Recall Z-2982-2018 ยท HQD Lens, Contact (Other Material) - Daily
Alden Optical
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | Vials labeled for the prescriptions contained incorrect lenses |
| Root cause | Process control |
| Action | The firm, Alden Optical, notified customers of an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" by phone and follow-up letter on 7/3/18. The letter described product, problem and actions to be taken. The customers were instructed to check your inventory; return the affected lenses via email with return shipping labels provided by email. Customers requested to notify patients if the lens has been dispensed or distributed, and have the patient return the lens(es), and complete the enclosed Business Response Card and return it to Alden Optical via U.S. Mail within 5 days. If you have any questio |
| Quantity | 4 vials |
| Distribution | US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd., Mar 19, 2004 |
| K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES Bausch & Lomb, Inc., Aug 2, 2007 |
| K071266 | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Inc., Aug 15, 2007 |