Home / Recalls / PARAGON VISION SCIENCES, Inc / Z-2515-2023

Z-2515-2023 Class II Ongoing

Recalled by PARAGON VISION SCIENCES, Inc — Gilbert, AZ

FDA device recall Z-2515-2023 was initiated by PARAGON VISION SCIENCES, Inc on June 26, 2023 and is designated Class II. Reason for recall: Manufactured lenses are not covered by existing FDA approval The recall status is ongoing. Affected quantity: 83,542 lenses.

Recall Details

Product Type: Devices
Report Date: September 13, 2023
Initiation Date: June 26, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 83,542 lenses

Product Description

ISee Ortho-K Lens

Reason for Recall

Manufactured lenses are not covered by existing FDA approval

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.

Code Information

All Lots , DI-B22208