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TriVisc™ sodium hyaluronate

Avanos Medical, Inc. · Model 50653-0006-04 · UDI-DI 00850653006047

MOZ Prescription

510(k) clearances

8,423

Adverse events (310 deaths)

Recalls

Facilities

Description

TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).

Recalls

Date	Firm	Reason
2017-12-11	Sanofi Genzyme	Contamination with Methylbacterium thiocyanatum
2010-04-16	Ferring Pharmaceuticals Inc	Out of Specification results for molecular weight or viscosity through the established expiration date.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.