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 patient presented post-operatively with a -1.5 d myopic refractive suprise.The healthcare professional plans to explant and exchange the rayone emv rao200e iol.Rayner has requested the return of the lens following explant 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, decentration, tilt or rotation of the iol and surgically induced corneal changes."deviation in target refraction" is listed in the "adverse events" section of the rayone ifu.There is insufficient evidence and information available to determine the root cause of the deviation in target refractive outcome.Rayner is seeking additional information from the healthcare facility to obtain additional information to facilitate further investigation of this event.

Event Description

On 14th october 2023, rayner received notification from its singapore distributor of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that post-operatively the patient has presented with a refractive error of -1.5 d.

• 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: 17948288
• MDR Text Key: 325934685
• Report Number: 3012304651-2023-00139
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: NOT AVAILABLE
• Date Manufacturer Received: 10/14/2023
• 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