RegWardenFDA facility compliance records
Company

Johnson & Johnson Vision Care, Inc.

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2017: 2 recalls; 2018: 1 recalls; 2019: 1 recalls; 2021: 1 recalls; 2025: 1 recalls1’12’13’14’15’162’171’181’19’201’21’22’23’241’25’26
  • Recalls (7)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-06-12
    Due to defects (bubbles/voids) identified during standard finished goods testing
  • Class IITerminated2021-05-06
    Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
  • Class IITerminated2019-03-11
    One lot of ACUVUE OASYS® for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
  • Class IITerminated2018-07-23
    Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.
  • Class IITerminated2017-12-18
    Package integrity failure observed during routine shift package integrity testing at an external re-packager.
  • Class IITerminated2017-10-19
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • Class IITerminated2012-12-21
    Limited number of individual contact lens packages may not have been completely sealed.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Johnson & Johnson Vision Care, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1024871-johnson-johnson-vision-care-inc/

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