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 08/11/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that the surgeon observed an imperfection on the optic immediately post implantation and explanted the lens.

Manufacturer Narrative

The reference (b)(6) has been allocated to this case by rayner.The event description provided states that the surgeon observed an imperfection on the lens immediately post implantation necessitating explantation of the iol.The device was discarded by the healthcare facility immediately after explantation.Rayner performs comprehensive testing throughout its manufacturing process and in addition to the multi-stage 100% inspection rayner perform, one sample product from every batch is removed for qa batch control testing.This includes injection testing whereby injection performance, lens orientation, and the condition of the injector and lens post-injection is evaluated prior to the batch being released for distribution.Our records confirm that all checks were performed successfully without incident for the rayone aspheric rao600c batch 032188376.In the absence of any evidence or the product being returned, it is not possible to establish the origin or cause of the reported "imperfection" observed on the iol.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone aspheric rao600c batch 032188376.

• 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: 15281635
• MDR Text Key: 305501960
• Report Number: 3012304651-2022-00053
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867692284
• UDI-Public: (01)05029867692284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: :P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: 032188376
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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 Age: 70 YR
• Patient Sex: Male