IA #95-02, 8/13/01, "DWPE OF INFRARED VISION LASER ILLUMINATORS AND SCOPES
FROM RUSSIA THAT INCORPORATE A LASER ILLUMINATOR"

NOTE:     This revision is being issued to revise the alert into the current
format and terminology.  Changes are bracketed by asterisks (***).

TYPE OF
ALERT:    *** Detention Without Physical Examination (DWPE)

     NOTE:     This import alert represents the Agency's current guidance to FDA
          field personnel regarding the manufacturer(s) and/or products(s)
          at issue.  It does not create or confer any rights for or on any
          person, and does not operate to bind FDA or the public. ***

PRODUCT:  Infrared Laser Illuminators (a.k.a. night vision illuminators and
          scopes which incorporate a laser illuminator). Scopes without the
          laser illuminator are not subject to DWPE.

PRODUCT
CODE:          95L[][]22

PROBLEM:  Fails to Meet Performance Standard

PAF:      PER (Performance)

PAC:      *** 86007 ***

COUNTRY:  *** Russia (RU) ***

MANUFACTURER
ID:       *** All manufacturers from Russia

          See attachment for firms known to manufacture and ship infrared
          night vision laser illuminators and scopes.***

IMPORTER'S
ID:       N/A

CHARGE:   If device is noncompliant with applicable standard and/or lacks
          certification, charge:

          "The article is subject to refusal of admission pursuant to
          Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
          in that it appears to be an electronic product which fails to
          comply with an applicable standard as prescribed under this
          subchapter or to which is not affixed a certification in the form
          of a label or tag in conformity with Section 534(h)."

          If no reporting is done, charge:

          "The article is subject to refusal of admission pursuant to
          Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
          in that it appears to be an electronic product that does not
          comply with an applicable standard as prescribed by Section 534
          because no reporting has been provided as required by Section
          537(b)."

OASIS CHARGE
CODE:          No Tag

RECOMMENDING
OFFICE:   CDRH, OC, Division of Compliance Operations (HFZ-323)

REASON FOR
ALERT:    CDRH/Division of Compliance Operations has identified infrared
          night vision laser illuminators and scopes from Russian
          manufacturers as violating Sections 536, 537 and 538 of the FFDCA
          and 21 CFR 1002.10 and as being potentially hazardous laser
          products.  The products have no certification that complies with
          the appropriate performance standard for laser products and no
          initial report from Russian manufacturers have been received by
          CDRH.

GUIDANCE: *** Districts may detain without physical examination infrared
          night vision laser illuminators and scopes from Russia lacking
          certificates, initial reports, or user instructions.  Products
          should be refused entry unless the importer corrects the product
          deficiencies or is able to show that the product is properly
          certified and meets the performance Standards (21 CFR 1010.2 and
          1010.3).  It may be necessary to field test some products to
          ensure the importer has effected the correction of the detained
          product.  Contact CDRH at (301) 427-1172 for additional guidance.
          Also contact CDRH for information regarding submission of required
          reports and guidelines for detention.

          For questions or issues concerning science, science policy, sample
          collection, analysis, preparation, or analytical methodology,
          contact the Division of Field Science at (301) 827-7605. ***

PRIORITIZATION
GUIDANCE: N/A

FOI:      No purging is required

KEYWORDS: Infrared Night Vision, Infrared Laser Illuminators, Night Vision
          Scopes, Night Vision Laser Illuminators, Scopes

PREPARED
BY:       Linda A. Wisniowski, DIOP, (301) 443-6553.

DATE LOADED
INTO FIARS:




             IMPORT ALERT #95-02 ATTACHMENT 8/30/01

FIRMS RECOMMENDED FOR DWPE KNOWN RUSSIAN MANUFACTURERS/SHIPPERS OF INFRARED
NIGHT VISION LASER ILLUMINATORS AND SCOPES


NIMP
Novosibrisk, Siberia
Russia
FEI #1000134061

Ratio
Ul. Tvardovskogo, 5-3-426
Moscow, 123, Russia
FEI #1000141916

Rostov Optical-Mechanical Plant
       (or Rostovskiy Optico-Mechanicheskiy Plant)
Savinskoye, Schosse
Rostov, Yaroslavl Region 152100
Russia
FEI #1000134060

Rotan
78 Jurinsky Street
Novo Sibrisk
Russia
FEI #1000141780

Talus Corporation
Malyi Momsomolskyi Per, 6
Moscow, 101863
Russia
FEI #1000141781

VIZIR
5-2 Autonova-Voseenko St.
Moscow,Russia
FEI #1000141779