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	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that one day post-operatively, the patient presented with small (<0.5 mm) hypopon with 3+ wbcs with fibrin strand/membrane formation.At the day two post-operative appointment, the observations were similar to that of day one; however, a slight improvement was noted.The healthcare facility has made a presumed diagnosis of toxic anterior segment syndrome (tass).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.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.The bioburden and endotoxin results for the subject batch are within acceptable tolerance therefore a rayner microbiological cause for the onset of post-operative tass is very unlikely.Our review of production records for the rayone emv rao200e batch 102201325 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 vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 102201325.
Event or Problem Description
On (b)(6) 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 one day post-operatively, the patient presented with a small layer of hypopon (<0.5 mm) with 3+ wbcs with fibrin strand/membrane formation.The presumed diagnosis in this case is toxic anterior segment syndrome (tass).

• 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: 19114018
• Report Number: 3012304651-2024-00087
• Device Sequence Number: 12540650
• Product Code: HQL
• UDI-Device Identifier: 05029867006647
• UDI-Public: (01)05029867006647
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2024
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 102201325
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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 Age: 73 YR
• Patient Sex: Male