ISee Ortho-K Lens
Reported: September 13, 2023 Initiated: June 26, 2023 #Z-2515-2023
Product Description
ISee Ortho-K Lens
Reason for Recall
Manufactured lenses are not covered by existing FDA approval
Details
- Recalling Firm
- PARAGON VISION SCIENCES, Inc
- Units Affected
- 83,542 lenses
- 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 of Australia, Canada, China, Japan, Vietnam.
- Location
- Gilbert, AZ
Frequently Asked Questions
What product was recalled? ▼
ISee Ortho-K Lens. Recalled by PARAGON VISION SCIENCES, Inc. Units affected: 83,542 lenses.
Why was this product recalled? ▼
Manufactured lenses are not covered by existing FDA approval
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2023. Severity: Moderate. Recall number: Z-2515-2023.
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