Recall Z-2163-2025— Johnson & Johnson Vision Care, Inc.

Name: FDA recall Z-2163-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Class II · Ongoing

Class II FDA medical device recall by Johnson & Johnson Vision Care, Inc., initiated 2025-06-12. It names one FDA 510(k) clearance: K210930. Product: ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL. Reason: Due to defects (bubbles/voids) identified during standard finished goods testing.

Recalling firm: Johnson & Johnson Vision Care, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-12
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K210930 — ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc.·cleared 2021-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

Reason for recall

Due to defects (bubbles/voids) identified during standard finished goods testing

Data sourced from openFDA. This site is unofficial and independent of the FDA.