MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problem Optical Problem (3001)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Event Description

On (b)(6) 2023, rayner received notification via its affiliate company in the us of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that post-operatively the patient's spherical visual outcome was not as expected post-operatively.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively the patient's spherical visual outcome was not as expected post-operatively.The target refractive outcome was -0.4 but the result is -4.0 just shy of one month post-operatively.The patient medical history received identified that the patient had previously twice undergone hyperopic lasik in the subject eye.Lens explantation and exchange is planned.No device has been received by rayner for evaluation.Surgical outcomes can be influenced by many factors including but not limited to; incorrect product selection, aniseikonia combined with unsuitable lens power selection and wrong lens power caused by incorrect biometry readings/calculations, toric axis misalignment, posterior synechiae, irregular capsular bag contraction, residual ovd in capsular bag (cbds), lens does not fit anatomy of eye, prior lasik surgery, incorrect cylinder power selection by surgeon and surgically induced corneal changes."deviation in target refraction" is listed in the "adverse events" section of the rayone ifu.Despite efforts made by rayner to obtain additional information to facilitate further investigation, no ufrther information has been forthcoming.While it is not due to establish the root cause of the deviation in target refraction from the limited information available, it is possible that the patient's prior lasik surgery has impacted the final refractive outcome in this case.

• 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: 17497100
• MDR Text Key: 320766057
• Report Number: 3012304651-2023-00099
• Device Sequence Number: 1
• Product Code: HQL
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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