PARAGON VISION SCIENCES, Inc: Medical Device Recall in 2023 - (Recall #: Z-2515-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ISee Ortho-K Lens

Product Classification:

Class II

Date Initiated: June 26, 2023

Date Posted: September 13, 2023

Recall Number: Z-2515-2023

Event ID: 92719

Reason for Recall:

Manufactured lenses are not covered by existing FDA approval

Status: Ongoing

Product Quantity: 83,542 lenses

Code Information:

All Lots , DI-B22208

Distribution Pattern:

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 of Australia, Canada, China, Japan, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated