Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

FDA Recall Z-1744-2020 · Posted None

Recalling FirmJohnson & Johnson Vision Care, Inc.
Recall StatusTerminated
Product CodeMVN
Date Initiated2017-12-18
Date Terminated2020-06-10
Product Quantity150 lenses.

Reason for Recall

Package integrity failure observed during routine shift package integrity testing at an external re-packager.

Firm Action

Johnson & Johnson Vision Care Inc., notified customers on 12/18/2017 via Recall Notification letter. Included with the Recall Notification Letter was a Customer Reply Form which the customer is instructed to fax back to the firm.

Root Cause

Packaging

Distribution Pattern

Nationwide US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENSVistakon · 2004-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