PARAGON VISION SCIENCES, Inc Recall 92719
Description: ISee Ortho-K Lens
PARAGON VISION SCIENCES, Inc Recall 92719 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2515-2023 |
| Event ID | 92719 |
| Event Description | ISee Ortho-K Lens |
| Product Type | Devices |
| 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. |
| Quantity | 83,542 lenses |
| Recall Reason | Manufactured lenses are not covered by existing FDA approval |
| Device Classification | 20230913 |
| Device Code Info | All Lots , DI-B22208 |
| Center Classification Date | 20230905 |
| Recall Initiation Date | 20230626 |
| Recalling Firm | PARAGON VISION SCIENCES, Inc |
| Initial Notification | Letter |
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