Reported Aug 23, 2023 · Ongoing

Alcon Custom Pak

Alcon Research, Ltd.

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: Alcon Research, LTD. · 714 Columbia Ave · Sinking Spring, PA · 19608-1405

Is this the product you have?

  • Alcon Custom Pak
Lot codes and dates
  • 3,117 of 3,117 codes

    • Catalog No. Catalog #
    • 0007-67
    • 0091-69
    • 0210-70
    • 0302-82
    • 0349-78
    • 0365-75
    • 0437-38
    • 0680-74
    • 0693-66
    • 0781-63
    • 0815-68
    • 0880-41
    • 0888-69
    • 0900-28
    • 0938-60
    • 0956-69
    • 0995-82
    • 10008-16
    • 10014-63
    • 10014-64
    • 10019-15
    • 10027-12
    • 10066-19
    • 10101-16
    • 10101-17
    • 10101-18
    • 10101-20
    • 10166-16
    • 10214-17
    • 10214-19
    • 10222-21
    • 10222-22
    • 10223-16
    • 10223-17
    • 10223-18
    • 10264-15
    • 10275-17
    • 10308-11
    • 10342-17
    • 10356-15
    • 10421-28
    • 10477-20
    • 10482-15
    • 10557-11
    • 10557-12
    • 10558-11
    • 10558-12
    • 10568-13
    • 10572-19
    • 10575-17
    • 10594-14
    • 10632-20
    • 10638-27
    • 10731-20
    • 10735-21
    • 10772-34
    • 10782-28
    • 10804-17
    • 10825-17
Amount recalled
1,682,351 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 6:59 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.