Device recall: Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Fron
FDA enforcement event 80800 is a device recall by Alden Optical of Lancaster, NY, initiated 3 Jul 2018 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 28 Feb 2020. Initiation: voluntary: firm initiated. Alden Optical has 2 enforcement events on this register, with a median of 11 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alden Optical, Lancaster, NY.
Reason for recall
"Vials labeled for the prescriptions contained incorrect lenses"
Distribution
"US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2981-2018 | 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… | 36 vials | Class III | Terminated | 12 Sep 2018 |
| Z-2982-2018 | 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,… | 4 vials | Class III | Terminated | 12 Sep 2018 |
Context
Other enforcement events for Alden Optical
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Nov 2017 | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for da | Device | Class II | 11 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Vials labeled for the prescriptions contained incorrect lenses"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Feb 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.