ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Medical device recall Z-2163-2025. Published in FDA’s Enforcement Report on Jul 30, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 30, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 32 states named
- 114,165 lenses how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to defects (bubbles/voids) identified during standard finished goods testing
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
114,165 lenses, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LOT_NUMBER / PRODUCT_DESCRIPTION / UPC Number J003QC7 1D MAX MULTIFOCAL 8.4 +0.00 LOW 90P RX 888290921027 J003QC8 1D MAX MULTIFOCAL 8.4 +0.50 LOW 90P RX 888290921041 003QC9 1D MAX MULTIFOCAL 8.4 +1.25 HGH 90P RX 888290920464 J003QCB 1D MAX…
Every code shown here, 1,995 characters
LOT_NUMBER / PRODUCT_DESCRIPTION / UPC Number J003QC7 1D MAX MULTIFOCAL 8.4 +0.00 LOW 90P RX 888290921027 J003QC8 1D MAX MULTIFOCAL 8.4 +0.50 LOW 90P RX 888290921041 003QC9 1D MAX MULTIFOCAL 8.4 +1.25 HGH 90P RX 888290920464 J003QCB 1D MAX MULTIFOCAL 8.4 +1.25 LOW 90P RX 888290921072 J003QCC 1D MAX MULTIFOCAL 8.4 +1.75 LOW 90P RX 888290921096 J003QCD 1D MAX MULTIFOCAL 8.4 +2.00 MID 90P RX 888290921713 J003QCG 1D MAX MULTIFOCAL 8.4 +2.75 MID 90P RX 888290921744 J003QCH 1D MAX MULTIFOCAL 8.4 -0.50 MID 90P RX 888290921614 J003QCJ 1D MAX MULTIFOCAL 8.4 -0.75 HGH 90P RX 888290920389 J003QHP 1D MAX MULTIFOCAL 8.4 -1.00 LOW 90P RX 888290920983 J003QCK 1D MAX MULTIFOCAL 8.4 -1.25 MID 90P RX 888290921584 J003Q71 1D MAX MULTIFOCAL 8.4 -1.75 MID 30P RX 888290919734 J003Q72 1D MAX MULTIFOCAL 8.4 -2.00 LOW 30P RX 888290919116 J003Q73 1D MAX MULTIFOCAL 8.4 -2.00 MID 30P RX 888290919727 J003Q74 1D MAX MULTIFOCAL 8.4 -2.25 LOW 30P RX 888290919109 J003QHT 1D MAX MULTIFOCAL 8.4 -2.25 LOW 90P RX 888290920938 J003Q75 1D MAX MULTIFOCAL 8.4 -2.25 MID 30P RX 888290919710 J003QCL 1D MAX MULTIFOCAL 8.4 -2.50 HGH 90P RX 888290920389 J003QCM 1D MAX MULTIFOCAL 8.4 -2.50 LOW 90P RX 888290920921 J003Q76 1D MAX MULTIFOCAL 8.4 -2.50 MID 30P RX 888290919703 J003QCQ 1D MAX MULTIFOCAL 8.4 -3.00 MID 90P RX 888290921515 J003QD0 1D MAX MULTIFOCAL 8.4 -3.50 MID 30P RX 888290919666 J003QM9 1D MAX MULTIFOCAL 8.4 -3.50 MID 90P RX 888290921492 J003QD3 1D MAX MULTIFOCAL 8.4 -4.00 LOW 30P RX 888290919031 J003QD4 1D MAX MULTIFOCAL 8.4 -4.00 MID 30P RX 888290919642 J003QD5 1D MAX MULTIFOCAL 8.4 -4.25 HGH 30P RX 888290918416 J003QD9 1D MAX MULTIFOCAL 8.4 -4.75 LOW 30P RX 888290919000 J003QDG 1D MAX MULTIFOCAL 8.4 -5.25 MID 30P RX 888290919598 J003QDH 1D MAX MULTIFOCAL 8.4 -5.50 LOW 30P RX 888290918973 J003QDK 1D MAX MULTIFOCAL 8.4 -5.75 HGH 30P RX 888290918355 J003QHW 1D MAX MULTIFOCAL 8.4 -6.50 MID 90P RX 888290921379 J003QBT 1D MAX MULTIFOCAL 8.4 -6.75 LOW 90P RX 888290920754 J003QCV 1D MAX MULTIFOCAL 8.4…
FDA’s list runs to 2,213 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.
The states and territories these words name
32 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 12, 2025.
- FDA classified it on Jul 23, 2025.
- FDA’s Enforcement Report published it on Jul 30, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Johnson & Johnson Vision Care, Inc., of Jacksonville, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,213 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.