MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problem Material Integrity Problem (2978)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

On 14th december 2022, rayner received notification from its affiliate company in germany of an event that occurred during use of rayone aspheric rao600c.The event description provided states that the lens waas damaged during implantation and was therefore explanted immediately from the eye.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states "lens outside the optic damaged during implantation of the lens the defect was noticed lens explanted new inserted".The procedure was completed during the original surgery session with a back-up iol.There was no injury to the patient because of the event.Product return is expected but not yet received.The results of the product inspection performed will be provided in a follow-up report.Rayner is liasing with the reporter to obtain additional information to facilitate further investigation of the event.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 aspheric rao600c batch 072196834.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states "lens outside the optic damaged during implantation of the lens the defect was noticed lens explanted new inserted".The procedure was completed during the original surgery session with a back-up iol.There was no injury to the patient because of the event.Product inspection was carried out on (b)(6) 2023.The injector was returned dehydrated in a plastic bag.The iol was returned hydrated in a plastic vial.Cosmetic inspection of the iol was performed under 10x magnification.Inspection identified part of the optic and haptic on one side of the lens, which might suggest that the lens got trapped in the cartridge at the point the flaps were closed.Inspection of the injector identified that the flaps were closed, and the plunger was retracted.No damage to the nozzle was observed.The injector was dis-assembled, and the plunger soft-tip was found to be torn.The broken fragments of the lens could not be found within the injector.No testing of the returned lens was possible due to the damaged nature of the device.The injector was re-assembled with a new plunger and 1x rayone aspheric rao600c +24.0 d was loaded and injected as per the ifu.Injection was successful with no damage to the lens or injector post-injection.A dye test performed confirmed that the nozzle was regularly coated and there was no evidence of delamination.Product inspection confirms the event as reported; however, has been unable to determine the root cause of the event.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 aspheric rao600c batch 072196834.

Event Description

On 14th december 2022, rayner received notification from its affiliate company in germany of an event that occurred during use of rayone aspheric rao600c.The event description provided states that the lens waas damaged during implantation and was therefore explanted immediately from the eye.

• Brand Name: RAYONE ASPHERIC
• Type of Device: RAYONE ASPHERIC
• 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: 15986294
• MDR Text Key: 305498652
• Report Number: 3012304651-2022-00122
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691591
• UDI-Public: (01)05029867691591
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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 Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 072196834
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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