FDA Medical Device Recalls (openFDA)
Johnson & Johnson Vision Care, Inc.: ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
- Recall number
- Z-1209-2018
- Recalling firm
- Johnson & Johnson Vision Care, Inc.
- Product
- ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
- Status
- Terminated
- Initiated
- 2017-10-19
- Posted
- not on file
- Terminated
- 2020-06-12
- Reason
- Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
- Root cause
- Packaging process control
- Action
- On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.
- Quantity
- 125,763
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
- Lot, serial or model codes
- Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland
- 510(k) numbers
- ["K042275"]
- PMA numbers
- ["P040045"]
- Product code
- LPM
- 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