MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problems Calcified (1077); Material Opacification (1426)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

The reference(b)(4) has been allocated to this case by rayner.The patient underwent combined phaco, trabulectomy and iol implantation on (b)(6) 2019.While the reporter has not been explicit in disclosing patient medical history, the indication for trabulectomy surgery is glaucoma.The patient is also reported to use timolol eye drops (indicated for treatment of ocular hypertension, chronic open angle glaucoma and secondary glaucoma) twice daily in both eyes.The event description provided states that the patient has been complaining of low vision for approximately six months and that following examination the healthcare professional observed the onset of iol opacification.Slit lamp photographs have been made available to rayner for review which confirm the presence of deposits on the lens; however, the nature and/or origin of the deposits cannot be established unless the lens is returned for analysis (scanning electron microscopy and energy dispersive x-ray fluorescence).The healthcare facility has indicated that it is their intention to explant the lens.Rayner has requested the return of the lens post explant for third-party independent laboratory analysis.Rayner ifus contraindicate "¿ active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication")."precipitates" is listed in the "adverse events" section of the ifu.Secondary calcification affects many manufacturers and is a phenomenon that is not fully understood; it is known that it stems from changes in the eye's environment due to patient comorbidity, secondary surgeries and potentially other, poorly understood interactions: off label use of intracameral alteplase (actilyse) (rtpa), multifactorial, high phosphate content ophthalmic viscoelastic devices, repeated exposure to intracameral air, raised intraocular pressure, excessive post-operative inflammation, complicated, traumatised eyes, as a result of direct contact between the iol surface and the exogenous gas or substance, a metabolic change in the anterior chamber due to the presence of exogenous gas/substance in the eye or an exacerbated inflammatory reaction after multiple surgical procedures, trauma or repeat surgery involved in re-bubbling potentially disrupting the blood aqueous barrier, increasing concentration of calcium ions.The patient's pre-existing medical history is suspected to be a contributory factory to the onset of opacification in this case.

Event Description

On (b)(6) 2021, rayner intraocular lenses limited received notification from its (b)(4) distributor of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that post-operatively the onset of iol opacification had been observed leading to a decline in the patient's visual acuity.

Manufacturer Narrative

The reference c21529 has been allocated to this case by rayner.The event description provided states that iol opacification was observed post-operatively leading to a decline in patient visual acuity.The patient underwent combined phaco, trabulectomy and iol implantation on (b)(6) 2019.While the reporter has not been explict in disclosing patient medical history, the indication for trabulectomy surgery is glaucoma.The patient is also reported to use timolol eye drops (indicated for treatment of ocular hypertension, chronic open angle glaucoma and secondary glaucoma) twice daily in both eyes.The patient is reported to have complained of low vision for approximately six months prior to iol opacification being observed under slit lamp examination.The rayone aspheric rao600c was explanted on (b)(6) 2021.The lens was retained and returned to rayner for evaluation.Scanning electron microscopy (sem) and energy dispersive x-ray spectroscopy (edx) analysis of the explanted iol was completed by a third-party independent laboratory on (b)(6) 2021.Sem and eds analysis revealed a significant deposition of mineral like structures on the surface of the iol consistent with the structure and form of iol calcification.The crystals were composed of calcium phosphate.Secondary calcification affects many manufacturers and is a phenomenon that is not fully understood; it is known that it stems from changes in the eye's environment due to patient comorbidity, secondary surgeries and potentially other, poorly understood interactions: off label use of intracameral alteplase (actilyse) (rtpa), multifactorial, high phosphate content ophthalmic viscoelastic devices, repeated exposure to intracameral air, raised intraocular pressure, excessive post-operative inflammation, complicated, traumatised eyes, as a result of direct contact between the iol surface and the exogenous gas or substance, a metabolic change in the anterior chamber due to the presence of exogenous gas/substance in the eye or an exacerbated inflammatory reaction after multiple surgical procedures, trauma or repeat surgery involved in re-bubbling potentially disrupting the blood aqueous barrier, increasing concentration of calcium ions.Rayner ifus contraindicate "· active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication")."precipitates" is listed in the "adverse events" section of the ifu.The patient medical history and continuous use of drops could be a contributory factor to the onset of post-operative calcification in this case.

Event Description

On (b)(6) 2021, rayner intraocular lenses limited received notification from its brazilian distributor of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that post-operatively the onset of iol opacification had been observed leading to a decline in patient visual acuity.

• Brand Name: RAYONE ASPHERIC
• Type of Device: RAYONE ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• MDR Report Key: 12202625
• MDR Text Key: 263475734
• Report Number: 3012304651-2021-00027
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691669
• UDI-Public: (01)05029867691669
• Combination Product (y/n): N
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 118127863
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR