Device recall: clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti…
Class III FDA enforcement event 79755. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The secondary packaging is labeled with an incorrect expiration date.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
CooperVision Inc. started this device recall on 21 Feb 2018. The firm address in the FDA record is in W Henrietta, NY. FDA put the recall in Class III. FDA event 79755 has 4 product records. The first FDA enforcement report date is 2 May 2018. The record gives the status Terminated, with the termination date 2 Oct 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
Recalling firm
CooperVision Inc., W Henrietta, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1515-2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in… | 22 packs/1980 lenses | Class III | Terminated | 2 May 2018 |
| Z-1516-2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or… | 32 packs/2880 lenses | Class III | Terminated | 2 May 2018 |
| Z-1517-2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic… | 328 packs/3280 lenses | Class III | Terminated | 2 May 2018 |
| Z-1518-2018 | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic… | 105 packs/1050 lenses | Class III | Terminated | 2 May 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class III
- 4%
- Product records in this event
- 4Median of the firm: 2
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-1515-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 79755. https://recallregister.com/fda/iii/79755/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
- What quantity of product is in FDA event 79755?
- The event has 4 product records. The first record gives this quantity:
22 packs/1980 lenses
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 4% of the 1,074 device events that started in 2018 are in Class III.