|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cytosol Ophthalmics Assets For SaleApril 10, 2006 For Immediate Release (Lenoir, NC) Cytosol Ophthalmics-Lenoir, Inc. has placed all its assets for sale in an effort to raise the funds necessary to compensate those affected by the recently announced recall. The assets for sale include our cohesive ophthalmic viscosurgical device ShellgelTM, our ophthalmic irrigation technology, and our recently expanded manufacturing facility located in Lenoir, NC. If you have any interest in any of the above assets, please contact Court Lewis at 1-828-758-2343 ext. 309. ### Endotoxin UpdateFebruary 18, 2006 For Immediate Release (Lenoir, NC) Dear Ophthalmic Community, Cytosol Ophthalmics has received a total of 2 complaints of TASS following cataract surgery in which Cytosol brand ophthalmic irrigant was used. These 2 complaints involved 5 patients, two at one center and three at another. These adverse reactions occurred in July-October of last year. Our products continued to be used until February 10th, 2006. We did not receive a single additional complaint from October-February 10th, 2006. From October 2005 through January 2006 we retested our irrigation products for endotoxin more than 2000 times. We found zero units above the limit of .25 EU/mL. Cytosol Ophthalmics has always and will always put patient safety first in any decision we make. I personally decided not to recall our product in November of last year when similar products were recalled. This was due to the safety profile and test results outlined above. Please do not confuse any of the above information with the fact that you must stop using our irrigation products immediately. In the U.S., you are instructed to return any unused product to us for the FDA to witness its destruction. Internationally, you can dispose of the product but only after notifying us of the quantity to be destroyed. I want to personally thank all the members of the ophthalmic community who have supported us over the past 12 years and especially those that sent kind words in the past week. Those words, calls, and emails are what keep us moving forward. I know many of you are struggling to source product right now, especially in those countries where we have significant market share. I want to thank Alcon Laboratories for expediting product to several locations so that surgery could continue. We are working as fast as we can to reestablish a supply of product. Please continue to monitor our website for updates on our progress. Best regards,
Cytosol Laboratories Issues Voluntary RecallFebruary 15, 2006 URGENT: DRUG RECALLBALANCED SALT SOLUTIONTo whom it may concern: This letter is to inform you that Cytosol Laboratories, Inc., is voluntarily recalling all Balanced Salt Solution manufactured in their facility in Braintree, Massachusetts. Balanced Salt Solution is used to irrigate a patient’s eyes, ears, and/or throat during a variety of surgical procedures including cataract surgeries. The following Balanced Salt Solution products/part numbers are included in this voluntary recall:
Cytosol Laboratories, Inc., is recalling the product because it has been reported to us that patients have experienced Toxic Anterior Segment Syndrome (TASS), which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. The presence of endotoxins in elevated levels in these products can represent a serious hazard to health. Our records show that your facility has received at least one shipment of the affected product. Please complete the attached Verification Form. If you have distributed any of the recalled products, please immediately contact your accounts, advise them of the recall situation, and have them follow the directions on the attached Verification Form. International product may be destroyed onsite but U.S. product must be returned to us. Also, request your distributors to conduct sub-recalls to the user level of physicians and hospitals. Please discontinue all distribution of Balanced Salt Solution manufactured by Cytosol Laboratories, Inc. This voluntary recall is being made with the knowledge of the Food and Drug Administration (FDA). Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Other Instructions In order for us to verify the effectiveness of this recall, it is imperative that after you receive this written notification that you complete and return the attached Verification Form to us. Fax the Form to us at 1-828-758-2345. Cytosol Ophthalmics, can be contacted at 1-800-234-5166 or 1-828-758-2343. Questions regarding this letter can be faxed to Cytosol Ophthalmics, at 1-828-758-2345, or submitted in writing to:
Cytosol Ophthalmics regrets any inconvenience this action may cause and thanks you for your cooperation. Best regards,
Court Lewis
