MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference c240375 has been allocated to this case by rayner.The event description provided states that the patient underwent implantation of a rayone emv rao200e iol on (b)(6) 2023 and on an unknown date post-operatively presented with opacification of the iol.The patient's visual acuity was impacted as a result of the onset of opacification.Opacification is reported to have been unresolved by yag therefore necessitating explantation.The iol was explanted and exchanged on an unknown date post-operativley.The timing of onset is quite soon for a potential posterior capsule opacification (pco) case as this is more usually noted in the 2 to 5 year date range after implantation due to the slow growth rate of lecs.This also applies to typical cases of post-operative opacification or calcification (whereby calcium phosphate deposits are identified on the lens via scanning electron microscopy analysis).There are certain patient conditions that may increase the likelihood of deposits developing within the eye post-operatively including but not limited to; glaucoma, diabetes, pseudoexfoliation syndrome.There is insufficient evidence and information available at this time to establish root cause of the reported "opacification".Rayner is following up to obtain additional evidence and information via its representatives in the us to facilitate further investigation of this event.
Event or Problem Description
On 13th february 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 opacification of the iol was observed and that visual acuity declined as a result necessitating iol explantation.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient underwent implantation of a rayone emv rao200e iol on (b)(6) 2023 and on an unknown date post-operatively presented with opacification of the iol.The patient's visual acuity was impacted as a result of the onset of opacification.Opacification is reported to have been unresolved by yag therefore necessitating explantation.The iol was explanted and exchanged on an unknown date post-operativley.The timing of onset is quite soon for a potential posterior capsule opacification (pco) case as this is more usually noted in the 2 to 5 year date range after implantation due to the slow growth rate of lecs.This also applies to typical cases of post-operative opacification or calcification (whereby calcium phosphate deposits are identified on the lens via scanning electron microscopy analysis).There are certain patient conditions that may increase the likelihood of deposits developing within the eye post-operatively including but not limited to; glaucoma, diabetes, pseudoexfoliation syndrome.The explanted lens was retained and returned to rayner.As the report concerned the post-operative onset of opacification, the returned explanted lens was sent to a third party independent laboratory to undergo analysis.Scanning electron microscopy did not show any visual evidence of calcification.Energy dispersive x-ray spectroscopy did not indicate any elemental (calcium and phosphate) evidence of calcification.Alizirin red testing was performed as an additional action in this case and this did not bind or strain any calcium on the explanted lens.The analysis performed confirms that the lens is free of calcification.There is no fault of the rayner device.
Event or Problem Description
On 13th february 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 opacification of the iol was observed and that visual acuity declined as a result necessitating iol explantation.

• 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: 18823456
• Report Number: 3012304651-2024-00049
• Device Sequence Number: 7308643
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: (01)05029867006685
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 06193468
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/03/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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