MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number RAO100C

Device Problem Mechanical Problem (1384)

Patient Problems Intraocular Infection (1933); Visual Impairment (2138)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that the iol haptic got trapped between the plunger and nozzle during injection necessitating lens explantation and device revision/replacement.The patient has pre-existing glaucoma and post-operatively is reported to have presented with visual impairment/disturbances, glaucoma and intraocular infection.Medication has been prescribed to the patient.The device associated with this event has been confirmed as available for return; however, to date, no product has been received by rayner for evaluation.The rayone preloaded iol injection system use risk analysis identifies the following as possible causes of "trapped/torn lens haptic/optic during insertion"; inadequate amount of viscoelastic, inadequate quality of viscoelastic, haptic trapped by plunger override due to fast motion, user opens closed flaps and closes again before use, plunger advanced too quickly, insertion of viscoelastic through nozzle leading to inadequate amount of viscoelastic, user removed injector from tray prior to inserting viscoelastic - causing lens to be improperly placed in cartridge, user removes injector from tray prior to closing cartridge - resulting in cartridge not being clipped closed properly and optic edge trapped/damaged on closure of cartridge.There is currently insufficient information available to determine the cause of the event.Rayner is following up with its affiliate company to obtain additional information to facilitate further investigation of the case.Our review of production records for the rayone spheric rao100c batch 021164823 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 (february 2021) 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 021164823.

Event Description

On (b)(6) 2021, rayner intraocular lenses limited received notification from its german affiliate company of an event that occurred during use of a rayone spheric rao100c.The event description provided states that the iol haptic got trapped between the plunger and the nozzle resulting in device explantation, revision and replacement.

Event Description

On 26th october 2021, rayner intraocular lenses limited received notification from its german affiliate company of an event that occurred during use of a rayone spheric rao100c.The event description provided states that the iol haptic got trapped between the plunger and the nozzle resulting in device explantation, revision and replacement.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that the iol haptic got trapped between the plunger and nozzle during injection necessitating lens explantation and device revision/replacement.The patient has pre-existing glaucoma and post-operatively is reported to have presented with visual impairment/disturbances, glaucoma and intraocular infection.Medication has been prescribed to the patient.The injector associated with this case was returned dehydrated in the outer packaging (product carton).The device underwent evaluation and preliminary inspection of the returned injector identified that the movable flaps were closed, and the plunger was fully retracted with its soft tip coming from the nozzle tip.To facilitate further inspection and testing of the device, the injector was disassembled.Following the disassembly, injector parts were inspected under 10x magnification.This cosmetic inspection showed that there was no damage to the plunger; however, shallow stress marks were observed to the injector nozzle.This is consistent with force being applied to the plunger during injection to deliver the lens.Following plunger removal, part of the iol haptic was found stuck in the nozzle.A methylene blue dye test was performed on the injector nozzle, which identified that there was an irregularity in the nozzle coating which could be an artefact of the lens getting trapped and the force required to free the lens.It was not possible from the product inspection performed to establish the definitive root cause in this case.Rayner performs comprehensive testing throughout its manufacturing process and in addition to the multi-stage 100% inspection rayner perform, one sample product from every batch is removed for qa batch control testing.This includes injection testing whereby injection performance, lens orientation and injector/lens condition post-injection is evaluated prior to the batch being released for distribution.Our qa batch control records confirm that this check was completed successfully, without incident, for the subject rayone spheric rao100c batch 021164823.A review of rayner's vigilance data confirms that there are no other incidents, of any nature, associated with the rayone spheric rao100c batch 021164823.

• 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: 12745608
• MDR Text Key: 279888942
• Report Number: 3012304651-2021-00051
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 021164823
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 83 YR
• Patient Sex: Male