ReNu Lawsuit & News Blog

FDA MedWatch- NuCel Labs Eye Drops and Eye/Ear Wash- Nationwide Recall Because Of The Presence Of Bacteria And Particulate Matter

Thu, 31 Jan 2008 14:27:28 -0500

NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/War Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries have been reported to date. There are no lot numbers or expiration dates on the products. Consumers who have the product should discontinue use of the product and return it to NuCel Lab. See the manufacturer's press release for return shipping information.

Read the complete 2008 MedWatch Safety Summary, including a link to the Manufacturer's Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#NuCel

Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products
Contact:
Kevin Lundquist
208-542-0325

FOR IMMEDIATE RELEASE -- January 29, 2008 -- NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.

Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled "Eye Drops Caution: Do Not Use With Implants" or "Eye/Ear Wash" are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.

No illnesses or injuries have been reported to date.

The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full refund. Consumers with questions may call NuCel Lab at 208-542-0325.

AMO Complete MoisturePlus Linked to Acanthamoeba Keratitis

Fri, 22 Jun 2007 11:12:26 -0500

The use of a particular contact lens solution manufactured by Advanced Medical Optics has a strong association with Acanthamoeba keratitis, a rare severe eye infection, according to a recent study at University of Illinois at Chicago (UIC).

AK (acanthamoeba keratatis) is a severe, painful infection of the cornea that commonly causes corneal scarring and sometimes blindness.

In the last three and half years, UIC has seen 63 cases of the infections, compared to the two or three cases a year we would normally expect to see. In their study, researchers compared 38 AK patients with 100 controls, all of whom were UIC clinic patients between 2003 and 2006. All participants were asked to fill out a survey.

Survey questions focused on the six-month period prior to symptoms and targeted three areas: water exposure; contact lens hygiene, including solutions and lens types; and other habits associated with contact lens use. Participants were provided with color images of the contact lens solution bottles to help them recall what type they had used.

Among soft contact lens wearers, participants with AK were significantly more likely to report having exclusively used AMO Complete MoisturePlus than the control group (55.2 percent vs. 10.5 percent).
The results correlated with previously published laboratory studies that showed that Acanthamoeba is largely resistant to contact lens solutions in general and to Complete MoisturePlus in particular.

source: http://www.news-medical.net/?id=26461

Bausch & Lomb Still Reeling from ReNu with MoistureLoc Recall

Thu, 21 Jun 2007 11:15:14 -0500

With a minimum of 400 consumer lawsuits over last year's recall of ReNu with MoistureLoc contact lens solution, Bausch & Lomb posted a disappointing May 2007 financial report. The earnings report, which is for the first quarter of 2006, was filed late, in part because Bausch & Lomb needed time to assess the financial losses caused by the recall.

According to the report, the Renu MoistureLoc recall reduced Bausch & Lomb's first quarter 2006 net income by $19.6 million dollars.

Bausch & Lomb's troubles began in 2006, when ReNu with MoistureLoc became linked to fusarium keratatis, a rare eye infection that may cause potential blindness.

Bausch & Lomb pulled MoistureLoc from Asian markets in February 2006, and did the same in the United States in April 2006, before finally issuing a worldwide recall in May 2006.

As of June 30, 2006, the Centers for Disease Control (CDC) confirmed 164 cases of the eye infection. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that that contact lens solution appeared to have poor disinfectant qualities.

In October 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations at its Greenville, South Carolina manufacturing plant.

In March 2007, Bausch & Lomb issued a voluntary recall of another contact lens product, Renu Multiplus Solution, for having trace amounts of iron. The Multiplus Solution is also manufactured at Greenville. The iron could lead to a shortened shelf life for the solution.

Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the MoistureLoc debacle, although some have predicted that the amount will be much higher.

source: http://www.newsinferno.com/archives/1582

Bausch & Lomb Case Moves to Federal Court

Wed, 20 Jun 2007 11:16:51 -0500

Bausch & Lomb has denied allegations of negligence relating to a Texas' man's eye infection as lawyers prepare for a conference in federal court.

On March 20, plaintiffs filed a suit in Jefferson County, Texas, naming Bausch & Lomb Inc., Wal-Mart Stores Inc., and three employees of the store's vision center and pharmacy as defendants.

According to the plaintiffs' original petition, he had worn contact lenses since July 2005 and purchased Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution at a Lumberton, Texas Wal-Mart.

In early May 2006, Pouch began experiencing pain and loss of vision in his right eye. On May 23, 2006, he consulted with a doctor at the Wal-Mart Vision Center who eventually diagnosed him with Fusarium Keratitis, a fungal infection.

It was subsequently learned by plaintiffs that Bausch & Lomb and the other defendants knew that Bausch & Lomb's product, ReNu with MoistureLoc Multi-Purpose Solution, was causing Fusarium Keratitis in individuals around the world.

