Scope of Problem
An estimated 1 million units of balanced salt solution were distributed between December 2003 and December 2005 under the brand names AMO Endosol (Advanced Medical Optics), Cytosol Ophthalmics (Cytosol Ophthalmics), and Akorn (Akorn Inc).
Hospitals, healthcare professionals, and consumers are advised to stop using the product immediately and return unused portions to the company. Additional information regarding returns may be obtained by contacting the company at 1-800-366-6554.
Individuals with questions concerning the recall may contact the FDA at 1-888-463-6332.
Balanced salt solution is used to irrigate the eyes, ears, nose, and throat during surgery.
Healthcare professionals are encouraged to report adverse events related to use of balanced salt solution to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Visit MedWatch: The FDA Safety and Adverse Event Reporting System |
