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U.S. Department of Health and Human Services

Import Alert 86-09
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(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).

Import Alert # 86-09
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Excimer Lasers Manufactured For Export by Summit Technology"

Reason for Alert:
These devices were exported under Section 801(e)(2) prior to approval of the PMA and then introduced or delivered for introduction into U.S. interstate commerce for commercial distribution. These devices are not the same as those approved under the PMA.

Guidance:
Districts may detain without physical examination the excimer lasers of firms identified in the attachemnt for this alert if they are coming back into the U.S. for commercial distribution.

Product Description:
Ophthalmic Excimer Lasers (See attachment for specific models).

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device that was exported under Section 801(e)(2) prior to approval of an application for premarket approval (PMA) and then introduced or delivered for introduction into interstate commerce for commercial distribution and which differs from the approved device. [Adulteration, Section 501(f)(1)(B)]."

OASIS charge code - NO PMA

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


COSTA RICA
Lasersight Technologies Inclst Laser S.A.
Date Published : 09/16/2009

Zona Franca Metropolitana , Heredia, COSTA RICA
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:No models should be imported

GERMANY
Chiron Technolas Gmbh
Date Published : 09/16/2009

Max Planck-Str 6domach , Munchen, GERMANY
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:Keracor 116-versions mfgj'd for non-U.S. All Technolas Excimer Laser Systems for non-U.S.

IRELAND
Summit Technology Ireland B.V.
Date Published : 09/16/2009

Model Farm Road , Cork, IRELAND
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:Versions mfg'd for non-U.S. Apex Plus OmniMed Excimed Apex

JAPAN
Nidek Co., Ltd., Hamacho Plant
Date Published : 09/16/2009

67-4 Hama-cho , Gamagori -Shi, JAPAN
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:EC-5000 versions mfg'd for non-U.S. and All Excimer Laser Systems for non-U.S.

UNITED STATES
Alcon Refractive Horizons, Inc.
Date Published : 09/16/2009

2501 and 2800 Discovery Drive , Orlando, FL 32826-3010 UNITED STATES
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:LADARVision Scanning Laser

Summit Technology, Inc.
Date Published : 09/16/2009

21 Hickory Dr , Waltham, MA 02451-1011 UNITED STATES
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Desc:All units with serial # beginning with 2XXX.
Notes:Summit ExciMed Laser System;OmniMed Excimer Laser System and SVS Apex Laser Systems. S/N All units with serial # beginning with 2XXX. *Summit OmniMed Excimer Laser System,Summit SVS Apogee EX and SVS Apex Plus EX Laser Systems. *CONTACT CDRH FOR SPECIFIC SERIAL NUMBERS (MARY LOU DAVID) 301-594-4613.*

VISX INCORPORATED, A SUBSIDIARY OF AMO INC
Date Published : 09/16/2009

3400 Central Expy , Santa Clara, CA 95051-0703 UNITED STATES
86 L - - ZS Laser, System, Excimer
Date Published: 09/16/2009

Notes:VISX Excimer Laser System Models B&C for Phototherapeutic keratectomy (PTK), and Photorefractive Keratectomy (PRK); Star-2 version mfg'd for non-U.S.

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