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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, rayner received notification from a uk healthcare facility 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 anterior capsule phimosis.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively the patient has presented with anterior capsule phimosis.The general consensus within published literature is that capsule phimosis was usually a result of a small capsulorhexis.In the rayone ifu it states that the rhexis size should be carefully controlled.As there is also a risk of lens decentration if the rhexis is too large, we advise 0.5mm overlay between the lens edge and the rhexis all round.The reporting healthcare professional has advised that as he is aware of the issue of capsule phimosis and as a result he makes the capsulorhexis bigger.The root cause of capsule phimosis in this case cannot be established from the limited information available; however, there is no evidence or information to suggest a causal relation to the implanted rao200e.

• 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: 18996856
• MDR Text Key: 339333069
• Report Number: 3012304651-2024-00072
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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