MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number RAO200E

Device Problem Optical Problem (3001)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Event Description

On (b)(6) 2022, rayner received notification from its brazilian distributor of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that the patient's post-operative outcome was not as expected.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient's refractive outcome post-operatively was not as expected.The patient's refractive outcome is reported as -150 20/25.The device is not available for return.The iol remains implanted.There are many factors that may influence a post-operative refractive outcome including but not limited to incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), surgically induced astigmatism, patient pre-existing medical history limiting ability for visual correction, patient not tolerating functional style of the lens, and lens rotation, decentration or tilt.Rayner is following up with its distributor to obtain additional information to facilitate further investigation of the event."deviation from target refraction" is listed in the "adverse events" section of the rayone ifu.

• 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: 15707520
• MDR Text Key: 307268275
• Report Number: 3012304651-2022-00097
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867006234
• UDI-Public: (01)05029867006234
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 032187408
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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: 62 YR
• Patient Sex: Male