Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.

Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients. To date, Alcon Laboratories has not received any reports of adverse events related to this recall.

Systane Lubricant Eye Drops Ultra PF is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms and is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative free solution for ophthalmic use (NDC 0065-1432-06, UPC 300651432060). The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size. Please see product images included in this release. Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide to retail and internet outlets.

Consumers that have the recalled Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) which is being recalled should stop using them immediately and return to the place of purchase for a replacement or refund. Consumers with questions regarding this recall can contact Alcon Laboratories at 1-800-241-5999 between 7:30am and 6:00pm (Central), Monday to Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Alcon Laboratories is notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products. Distributors or retailers should discard any remaining stock of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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The 14 physicians and more than 100 staff of Columbia Eye Clinic welcome Danlin Jenny Fuller, M.D. to the practice.  Dr. Fuller specializes in ophthalmic and cataract surgery and comprehensive ophthalmology.  Her clinical interest is in comprehensive eye care including cataracts and laser assisted cataract surgery, glaucoma diagnosis and treatment, dry eye management, and eyelid surgery.  She sees patients at Columbia Eye Clinic’s three conveniently located offices in downtown Columbia, Northeast Columbia and Lexington.

Dr. Fuller completed her Residency at Augusta University Medical Center, Augusta, GA.  She earned her M.D. from Jefferson College of Medicine, Philadelphia, PA and completed her Internship at The Reading Hospital and Medical Center, Reading, PA.  She graduated from Pennsylvania State University, University City, PA with a B.S.  She is a member of the American Academy of Ophthalmology, American Medical Association, and American Society of Cataract & Refractive Surgery.

Dr. Fuller enjoys scuba diving, traveling, rock climbing, photography and is a certified yoga instructor.  She is fluent in Mandarin Chinese.

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The fourteen physicians and more than 100 staff of Columbia Eye Clinic welcome Derrick A. Huey, M.D. to the practice.  He is excited to relocate to the Midlands to join the largest and most advanced medical surgical Ophthalmology practice in the Midlands after practicing in Charleston.

Dr. Huey specializes in Ophthalmic and Cataract Surgery and comprehensive Ophthalmology. His clinical interests include:

• Presbyopia and Astigmatism Correcting Cataract Surgery,
• Medical and Laser Management of Glaucoma,
• Dry Eye Management,
• Pterygium Excision,
• Management of Ocular Inflammation and Uveitis.

He will see patients at Columbia Eye Clinic’s three conveniently located offices in downtown Columbia, Northeast Columbia and Lexington.

Dr. Huey completed his Residency at the Medical University of South Carolina Storm Eye Institute in Charleston, SC where he served as Chief Resident for ocular trauma management.   He earned his M.D. and completed his Internship at the Medical University of South Carolina-Charleston, SC.  He graduated from the College of Charleston-Charleston, SC with a B.S.  He is a member of the American Academy of Ophthalmology, American Medical Association, South Carolina Medical Association and Alpha Omega Alpha Medical Honor Society.

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