MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TORIC

Model Number RAO610T

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to the case by rayner.The event description provided states that the iol implant misfired and that the haptic had turned the wrong way round necessitating lens revision and replacement and resulting in an extension to surgery.A back-up lens was implanted during the initial surgery session without further incident and without any injury to the patient.Surgery is reported as being prolonged due to the event.The product associated with this event has been retained by the healthcare facility.Rayner has requested the return of the device for inspection.There is currently insufficient information available to determine the cause of the event.Additional information has been requested in addition to the return of the device to facilitate further investigation of this case.Our review of production records for the rayone toric rao610t batch 089141216 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 existing vigilance data from the month of manufacture of the rayone toric rao610t (august 2019) was carried out to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the rayone toric rao610t batch 089141216.

Event Description

On 9th september 2021, rayner intraocular lenses limited received notification from a uk healthcare facility of an event that occurred during use of a rayone toric rao610t.The event description provided states that the iol implant misfired and that the haptic had turned the wrong way round necessitating lens revision and replacement and resulting in an extension to surgery.

Event Description

On 9th september 2021, rayner intraocular lenses limited received notification from a uk healthcare facility of an event that occurred during use of a rayone toric rao610t.The event description provided states that the iol implant misfired and that the haptic had turned the wrong way round necessitating lens revision and replacement and resulting in an extension to surgery.

Manufacturer Narrative

The reference (b)(4) has been allocated to the case by rayner.The event description provided states that the iol implant misfired and that the haptic had turned the wrong way round necessitating lens revision and replacement and resulting in an extension to surgery.A back-up lens was implanted during the initial surgery session without further incident and without any injury to the patient.Surgery is reported as being prolonged due to the event.The product associated with this event has been retained by the healthcare facility.Preliminary inspection of the device showed that the movable flaps were closed, the plunger was fully retracted, and the lens was stuck in the bottom part of the nozzle.Plenty of viscoelastic residue was also observed.To facilitate further inspection and testing of the device, the injector was disassembled, and the lens was removed from the nozzle.Product testing has been unable to replicate the event as reported and confirms that the device performs as intended.No device fault found.Our review of production records for the rayone toric rao610t batch 089141216 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 existing vigilance data from the month of manufacture of the rayone toric rao610t ((b)(6) 2019) was carried out to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the rayone toric rao610t batch 089141216.

• 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
• MDR Report Key: 12512211
• MDR Text Key: 272669176
• Report Number: 3012304651-2021-00037
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: RAO610T
• Device Catalogue Number: RAO610T
• Device Lot Number: 089141216
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1