MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 4th september 2024, rayner received notification from a us healthcare facility of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that post-operatively, the patient has presented with toxic anterior segment syndrome (tass).
Additional Manufacturer Narrative
The reference: (b)(4) has been allocated to this case by rayner.The event description provided states that the patient presented with toxic anterior segment syndrome (tass) post-operatively.The aetiology of tass may be multi-factorial with numerous potential causes including but not limited to; bacterial endotoxins or particulate contamination of balanced salt solutions, intraocular irrigating solutions with abnormal ph, osmolarity or ionic composition, denatured ophthalmic viscosurgical devices (ovd), intraocular medications (antibiotics in the irrigation solutions or intracameral antibiotics),topical ointments, inadequate sterilization of surgical instruments and tubing, inadequate flushing of instruments between cases resulting in build-up of ophthalmic viscosurgical devices (ovd),preservative and metallic precipitate.Every batch of iols manufactured by rayner are tested for endotoxin and bioburden prior to release for sale.Rayner's endotoxin acceptable tolerances are derived from bs en iso11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own limits for bioburden as there is no standard that prescribes acceptable limits.I can confirm that the records for the rayone emv rao200e batch 073221651 show that the bioburden and endotoxin results are within the defined limits.A rayner microbiological cause for the onset of post-operative tass is therefore extremely unlikely.Rayner has been advised that the healthcare facility has completed their own internal investigation and believes the viscoelastic is the cause of the post-operative onset of tass in this case.

• Brand Name: RAYONE EMV
• Common Device Name: 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: 20358595
• Report Number: 3012304651-2024-00255
• Device Sequence Number: 18145629
• Product Code: HQL
• UDI-Device Identifier: 05029867006692
• UDI-Public: 05029867006692
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2025
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 073221651
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown