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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92719

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 26, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PARAGON VISION SCIENCES, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

ISee Ortho-K Lens

Z-2515-2023
Recall number
Z-2515-2023
Initiated
June 26, 2023
Classification
Class II
Status
Ongoing
Quantity
83,542 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufactured lenses are not covered by existing FDA approval

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufactured lenses are not covered by existing FDA approval

Code information

All Lots , DI-B22208

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.

device · product 2 of 2

Fargo Ortho-K Lens

Z-2516-2023
Recall number
Z-2516-2023
Initiated
June 26, 2023
Classification
Class II
Status
Ongoing
Quantity
18,820 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufactured lenses are not covered by existing FDA approval

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufactured lenses are not covered by existing FDA approval

Code information

All Lots, DI - B22208

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.