MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problems Malposition of Device (2616); Material Integrity Problem (2978)

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

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

The reference c23172 has been allocated to this case by rayner.The event description provided states that the lens was turned 180° and had 2 small protrusions peripherally.The iol remains implanted.Product tests from every batch show us that the lenses are very rarely loaded upside down.Rao100c and rao600c are front/back symmetrical, they can be implanted in "s" configuration with no impact to visual acuity.User behaviour can influence the orientation of the lens e.G., removing the injector from the blister tray prior to insertion of ovd/flap closure (deviation from the ifu) can change the position of the lens within the cartridge.Too little, or no ovd can lead to misalignment of the lens and in a very small number of cases (estimated to be less than 2%), a failed or damaged injection.It should also be noted that injecting ovd into any other part of the rayone injector (e.G., including directly into the nozzle tip) is not described in the ifu and could cause the iol to become misaligned and/or lead directly to injection issues.Using the correct amount of ovd (equivalent to approximately 0.3ml) ensures that enough force is generated to mechanically move the iol down into the bottom of the chamber ready for folding.The rayone ifu "use of rayone" section "fig 7" includes the following statement ".In the case of iol rotation during ejection from the nozzle, gently rotate the injector in the opposite direction to counteract any movement".Rayner is following up with its german affiliate company to obtain additional information to facilitate further investigation of the event.

Event Description

On (b)(6) 2023, rayner received notification from a german healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that the lens was turned 180° and had 2 small protrusions peripherally.

• 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 Contact: the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 -8AQ
• MDR Report Key: 16500907
• MDR Text Key: 310858216
• Report Number: 3012330465-2023-00029
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691638
• UDI-Public: (01)05029867691638
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2023

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: 092201050
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2022
• 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