Vitrax Sodium Hyaluronate Viscoelastic Solution

• • Terminated Z-0343-2009 FDA Unclassified (pre-2012) ·initiated 29 Oct 2008

  Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.

Full name

Amo(R) Vitrax(R) Viscoelastic Solution

Trade Name

Vitrax Sodium Hyaluronate

Generic Name

AID, SURGICAL, VISCOELASTIC

PMA Number

P880031 ↗

FDA Product Code

LZP

Device Class

Class III

Regulation

21 CFR Part 886.4275

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

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