Recalled - now back again?

listing the following ingredients: a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose and polypropylene glycol PGC as lubricants, phospate & taurine as buffers, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edentate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water.

POLYPROPYLENE GLYCOL is an alcohol Source

PGC an eye irritant

Molecular Formula:

(C3H6O)nH2O

Belongs to the Following Reactive Group(s)

Alcohols and Polyols

Do no Harm *

On April 13, 2005, the FDA approved AMO's Complete MoisturePLUS. This time, AMO represented that Complete MoisturePLUS was "the same as the currently marketed solution." But it wasn't just like it, because MoisturePLUS contained two additional ingredients, propylene glycol (used as antifreeze in automobile radiators) and taurine (used as a specialized buffer).

e-mail private comment to Armand Rossetti: I looked into the most commonly used glycol ether, 2-butoxyethanol, for a number of years because someone in my family was harmed by it when spraying the beaches with this chemical during the Exxon Valdez oil spill cleanup, 1989

I've learned that the glycol ethers (family of chemicals it belongs to) can cause loss of eyesight, loss of hearing, loss of senses of taste and smell. http://www.valdezlink.com/re/glycolether.htm

Exposure looks like 'the flu' It causes autoimmune issues and cancers and what civilians call CFIDS, CFS, FM and military call the 'gulf war syndrome'

My husband used this product in 2007 and his eyes were burning and hurting. Exposure to glycol ether causes eyes to burn and hurt. I set this aside to complain about it some day, and just realized that it had been recalled.

I thought about this because he just had an eye exam and whatever the eye doctor used on his contacts, caused his eyes to burn and hurt. NOT a good sign if you want to save your vision. http://www.valdezlink.com/re/drugs/list.htm

Propylene glycol is NOT a good ingredient.

Used on a regular basis people should develop FATIGUE, and CFIDS assortment of symptoms. 8-24-09

recall

AMO Complete® MoisturePlus™ Contact Lens Solution Linked to Microbial Keratitis

New Eye Infection, AMO Recall its Complete MoisturePlus Contact Lens Solution
A Dangerous Contact Lens Solution Linked to Acanthamoeba Kera titis & Microbial Keratitis in Addition to Fungal Keratitis. Have your eyes been, once again, placed in danger of Bacterial Eye Infections, vision damage, or loss of sight?

On May 25, AMO (Advanced Medical Optics) announced a recall of their 'No Rub' Complete MoisturePlus Multipurpose Contact Solution. Although the company stands by its product and casts the blame on contact lens wearers who 'improperly store, disinfect or handle' their contact lenses, the CDC forced AMO to recall Complete Moisture Plus.

This Complete Moisture Plus recall is not so distant from Bausch & Lomb's recall of ReNu with MoistureLoc, which caused serious injury to many contact lens wearers. AMO's press release states they have known since January of 2005 about at least 46 patients who claimed to have contracted a unique form of keratitis from the AMO Recall solution.

This keratitis is called 'acanthamoeba keratitis (AK)'. From all indications, AMO Moisture Plus recall was delayed as long as Bausch did in coming forward and r ecalling the product; potentially exposing an untold number of unsuspecting contact lens wearers to this painful (AK) infection that can cause permanent vision loss or blindness.

Other reports seem to illustrate a company who knew about the potential link between (AK) and their Complete MoisturePlus Multipurpose Solution since as early as 2004. In 2004, the infection first occurred in more than a dozen people against the normal count of one or two in a year. Dr. Elmer Tu, an ophthalmologist at the University of Illinois, Chicago, along with other doctors attended around 35 patients from May 2003 to September of 2006, 55% of whom were infected due to usage of AMO Complete MoisturePlus recall solution.

According to Dr. Tu, AMO's Complete MoisturePLUS solution is not defective. It is just not designed to provide a shield to the eyes when they're exposed to soil or water where the risk of bacterial infection is significant. Julie Zawisza, an FDA spokes person, said,' The solution is not marketed to protect against the amoeba. But it's supposed to be free of any type of microorganisms. It's not supposed to result in anyone getting an infection.'

Once again, one must wonder what corporations who suspect problems with their products are thinking when they wait one, two, or more years before warning the public about a potential hazard provoked or caused by their product. We wonder how much injury must occur bef ore corporate dollars are sufficient.

