FDAJune 26, 2023device
ISee Ortho-K Lens
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Manufactured lenses are not covered by existing FDA approval
What to do
FDA enforcement status: Ongoing
Brands named
paragon vision sciencesparagonparagon vision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArtelon FlexBand Plus Ref: 41054 & 410572026-02-06
- FDAArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)2026-02-06
- FDAArtelon FlexBand Dynamic Matrix Ref: 310572026-02-06
- FDAPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S2025-10-13
- FDAFemiClear Daily Bladder Strength Dietary Supplement, 28 Count, UPC 817008020684, SKU FEM500602025-09-04
- FDAThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.2025-08-27
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m2025-08-18
- FDAEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH2022025-08-18
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →