MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE

Model Number NOT AVAILABLE

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's post-operative outcome was not as expected and that examination identified that the capsular bag was bulging posteriorly.The patient underwent an additional surgical procedure one week post-operatively to resolve the bulging capsular bag and to improve their refractive outcome.The description of the lens bulging posteriorly suggests that residual ovd had been left behind the iol (capsular bag distension syndrome - cbds, capsular block).Cbds occurs when fluid accumulates between the iol and the posterior capsule, leading to a distention of the posterior capsule with anterior displacement of the iol.The trapped fluid develops a turbid consistency which leads to a decreased visual acuity for the patient and can be associated with either a myopic (most common) or hyperopic shift.Published literature and rayner's own risk analysis identifies the most common cause of cbds to be residual ovd in the eye.The "use of rayone" section of the ifu "fig 7" includes the instruction ".Following implantation, irrigate/aspirate to eliminate any ovd residues from the eye, especially behind the iol".Additionally, "deviation from target refraction" is listed in the "adverse events" section of the ifu.Rayner is following up with its distributor to obtain additional information to facilitate further investigation of the event including but not limited to: product lot number, patient medical history, ovd information and an overview of the surgical procedure.

Event Description

On (b)(6) 2023, rayner received notification from its distributor in the netherlands of an event that occurred following implantation of a rayone iol (model unknown at the time of this report).The event description provided states that the patient's post-operative outcome was not as expected and that examination identified that the capsular bag was bulging posteriorly.

• Brand Name: RAYONE
• Type of Device: RAYONE
• 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: 16500808
• MDR Text Key: 310856076
• Report Number: 3012304651-2023-00028
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Date Manufacturer Received: 02/20/2023
• 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