MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number RAO100C

Device Problem Material Opacification (1426)

Patient Problem Visual Impairment (2138)

Event Date 09/09/2023

Event Type  malfunction  

Event Description

On 13th september 2023, rayner received notification from an indian healthcare facility of an event that occurred following implantation of a rayone spheric rao100c.The event description provided states that opacification of the iol was observed 15 days post-operatively.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that 15 days post-operatively the patient presented with iol opacification.The patient's vision is reported as 6/12p.Given the short time between surgery and the observation being made, it is possible to consider a number of potential causes which could be explored; the main candidates being pco, capsular block (from any residual ovd left behind the lens taking on water and swelling, becoming cloudy and forcing the lens out of position) and fibrin reaction.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.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 has contacted the reporting healthcare professional to obtain additional information to facilitate further investigation of the event.Our review of production records for the rayone spheric rao100c batch 013208088 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 existing vigilance data confirms that this is an isolated event.This review concluded that no other incidents, of any type, have been received against the rayone spheric rao100c batch 013208088.

• Brand Name: RAYONE SPHERIC
• Type of Device: RAYONE SPHERIC
• 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: 17833599
• MDR Text Key: 324462968
• Report Number: 3012304651-2023-00117
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867690662
• UDI-Public: (01)05029867690662
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 013208088
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female