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 Capsular Bag Tear (2639)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the iol deployed faster than anticipated into the bag resulting in capsule rupture.The healthcare professional extracted the rayone emv rao200e iol from the eye by cutting it in half and expanding the incision.Triamcinolone/ anterior vitrectomy was performed and an ma60ac iol was implanted into sulcus.A glaukos istent was also inserted,.Ovd was removed and the wound sutured and closed.On (b)(6) 2022, the patient was seen by the healthcare professional for suture removal.The patient's vision at the consultation was 6/6.The product associated with this event was discarded by the healthcare facility following explantation from the eye.The rayner risk analysis identifies advancing the plunger too quickly and forcing a jammed plunger during iol insertion as possible causes of capsule rupture.The information available states that this was the first time the surgeon had used rayner product, and this may be an influencing factor in this case.

Event Description

On 24th november 2022, rayner received notification from its australian affiliate of an event that occurred during use of a rayone emv rao200e.The event description provided states that the iol deployed faster than anticipated into the bag resulting in capsule rupture.

• 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: 15975476
• MDR Text Key: 308307538
• Report Number: 3012304651-2022-00120
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867006203
• UDI-Public: (01)05029867006203
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 092197890
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male