 19133651
• MDR Text Key: 341037341
• Report Number: 3012304651-2024-00095
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 04/18/2024

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: RAO210T
• Device Catalogue Number: RAO210T
• Device Lot Number: 093225244
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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