Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). 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.
FDA Recall Z-2981-2018 · Posted None
Advertisement
Recalling FirmAlden Optical
Recall StatusTerminated
Product CodeHQD
Date Initiated2018-07-03
Date Terminated2020-02-28
Product Quantity36 vials
Reason for Recall
Vials labeled for the prescriptions contained incorrect lenses
Firm 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 questions regarding this recall, please contact Alden Optical Customer Service at 1-800-253-3669.
Root Cause
Process control
Distribution Pattern
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K071266BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENSBausch & Lomb, Inc. · 2007-08-15K071043BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSESBausch & Lomb, Inc. · 2007-08-02K033594OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESContamac, Ltd. · 2004-03-19
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement