Recall Z-2982-2018— Alden Optical
Class III · Terminated
Class III FDA medical device recall by Alden Optical, initiated 2018-07-03, terminated 2020-02-28. It names 3 FDA 510(k) clearances: K071266, K071043, K033594. Product: 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.. Reason: Vials labeled for the prescriptions contained incorrect lenses.
- Recalling firm
- Alden Optical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-07-03
- Terminated
- 2020-02-28
- Firm location
- Lancaster, NY, United States
510(k) clearances named in this recall
3 on FDA's record- K071266 — BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
- K071043 — BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
- K033594 — OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Vials labeled for the prescriptions contained incorrect lenses
Data sourced from openFDA. This site is unofficial and independent of the FDA.