Device recall: 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic)…
Class II FDA enforcement event 64468. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Limited number of individual contact lens packages may not have been completely sealed.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Vision Care, Inc. started this device recall on 21 Dec 2012. The firm address in the FDA record is in Jacksonville, FL. FDA put the recall in Class II. FDA event 64468 has 2 product records. The first FDA enforcement report date is 22 May 2013. The record gives the status Terminated, with the termination date 5 Jul 2013.
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.
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico;…
Recalling firm
Johnson & Johnson Vision Care, Inc., Jacksonville, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1335-2013 | 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye… | 36,330 lenses | Class II | Terminated | 22 May 2013 |
| Z-1336-2013 | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less. | 3546 lenses | Class II | Terminated | 22 May 2013 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Jun 2025 | ACUVUE OASYS MAX 1-Day MULTIFOCAL | Device | Class II | 1 |
| 6 May 2021 | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50 | Device | Class II | 1 |
| 11 Mar 2019 | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack. | Device | Class II | 1 |
| 23 Jul 2018 | Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 sp | Device | Class II | 1 |
| 18 Dec 2017 | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90. | Device | Class II | 1 |
| 19 Oct 2017 | ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-1335-2013The 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 64468. https://recallregister.com/fda/ii/64468/. 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:
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico;…
- What quantity of product is in FDA event 64468?
- The event has 2 product records. The first record gives this quantity:
36,330 lenses
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.