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  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the refractive outcome of a patient following implantation of a rayone emv rao200e was not as expected.The patient's uvca is 20/30 and bcva 20/20.The device is not available to rayner for evaluation.To rayner's knowledge, 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 has made multiple follow-up attempts to obtain additional information to facilitate further investigation; however, all attempts have been without success.Without clear event details being provided it is not possible to establish the cause of the refractive outcome in this case."deviation in target refraction" is listed in the "adverse events" section of the rayone ifu.

Event Description

On 28th september 2022, rayner received notification from its distributor in the united arab emirates of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that post-operatively the patient's visual 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 post-operatively the patient's refractive outcome wasn't as expected.The product was 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."deviation from target refraction" is listed in the "adverse events" section of the rayone ifu.The follow up information received from the distributor identifies that the differentiation in predicted and actual post-operative outcomes was likely due to the surgeon not taking into consideration the pre-op aberration of the eye prior to selecting the lens for implantation.Rayner has now been advised that the patient is satisfied with their visual outcome.

Event Description

On 28th september 2022, rayner received notification from its distributor in the united arab emirates of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that post-operatively the patient's visual outcome was not as expected.

• 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: 15649973
• MDR Text Key: 307040700
• Report Number: 3012304651-2022-00091
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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: NOT AVAILABLE
• Date Manufacturer Received: 09/28/2022
• 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