510(k) Report

FDA applicant

Altacor, Ltd.

Theale1 decision1998–19981 recall

FDA records 1 decision for Altacor, Ltd. (Theale) in 1998: 1 original PMA approval. All are in product code LZP (Aid, Surgical, Viscoelastic). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Altacor, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Altacor, Ltd. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Altacor, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZPAid, Surgical, Viscoelastic1decision

What has FDA decided for it lately?

  • P960011Biolon 1% Sodium Hyaluronate Viscoelastic Surgical Aid FluidAltacor, Ltd. · 19981 recall

The one decision as Altacor, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P960011Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0…Oct 4, 2010