MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problem Malposition of Device (2616)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the lens entered the eye in "s" orientation necessitating lens explantation.Lens explantation is reported to have been "uneventful".The product associated with this event was discarded by the healthcare facility.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".Rayone spheric rao100c and rayone aspheric rao600c are front/back symmetrical and therefore can be implanted in "s" orientation without any impact to visual acuity.Our review of production records for the rayone aspheric 600c batch 032187897 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from these batches were within tolerance, met specification criteria and were without defects.A reviw of existing vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone aspheric rao600c batch 032187897.

Event Description

On 5th july 2022, rayner intraocular lenses limited received notification from a uk healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states that the lens was implanted in "s" orientation leading to explantation of the iol.

• 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: 15064956
• MDR Text Key: 304721447
• Report Number: 3012304651-2022-00042
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691607
• UDI-Public: (01)05029867691607
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

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: 032187897
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2022
• 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