Gilbert, AZ, United States
PARAGON VISION SCIENCES, Inc recalls
1 recall recorded since 2018, most recently on 26 June 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 June 2023
- Reason
- Manufactured lenses are not covered by existing FDA approval
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2515-2023, Z-2516-2023
- ISee Ortho-K Lens
- Fargo Ortho-K Lens
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.