MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE TRIFOCAL

Model Number RAO603F

Device Problems Optical Decentration (1360); Material Split, Cut or Torn (4008)

Patient Problem Visual Disturbances (2140)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the immediately following implantation into the eye the lens was cut and that it was off-centre.The lens was left in situ; however, the healthcare facility has scheduled an additional surgical procedure to explant and exchange the rao603f iol.The information received at this stage does not identify which part of the iol was cut.The verbatim report of the lens being off-centre is suggestive of damage to the haptic which could impact stability/centration within the capsular bag.Rayner has requested additional information via its distributor in (b)(4) to facilitate further investigation of the event.The device has not been made available to rayner for evaluation.The rayner risk analysis identifies the following as possible causes of "trapped/torn lens haptic/optic during insertion"; inadequate amount of viscoelastic, inadequate quality of viscoelastic, haptic trapped by plunger override due to fast motion, user opens closed flaps and closes again before use, plunger advanced too quickly, insertion of viscoelastic through nozzle leading to inadequate amount of viscoelastic, user removed injector from tray prior to inserting viscoelastic - causing lens to be improperly placed in cartridge, user removes injector from tray prior to closing cartridge - resulting in cartridge not being clipped closed properly and optic edge trapped/damaged on closure of cartridge.Our review of production records for the rayone trifocal rao603f batch 111180705 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 without defects.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 rao603f batch 111180705.

Event Description

On 23rd march 2022, rayner intraocular lenses limited received notification from its brazilian distributor of an event that occurred during use of a rayone trifocal rao603f.The event description provided states that immediately following implantation the lens was observed to be cut and off-centre.An additional surgical procedure has been scheduled by the healthcare facility to explant and exchange the lens.

• Brand Name: RAYONE TRIFOCAL
• Type of Device: RAYONE TRIFOCAL
• 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: 13976746
• MDR Text Key: 290553579
• Report Number: 3012304651-2022-00012
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867143458
• UDI-Public: (01)05029867143458
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/01/2022

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO603F
• Device Catalogue Number: RAO603F
• Device Lot Number: 111180705
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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
• Patient Outcome(s): Required Intervention