MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number RAO200E

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, rayner intraocular lenses limited received notification from its us sales team that a rayone emv rao200e +19.0d batch 012183745 system pack contained the inner blister tray (preloaded injector and iol) for the rayone emv rao200e +21.0 d batch 012183845.The product as subject to this report was not used; however, it was identified within the initial notification that prior implantation of a lens from the same batch had occurred.Investigation by rayner identified that the issue affected all units in the rayone emv rao200e +19.0d batch 012183745 and rayone emv rao200e +21.0 d batch 012183845.The acute consequence of the health hazard to the patient is a refractive surprise; a deviation in target refraction that could be noticed by the patient following surgery (manifesting in this case as blurred distance vision due to the myopic refractive error) which would be confirmed when the patient's surgical/optical team determines the patient's refraction.The most probable result for patients who have undergone implantation of a +21.0 d emv lens as opposed to the required +19.0 d is a 2.0 d myopic outcome.The rayone emv rao200e +19.0d batch 012183745 is subject to a voluntary recall.The rayone emv rao200e +21.0 d batch 012183845 remains under rayner's direct control (no units have been shipped to end-users at any time).All recall paperwork has been supplied to oradevices2recalls@fda.Hhs.Gov and is being processed by (b)(6), recall coordinator.The reference assigned to the recall action is 3012304651-05/17/2022-001-r.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The discrepancy between the labelled power of +19.0 d on the outer carton pack and the inner blister tray labelled power of +21.0 d was noted by the healthcare facility prior to use and the product was not used.The unused unit has been shipped back to metro park, rayner's us importer as per rayner instruction.A voluntary recall was initiated by rayner following receipt of this initial event report (as described this report).All recall paperwork has been supplied to oradevices2recalls@fda.Hhs.Gov and is being processed by marie fink, recall coordinator.The reference assigned to the recall action by fda is 3012304651-05/17/2022-001-r.

• Brand Name: RAYONE EMV
• Type of Device: RAYONE EMV
• 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: 14461037
• MDR Text Key: 300326665
• Report Number: 3012304651-2022-00024
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: (01)05029867006685
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 17
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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