MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number RAO100C

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

Patient Problem Rupture (2208)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states "during injection the first haptic goes down and then unfolds fast damaging the capsule".The description of the lens unfolding fast may suggest that injection was completed too quickly.The rayone ifu "use of rayone" section "fig 7" states "press the plunger in a slow and controlled manner".The rayone risk analysis identifies the following as possible causes of capsule rupture; plunger advanced too quickly, forcing jammed plunger during iol insertion and lens delivered in 's' orientation.Posterior capsule rupture is a known complication associated with cataract surgery.The rcophth nod national cataract audit report 2020 gives a rate of (b)(4)% for posterior capsule rupture.Rayner's rate of posterior capsule rupture for its rayone hydrophilic iol models is (b)(4)%.Our review of production records for the rayone spheric rao100c batch 040153643 showed that all manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.A review of existing vigilance data from the month of manufacture of the rayone spheric rao100c (april 2020) was carried out to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the rayone spheric rao100c batch 040153643.

Event Description

On (b)(6) 2021, rayner intraocular lenses limited received notification from its (b)(6) distributor of an event that occured during use of a rayone spheric rao100c.The verbatim report received states "during injection the first haptic goes down and then unfolds fast damaging the capsule".

• Brand Name: RAYONE SPHERIC
• Type of Device: RAYONE SPHERIC
• 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: 11306929
• MDR Text Key: 231171996
• Report Number: 3012304651-2021-00005
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867690600
• UDI-Public: (01)05029867690600
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 040153643
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/10/2021
• 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