Reported Sep 14, 2022 · Ongoing

Various eye packs, cataract packs

American Contract Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Contract Systems, Inc. · 2610 Ne Industrial Dr Ste 220 · Kansas City, MO · 64117-2648

Is this the product you have?

  • Various eye packs, cataract packs
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1BLSE37K, 2106292, 820211, 15017475-004
2MECA21P, 2108022, 786211, 44234851-005
3CMEY17AD, 2108301, 760211, 15101886-004
4CXEY80X, 2109083, 749211, 15109749-004
Amount recalled
4 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

Why it was recalled

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.