VERIFICATION FORMFebruary 15, 2006 PLEASE FILL OUT AND RETURN BY FAX FAX # 1-828-758-2345 We do have stock of Balanced Salt Solution (in any presentation) manufactured by Cytosol Laboratories, Inc. Yes ( ) No( ) Domestic Customers And Distributors: We have requested (if applicable) our accounts to return their stock of Balanced Salt Solution manufactured by Cytosol Laboratories, Inc. that is affected by this recall. Yes ( ) No ( )
We are returning a total of ____________ (bottles or cases) of the product affected by this recall. Return any stock of Balanced Salt Solution to: Cytosol Ophthalmics 1325 William White Place Lenoir, NC 28645 International Customers And Distributors: We have requested (if applicable) our accounts to destroy their stock of Balanced Salt Solution manufactured by Cytosol Laboratories, Inc. that is affected by this recall. Yes ( ) No ( )
We are destroying a total of ____________ (bottles or cases) of the product affected by this recall. Please list the following information about the destroyed product:
All Customers:
Name________________________Name of Facility___________________________
Address__________________________________City_________________________
State_____________Country____________________________________
Post Code__________Telephone Number_____________________
Cytosol Confirms Product SafetyNovember 16, 2005 FOR IMMEDIATE RELEASE CYTOSOL OPHTHALMICS CONFIRMS PRODUCT SAFETY Cytosol Ophthalmics brand Balanced Salt Solution products have undergone extensive testing and retesting in the past week and no adverse results have been found. We would like to thank our independent testing labs for assisting us with our review. Cytosol Ophthalmics continues to ship all of our irrigation products to the large base of customers we support every day in the U.S. as well as to more than 35 other countries. Cytosol Ophthalmics has added several new customers in the past few days and we welcome them to the Cytosol family. If you are looking for a new supplier of ophthalmic irrigants, please call us at 1-800-234-5166 or visit our website, www.cytosol.com. Best regards, Court Lewis President Cytosol Ophthalmics # # # Shellgel Approved in EUMay 27, 2005 Lenoir, NC - FOR IMMEDIATE RELEASE 1325 Willliam White Place, NE Cytosol Ophthalmics - Lenoir, Inc. has announced that it has received European Union approval for its Shellgel 1.2% sodium hyaluronate viscoelastic product. The approval certifies the CE mark for Shellgel and permits the sale of Shellgel into the EU. Shellgel, a cohesive medium viscosity viscoelastic used for a variety of ophthalmic surgical procedures including cataract, glaucoma and corneal transplant is FDA approved and has been on the market in the U.S. since 2001. The Shellgel technology is manufactured by Anika Therapeutics, Inc. of Woburn, MA under an exclusive license to Cytosol Ophthalmics. "With this EU approval, we have completed CE registrations for all of our current product line from Cytosol Ophthalmics", indicates Ron Clarke, VP Sales & Marketing. "This includes our flagship product line, Cytosol Brand Balanced Salt Irrigation Solutions, ExactEtch microsurgical stainless steel knives and ExactPack custom ophthalmic procedure trays." Mr. Clarke adds, "The demand from our European distributors for a 'natural'-based viscoelastic product has been great. U.S. made product is in high demand in the European community. The Euro/Dollar ratio also helps our export position which is a real strength for Cytosol." Mr. Court Lewis, President of Cytosol Ophthalmics says that "We expect the addition of Shellgel to our Distribution partners in the European Community will more than double our current Shellgel business. The Shellgel unit growth is doubling each year and has become one of our most significant product launches in the company history. We are excited to be able to provide this product to our strong European partners. The Shellgel product is already experiencing good growth in Asia and Central and South America." About Cytosol Ophthalmics - Cytosol is a privately held corporation based in Western North Carolina, USA. Cytosol manufactures and distributes ophthalmic surgical products throughout the U.S. as well as over 40 countries around the world. Cytosol also operates its own business, Cytosol Ophthalmics-Australia, plc., based in Sydney. These products are distributed under Cytosol brand names, Cytosol balanced salt irrigation solutions, ExactEtch microsurgical knives, Shellgel viscoelastic, and ExactPack ophthalmic procedure trays. The products are also private labeled for other major multi-national ophthalmic companies. For information, please contact: |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ©2005 Cytosol Ophthalmics 1325 William White Place NE Lenoir, NC 28645 Phone: 1-800-234-5166 Fax: 1-828-758-2345 products | about us | employment | links | news releases | OEM | sterilization an art dude graphics design. |