Acanthamoeba keratitis & Microbial Keratitis patients suffer symptoms very similar to other common bacterial eye infection, but the AK infection can result in the loss of eye sight. If you experience symptoms, including the following, we encourage you to first immediately seek treatment from an experienced, eye care professional:

' Eye pain
' Eye redness and soreness
' Hypersensitivity to light
' Reduction in visual acuity
' Temporary or, at the worst, permanent blindness

http://www.malaysianbabes.net/forum/AMO-Complete-MoisturePlus-Contact-Lens-Solution-Linked-to-Microbial-Keratitis-t22935.html

Contact lens solution recall-- AMO Complete Moisture Plus Multi-Purpose Solution May 28, 2007

Health officials and eye doctors are puzzled by an outbreak of a rare but potentially blinding eye infection that led the manufacturer of a contact lens cleaning solution to withdraw one of its products this weekend.

The outbreak resembles one last year that was linked to a different manufacturer’s lens solution and a different microbe. In both instances, the cornea, the eye’s transparent outer covering, is at risk. But why two different microbes caused the outbreaks is not known.

“It is beyond comprehension,” said Dr. Dan B. Jones, the chairman of ophthalmology at Baylor College of Medicine in Houston, who detected a case of acanthamoeba keratitis, which is behind the current outbreak, on Friday.

Acanthamoeba keratitis is caused by a parasite, can be difficult to detect and is hard to treat. This outbreak has involved at least 138 patients.

Read more: http://www.nytimes.com/2007/05/28/us/28eyes.html?hp

Flash back to last November: http://www.consumeraffairs.com/news04/2006/11/moisturep...

Advanced Medical Optics Inc. is recalling 2.9 million packets of its Complete MoisturePlus multipurpose contact-lens solution and Active Packs, after it found bacterial contamination in three lots sold in Japan.

The recall includes 183,000 units sold in the U.S.

The company, based in Santa Ana, Calif., blamed the the contamination on a water-borne organism that got into some solution at the company's plant in China. The plant has been shut down until the problem can be resolved, the company said. Advanced Medical said there is no problem with the lens solution's formula.

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=102x2860889

What are the so-called "ancillary ingredients" in AMO's Complete MoisturePLUS?

Armand Rossetti

Contributor

June 15, 2007

On two prior occasions, AMO had submitted 510(K) summaries to the FDA for marketing approval for Complete brand Multi-Purpose Solution. The FDA approved the first 510(K) on February 12, 2003 , and the second on April 4, 2003. The second summary stated a comprehensive device description, listing the following ingredients: a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edentate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water.

Hydroxypropyl methylcellulose is mainly used as dispersant in the production of PVC and as thickener, stabilizer, emulsifier, excipient, water retention agent, film-forming agent in petrochemical, building materials, agrochemical, ink, printing and dyeing of textile, paper making, cosmetic, etc. The "etc" must also include contact lens solutions.

What was missing in this picture when AMO decided to file another 510(k) for FDA approval of Complete MoisturePLUS Multi-Purpose Disinfecting Solution?

In its 510(k) submission, AMO presented the FDA with following generalized device description for Complete MoisturePLUS: "a sterile, isotonic, buffered, solution containing lubricants, preservatives, buffers, surfactants, ancillary ingredients, and purified water."

AMO's above-described scant description ensured that the FDA would have no clue that additional ingredients were included in a new formulation, much less any indication that MoisturePLUS was not "the same as the currently marketed solution," i.e., Complete brand Multi-purpose Solution.

What about taurine? etc

http://westpalmbeach.injuryboard.com/miscellaneous/what-are-the-so-called-ancillary-ingredients-in-amos-complete-moistureplus.aspx?googleid=218952

And today?

Abbott Medical Optics has acquired Advanced Medical Optics. amo

amo-inc.com/products/corneal/multi-purpose-solution/complete-multi-purpose-solution-easy-rub-formula

Notice as well that Complete is now "MPS Easy Rub", and that the formula has changed from was once AMO Complete MoisturePlus. Nevertheless, the valuable trademark showing a wave and splash (most likely a house mark that identifies more than one product a belonging to a family of products) and accompanying color scheme...remain the same. Both AMO's Blink and Clean and its Lubricating and Rewetting Drops also display the same trademarked logo.

amo-inc.com/products/corneal/contact-lens-lubricating-and-rewetting-eye-drops/complete-blink-n-clean-lens-drops

Propylene glycol and Taurine are no longer a part of the new Complete contact lens care solution; you should always consult with your eye care specialist before using any contact lens care solution, and whenever using such solution(s) and/or contact lens/solution combination cause the least bit of ocular discomfort.

I would suspect, however, that there is some type of glycol ether in this formulation, as well. Which is the kind of chemical that causes loss of eyesight and more.