On May 18, U.S. District Court Judge Thad Heartfield for the Eastern District of Texas accepted the case and set a June 8 deadline for an attorney conference to discuss settlement options and if parties are willing to go to trial.

Souce: http://www.setexasrecord.com/news/196303-bausch--lomb-responds-to-suit-as-case-moves-to-federal-court

Complete MoisturePlus Contact Lens Solution Recalled

Thu, 14 Jun 2007 07:03:17 -0500

Advanced Medical Optics, the company who manufactures Complete MoisturePlus contact lens solution voluntarily recalled the contact lens solution because it has been linked to an increased risk for a rare but serious eye infection.

Contact lens wearers who are using this contact lens care product, should discontinue its use and also dispose of any current pair of lenses and the lens case.

On May 26, the Centers for Disease Control and Prevention (CDC) issued a public health alert about an increased risk of Acanthamoeba keratitis, a serious eye infection, among contact lens wearers. The recent outbreak of eye infections is now being linked primarily to Complete Moisture Plus No-Rub contact lens solution.

The CDC and the Food and Drug Administration are investigating 138 cases of Acanthamoeba keratitis that have developed since Jan. 1, 2005.

Acanthamoeba keratitis is a rare by potentially blinding eye infection. The infection is caused by a microscopic, free-living amoeba called Acanthamoeba, which can invade the transparent outer covering of the eye called the cornea. These amoebas are very common in nature and can be found in all areas of the environment, including water, soil, and air.

Early diagnosis is important for the treatment of Acanthamoeba keratitis. The infection is usually diagnosed by an eye specialist based on symptoms, growth of the amoeba from a scraping of the eye, and/or seeing the amoeba by a process called confocal microscopy. The infection is treated with one or more prescription eye medications. The infection can sometimes be difficult to treat.

source: http://www.eyecareamerica.org/eyecare/news/keratitis_alert_may07.cfm

What is the problem with Complete MoisturePLUS?

Wed, 13 Jun 2007 08:46:50 -0500

This product has been linked to eye infections - AK (Acanthamoeba Keratitis). AK is potentially blinding, if left untreated. Acanthamoeba occurs in nature. It is usually in soil and water. It has been found in air conditioning units. But the concentration is usually too low to cause a problem and only occurs 1 in 2,000,000 lens wearers. Usually it happens when there is not sufficient cleaning of lenses after swimming in a pool or hot tub. AK infections can cause blindness or permanent eye damage.

Who is AMO - Advanced Medical Optics?: AMO is a company that makes eye products. They are based in Santa Ana CA. They hold about 10% of the contact lens solution market share. However, this percent has dropped since the product was pulled from the market due to the AK infections.

There are now over 100 cases reported to the CDC with AK from users of AMO Complete. Users have 7-times the risk of infection as a result of the product.

How do I contact the FDA is I was injured by AMO Complete?

Tue, 12 Jun 2007 08:38:16 -0500

The FDA can be contacted at 800-FDA-0178. MedWatch is on the lookout for these problems and is eager to learn of individuals having eye infection problems from AMO. AK - Acanthamoeba Keratitis is a rare and very dangerours eye infection and needs immediate medical attention. With so many AMO patients suffering this problem, the product has been linked to causing the infections in many users.

What is Complete MoisturePLUS?

Mon, 11 Jun 2007 08:44:40 -0500

CompelteMoisturePLUS is an "all in one" multi-purpose solution for contact lens cleaning and care. It is used for soft contact lenses. It is made by AMO (Advanced Medical Optics, Inc.), a California based company.

What should I do if I used AMO Complete with MoisturePLUS?

Sun, 10 Jun 2007 08:52:16 -0500

Here are the legal steps we suggest:

1. Stop using th eproduct
2. Make sure no one else uses this product - especially children. Your child who uses this product is probably not aware of the recall.
3. Lock away any un-used product.
4. Discard soft contact lenses that have been exposed to the product
5. Discard any lenses and containers storing the product.
6. Consult Your Eye doctor immediately. Be particularly dilligent if you think you have symptoms of an eye infection. Be sure to tell them of the use of this product and the recent recall
7. Consult a lawyer if you intend to bring legal action.

Acanthamoeba Eye Infection

Sat, 9 Jun 2007 07:05:09 -0500

Source: http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm

Acanthamoeba is a microscopic, free-living ameba that is relatively common in the environment. This ameba has been isolated from water (including natural and treated water in pools or hot tubs), soil, air associated with cooling towers, heating, ventilation and air conditioner systems, sewage systems, and drinking water systems (shower heads, taps). Most people will be exposed to Acanthamoeba during their lifetime and will not get sick. However, Acanthamoeba is capable of causing several infections in humans.

Acanthamoeba keratitis is an infection of the eye that occurs in healthy persons and can result in permanent visual impairment or blindness. The infection is caused when a microscopic, free-living ameba called Acanthamoeba invades the transparent outer covering of the eye called the cornea.