Medical device recalls Moderate risk

Staar Surgical Co. recalls STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

Recall date
May 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1964-2016
FDA classification
Class II
Brand / firm
Staar Surgical Co.
Sold / distributed
US

Why it was recalled

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

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