# FDA recall Z-2516-2023

> **PARAGON VISION SCIENCES, Inc** · Class II · device recall initiated 2023-06-26.

## Product

Fargo Ortho-K Lens

## Reason for recall

Manufactured lenses are not covered by existing FDA approval

## 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.

## Key facts

- **Recall number:** Z-2516-2023
- **Recalling firm:** PARAGON VISION SCIENCES, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-26
- **Report date:** 2023-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gilbert, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2023

## Citation

> AI Analytics. FDA recall Z-2516-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2516-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*