Food, drugs, devices › Johnson & Johnson Vision Care, Inc.
Device recall: ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
FDA enforcement event 97095 is a device recall by Johnson & Johnson Vision Care, Inc. of Jacksonville, FL, initiated 12 Jun 2025 and classified Class II, with 1 product record.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Johnson & Johnson Vision Care, Inc. has 7 enforcement events on this register, with a median of 1 product record 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
Johnson & Johnson Vision Care, Inc., Jacksonville, FL.
Reason for recall
"Due to defects (bubbles/voids) identified during standard finished goods testing"
Distribution
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2163-2025 | ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL | 114,165 lenses | Class II | Ongoing | 30 Jul 2025 |
Context
Other enforcement events for Johnson & Johnson Vision Care, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 21 Dec 2012 | 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) C | Device | Class II | 2 |
All 7 events for Johnson & Johnson Vision Care, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to defects (bubbles/voids) identified during standard finished goods testing"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.