Reported Sep 12, 2018 · Terminated
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC…
Alden Optical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alden Optical · 6 Lancaster Pkwy · Lancaster, NY · 14086-9713
Is this the product you have?
- Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc
- polycarbonate vial (Rx)as followsZen RC TPC (Toric Peripheral Curve) Zen RC
- FT (Front Toric Optics) Catalog NumberAOZNT 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
- Lot codes and dates
- B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008
- Amount recalled
- 4 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Vials labeled for the prescriptions contained incorrect lenses
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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