Reported Nov 15, 2017 · Terminated

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on…

Aaren Scientific 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: Aaren Scientific Inc. · 1040 S Vintage Ave Ste A · Ontario, CA · 91761-3631

Is this the product you have?

  • AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.
Lot codes and dates
  • Lot numbers and expiration dates
    • 160204
    • 1/31/2018
    • 160505
    • 4/30/2018
    • 161006
    • 9/30/2018
    • 161018
    • 9/30/2018
    • 161028
    • 9/30/2018
    • 161219
    • 11/30/2018
    • and 170120
    • 12/31/2018
Amount recalled
786 boxes

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The recommended storage temperature on the label is incorrect.

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

Notice updated May 1, 2018 · Data as of Sep 19, 4:47 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.