MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED SULCOFLEX

Model Number NOT AVAILABLE

Device Problem 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 event description provided states that post-operatively the patient has presented with opacification of the supplementary sulcoflex iol.No further event information is available to rayner at this time.Additional information has been requested from the reporter to facilitate further investigation of the event."precipitates" is listed in the "adverse events" section of the ifu.Primary calcification is inherent.It is due to particular manufacturing processes or packaging interactions.An examination of the literature shows that some manufacturers have had known cases of primary calcification due to an interaction with silicone in the packaging - and more recently, due to phosphate remnants (originating from a detergent) found in the manufacturing process.Rayner has made no material processing or packaging changes that may have negatively affected our iols; we have never had a confirmed case of primary calcification relating to a rayner iol.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.There is insufficient evidence and information available to establish the root cause of the onset of post-operative iol opacification in this case.

Event Description

On (b)(6) 2023, rayner received notification from a uk healthcare facility of an event that occurred following implantation of a supplementary sulcoflex iol (model unspecified).The event description provided states that post-operatively, the patient has presented with opacification of the iol.Note: supplementary sulcoflex iols are not available in the usa; however, as they're manufactured from the same hydrophilic acrylic material as rayner models licensed for sale in the usa, the event is being reported to fda.

• Brand Name: SULCOFLEX
• Type of Device: SULCOFLEX
• 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: 17910455
• MDR Text Key: 325353243
• Report Number: 3012304651-2023-00137
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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