FDA import alert

Import Alert 86-09

Detention Without Physical Examination of Excimer Lasers Manufactured for Export

9

Red-list entries

0

Green-list entries

5

Countries

2022-08-24

Last change seen

Official FDA source ↗Data refreshed 2026-07-11 UTC

What being on this list means

Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →

A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.

Red-list entries by country

CountryEntries
Germany3
United States3
Costa Rica1
Ireland1
Japan1

Firms on this red list

Showing 9 of 9 entries — search a specific firm on the free checker.

  • Lasersight Technologies Inclst Laser S.A.

    09/16/2009

    Costa Rica · Laser, System, Excimer

  • Bausch & Lomb/Technolas Gmbh

    08/24/2022

    Germany · Laser, System, Excimer

  • Chiron Technolas Gmbh

    09/16/2009

    Germany · Laser, System, Excimer

  • Technolas Gmbh

    08/24/2022

    Germany · Laser, System, Excimer

  • Summit Technology Ireland B.V.

    09/16/2009

    Ireland · Laser, System, Excimer

  • NIDEK Co., Ltd.

    09/16/2009

    Japan · Laser, System, Excimer

  • Alcon Refractive Horizons, Inc.

    09/16/2009

    United States · Laser, System, Excimer

  • Summit Technology, Inc.

    09/16/2009

    United States · Laser, System, Excimer

  • VISX Incorporated A Subsidiary of AMO Inc

    09/16/2009

    United States · Laser, System, Excimer

Does this alert touch your supply chain?

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