ISee Ortho-K Lens recall
ISee Ortho-K Lens
Why was ISee Ortho-K Lens recalled?
Manufactured lenses are not covered by existing FDA approval
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots , DI-B22208
- Product
- ISee Ortho-K Lens
- Recalling firm
- PARAGON VISION SCIENCES, Inc
- Quantity
- 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.
- Recall date
- September 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)