MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the posterior capsule ruptured during iol implantation.The rayone aspheric rao600c was explanted, an anterior vitrectomy was performed and a sulcus iol was implanted.The verbatim report received states that posterior capsule rupture occurred as a result of the plunger over shooting.This indicates that significant force was applied to the plunger causing the plunger soft-tip to extend beyond the end of the nozzle resulting in explosive expulsion of the iol.The rayone ifu "use of rayone" states "press the plunger in a slow and controlled manner.If excessive resistance is felt this could indicate a blockage; stop and discard the lens".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 acrylic iol models is (b)(4)%.

Event Description

On 22nd september 2020, rayner intraocular lenses limited received notification from a (b)(6) healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states "during insertion of the iol there was a pc rupture caused by the injector plunger over shooting".

• Brand Name: RAYONE ASPHERIC
• Type of Device: RAYONE ASPHERIC
• 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: 10579955
• MDR Text Key: 208375057
• Report Number: 3012304651-2020-00021
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691591
• UDI-Public: (01)05029867691591
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 040152667
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• 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