Contact Lens Solution Recall

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From the companies website:

If the residual hydrogen peroxide is above product specification the user of the product could experience temporary symptoms of burning/stinging, irritation, red eye and in rare circumstances other more serious health consequences

The consumer really got an eyeful with this one. Ouch.
 






Excess peroxide can remain inside the container after disinfection, which is out of spec. The majority of the peroxide is neutralized over time by a piece inside the container, and if any is left over, it briefly irritates the eyes when the wearer inserts them into his or her eyes.

Anyone who wears contacts with peroxide cleaners knows that this happens a LOT on the cheaper, discount store-brand peroxide solutions and their cheap containers. We put up with it to save a buck, but it's an annoyance because it requires removing the lenses and doing a quick rinse with saline solution.

The consumer pays extra for PeroxiClear, so it's just making sure that the consumer isn't disappointed and the product isn't lumped in, mentally, with the cheap stuff.

Those of us who wear contact lenses are willing to do the extra rinse(s) with the cheap stuff because we know what we're getting into. I've personally never needed to do it with PeroxiClear, which is why I choose it and I pay extra for it.
 






Nothing like a strong dose of peroxide in the eye in the morning with your coffee to give you that extra pep for the day. Is this a design flaw or a manufacturing issue?
 












anonymous said:
What is the impact of these toxic doses of hydrogen peroxide on ocular health?
Click to expand...

There's no toxicity. It's just a mild burning sensation and it's something that any peroxide cleaning customer is used to. It's not really a big deal because the cheaper, generic store-brand solutions have much lower manufacturing tolerances and less quality control.

I think this is more or less to just ensure that higher standards than generic store-brand are maintained.

With PeroxiClear, the container is definitely much higher quality than generic store-brand. The neutralization element has gold or silver molecules on it which react with the peroxide and make bubbles. As the bubbles are made, the peroxide slowly becomes inert. If there's a little peroxide left in the inert solution that doesn't "burn off", there's a mild burning sensation when you insert the contact lens.

Either the eye waters it away or, if you're like me, you pop out the lens and wash it off with saline solution.

It's worth noting that I've never had a problem with PeroxiClear personally, and I have sensitive eyes. I always have problems with the generic store-bought peroxide in terms of burning sensation.
 






anonymous said:
There's no toxicity. It's just a mild burning sensation and it's something that any peroxide cleaning customer is used to. It's not really a big deal because the cheaper, generic store-brand solutions have much lower manufacturing tolerances and less quality control.

I think this is more or less to just ensure that higher standards than generic store-brand are maintained.

With PeroxiClear, the container is definitely much higher quality than generic store-brand. The neutralization element has gold or silver molecules on it which react with the peroxide and make bubbles. As the bubbles are made, the peroxide slowly becomes inert. If there's a little peroxide left in the inert solution that doesn't "burn off", there's a mild burning sensation when you insert the contact lens.

Either the eye waters it away or, if you're like me, you pop out the lens and wash it off with saline solution.

It's worth noting that I've never had a problem with PeroxiClear personally, and I have sensitive eyes. I always have problems with the generic store-bought peroxide in terms of burning sensation.
Click to expand...
 






anonymous said:
There's no toxicity. It's just a mild burning sensation and it's something that any peroxide cleaning customer is used to. It's not really a big deal because the cheaper, generic store-brand solutions have much lower manufacturing tolerances and less quality control.

I think this is more or less to just ensure that higher standards than generic store-brand are maintained.

With PeroxiClear, the container is definitely much higher quality than generic store-brand. The neutralization element has gold or silver molecules on it which react with the peroxide and make bubbles. As the bubbles are made, the peroxide slowly becomes inert. If there's a little peroxide left in the inert solution that doesn't "burn off", there's a mild burning sensation when you insert the contact lens.

Either the eye waters it away or, if you're like me, you pop out the lens and wash it off with saline solution.

It's worth noting that I've never had a problem with PeroxiClear personally, and I have sensitive eyes. I always have problems with the generic store-bought peroxide in terms of burning sensation.
Click to expand...
 






So this one customer knows exactly what is happening to all of the PeroxiClear customers that have experienced the end result of getting peroxide in the eye. Seems like this customer has a lot of inside information on the product recall. Maybe a public relations firm or a very loyal employee of the company doing damage control.
 
























This issue has been going on for 2 years. It's been under investigation for a whole year, culminating in feckless management trying to blame it on the customers wearing makeup, smoking, etc. It wasn't until the FDA popped in for a little visit that we realize "Oh sh1t, this product sucks" THEN we initiated the recall. It's ridiculous. There's obviously something going on with the neutralization disc, but you think anyone around here know how to find out root cause? Nope.

For all we know, the FDA might say Class 2 recall is not good enough, and have us make it a Class 1. Wouldn't surprise me.
 






Oh, and BTW those generic peroxide systems are repackaged Peroxiclear or Clearcare (depending on the brand and store). that's how generics work. The store gets to slap their name on something and charge less for it, and we get a little extra money.
 






anonymous said:
This issue has been going on for 2 years. It's been under investigation for a whole year, culminating in feckless management trying to blame it on the customers wearing makeup, smoking, etc. It wasn't until the FDA popped in for a little visit that we realize "Oh sh1t, this product sucks" THEN we initiated the recall. It's ridiculous. There's obviously something going on with the neutralization disc, but you think anyone around here know how to find out root cause? Nope.

For all we know, the FDA might say Class 2 recall is not good enough, and have us make it a Class 1. Wouldn't surprise me.
Click to expand...

Looks like a design problem. Too bad the irritation-toxicity problem was not detected earlier.
 






Memories of moistureloc anyone? Almost brought down B+L before and here we are again...Valeant cast all the quality and experienced folks to save money...so no surprise another lenscare disaster is upon them
 












There will have to be a root cause analysis first. After the root cause is determined the degree and impact of the problem needs to be determined. Is it lot specific or a problem with the entire product? Problem with the solution or the case?

As part of pharacoviligence an adverse event may have been reported. The cause and the pharacoviligence report should be thorough and complete. Getting this product back on the market will depend on how complete the report is and whether it covers all the possible issues with the problem identified. My guess is that the possibility of adverse events will likely have to be reduced to an extremely low level for it to go back on the market.

If the root cause is not determined -- if the product could cause AE over what is typical for this product category-- then forget it.
 












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