Medical Device recall. Alcon Laboratories. The “CyPass Micro-Stent”....

The CyPass Micro-Stent is used to treat open angle glaucoma during cataract surgery.  In 2016 the CyPass Micro-Stent was approved by the US FDA based on 2 year data. Due to the critical nature of the device (it is inserted into the eye), and the potential for longer term adverse effects, the FDA required longer term data collection as part of the device approval. Based on information from these post-approval studies, there were indications of differing degrees of corneal cell loss between patients subject to the device and those not exposed to the device. Also, there were indications of differing endothelial cell densities between the two groups of patients. As a result Alcon have initiated a voluntary product recall.

FDA consideration:
The FDA states that it will continue to work with Alcon on evaluating the data.

FDA statement >>>
Medical Device Validation and Risk Management

Medical Device Validation and Risk Management

This raises a number of questions. Getting products to market is in the benefit of the product developer and the patient. New improved products are of great benefit to patients. However, there is a line somewhere between prompt release to market and ensuring a safe effective device. In this case was two years too short? Then again, would it be reasonable to force such products to have to demonstrate 5, even 10 year data, before release?

Such decisions will be based on comprehensive risk assessments. Any product designed for use in the eye region will be considered to operate in the high risk area. Review of equivalent products in the market, will help identify potential problems. Experience of device material corneal cell interactions will need to input into the risk process.

Risk evaluation and mitigation is not an exact science, but all those involved in inputting into risk identification, measurement, mitigation, etc., must have a comprehensive understanding of up to date risk management methods.


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Information and training presentation on Medical Device Validation, Regulation & Compliance >>>