Medical DeviceSep 13, 2023
PARAGON VISION SCIENCES ISee Ortho-K Lens recall — FDA Z-2515-2023
Manufactured lenses are not covered by existing FDA approval
Class IIFDA: OngoingPARAGON VISION SCIENCES, Inc.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceSep 13, 2023
PARAGON VISION SCIENCES Fargo Ortho-K Lens recall — FDA Z-2516-2023
Manufactured lenses are not covered by existing FDA approval
Class IIFDA: OngoingPARAGON VISION SCIENCES, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies PARAGON VISION SCIENCES, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.