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 Codes	Endophthalmitis (1835); Inflammation (1932)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The verbatim report received states that post-operatively the patient presented with endophthalmitis.The healthcare facility is reported to use reusable instruments expect for disposals like cannulas, phaco tips , ovd etc.The surgery is reported as being uncomplicated.The standard post-operative treatment course employed by the healthcare facility is that all patients get antibiotics, steroids , and nsaids for 4 weeks starting 3 days pre-op.They start at qid week 1 and taper down each week to qd at week 4.( qid , tid , bid and qd).They use bromofenac ( nsaid) prednisone ( steroid) and moxifloxacin as the antibiotic and all these evidently are in one drop regimens.Every batch of iols manufactured by rayner are tested for endotoxin and bioburden.Rayner's endotoxin acceptable tolerances are derived from bs en iso 11979-08 (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.A rayner microbiological cause for the onset of post-operative endophthalmitis is therefore very unlikely.Published literature identifies a number of pre-operative risk factors including; diabetes mellitus, immune compromise/hiv, chronic blepharitis, infection of the lacrimal drainage system, contaminated eye drops, contact lens wear and contralateral ocular prosthesis.There is insufficient information available currently to establish the root cause of the onset of endophthalmitis.Rayner is following up via its representatives in the usa to obtain additional information to facilitate further investigation of the event.
Event or Problem Description
On (b)(6) 2023, 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 presented with endophthalmitis.

• 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: 17361365
• Report Number: 3012304651-2023-00083
• Device Sequence Number: 17509531
• Product Code: HQL
• UDI-Device Identifier: 05029867006753
• UDI-Public: (01)05029867006753
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 06/21/2024
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 062193582
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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