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Z-1865-2021 Class II Terminated

Recalled by Johnson & Johnson Vision Care, Inc. — Jacksonville, FL

FDA device recall Z-1865-2021 was initiated by Johnson & Johnson Vision Care, Inc. on May 6, 2021 and is designated Class II. Reason for recall: Potential that a limited number of individual contact lens packages have an incomplete packaging seal. The recall status is terminated (terminated November 2, 2021). Affected quantity: 6,780 lenses.

Recall Details

Product Type: Devices
Report Date: June 23, 2021
Initiation Date: May 6, 2021
Termination Date: November 2, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,780 lenses

Product Description

ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

Reason for Recall

Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

Distribution Pattern

Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.

Code Information

UPC 733905989612 LOT # BOOWWWL

Other recalls by Johnson & Johnson Vision Care, Inc.

Z-2163-2025 Class II — ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL (June 12, 2025)
Z-1131-2019 Class II — ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Pow (March 11, 2019)
Z-2916-2018 Class II — Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, - (July 23, 2018)
Z-1744-2020 Class II — ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve (December 18, 2017)
Z-1210-2018 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR (October 19, 2017)
Z-1209-2018 Class II — ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS (October 19, 2017)
Z-1211-2018 Class II — 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses (October 19, 2017)
Z-1336-2013 Class II — ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact le (December 21, 2012)
Z-1335-2013 Class II — 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The (December 21, 2012)