FDA Medical Device Recalls (openFDA)
Johnson & Johnson Vision Care, Inc.: ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
- Recall number
- Z-1744-2020
- Recalling firm
- Johnson & Johnson Vision Care, Inc.
- Product
- ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
- Status
- Terminated
- Initiated
- 2017-12-18
- Posted
- not on file
- Terminated
- 2020-06-10
- Reason
- Package integrity failure observed during routine shift package integrity testing at an external re-packager.
- Root cause
- Packaging
- 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.
- Quantity
- 150 lenses.
- Distribution
- Nationwide US.
- Lot, serial or model codes
- Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
- 510(k) numbers
- ["K042275"]
- PMA numbers
- not on file
- Product code
- MVN
- Firm FEI
- 1000222023
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28