MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number RAO200E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 visual outcome of the patient post-operatively was not as expected.The patient underwent an additional surgical procedure to have the rayone emv rao200e explanted and exchanged."deviation from target refraction" and "iol replacement or extraction" are listed in the "adverse events" section of the rayone ifu.There are many factors which may influence the post-operative outcome of the patient including but not limited to; incomplete removal of ovd following iol implantation (capsular block/capsular bag distension syndrome), dry eye during biometry measurement, incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), incorrect power selection (not using optimised a-constants may be a contributory factor in this scenario - surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.), posterior synechiae, irregular capsular bag contraction, patient medical history (e.G., glaucoma, pseudoexfoliation syndrome), lens decentration or dislocation, incorrect or unstable fixation within the capsular bag, post-operative rotation of the lens, lens does not fit anatomy of the eye (e.G., too large or too small), capsulorhexis diameter too large and induced surgical astigmatism.There is insufficient information to establish the cause of the deviation in target refraction in this case.Rayner is following up via its in-country representatives to obtain additional information.The return of the explanted iol is also being sought for evaluation.

Event Description

On 1st april 2024, rayner received notification from its us healthcare facility of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that the healthcare professional explanted the rayone emv rao200e post-operatively as 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: 19123439
• MDR Text Key: 341260692
• Report Number: 3012304651-2024-00091
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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