IA #86-09, Revision 7/8/96 - "DETENTION WITHOUT PHYSICAL EXAMINATION OF EXCIMER
LASERS MANUFACTURED FOR EXPORT", Attachment 12/3/01
**NOTE: In order to make this alert applicable to multiple manufacturers,
the alert's title and problem sections have been revised removing
references to Summit Technology. Changes appear between ***
TYPE OF
ALERT: Detention without Physical Examination
NOTE: This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s)and/or product(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: Ophthalmic Excimer Lasers (See attachment for specific models).
PRODUCT
CODE: 86LZS
PROBLEM: FDA/CDRH has received information which indicates that ophthalmic
excimer lasers manufactured for export under Section 801(e)(2) are
being imported into the United States for the purpose of commercial
distribution. These Class III products were manufactured prior to
PMA approval *** and do not meet PMA specifications.***
The software and specifications for these devices differ from the
devices under the approved PMAs. The software and specification
differences however, are not discernable from an outside inspection
of the device. Most of the exported devices also do not contain a
counting device used to monitor the number of procedures, and the
labeling on the exported devices differs from that of the approved
devices. These previously exported devices are considered to be
adulterated under the Act if they are sold or offered for sale in
domestic commerce.
PAF: AAP
PAC: 82007
COUNTRY: All
MANUFACTURER/
SHIPPER: See attachment
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)].
RECOMMENDING
OFFICE: CDRH, DOE II, HFZ-330
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
listed in the attachment if they are coming back into the U.S. for
commercial distribution.
FOI: No purging required.
KEYWORDS: Excimer, PMA, Export, Laser, Premarket Approval
PREPARED
BY: Stella Notzon, DIOP, 301-443-6553.
DATE LOADED
INTO FIARS: November 3, 2001
Attachment: List of firms/products subject to detention without physical
examination-5/31/01
MANUFACTURER Importer Models/SN
Autonomous Technologies LADARVision
2800 Discovery Drive Scanning Laser
Orlando, FL 32826 11/4/99
FEI # 3000209733
Chiron Technolas GmbH Keracor 116-versions
Max-Planck-Strasse 6 mfg'd for non-U.S.
D-85609 Dornach 11/4/99
Munich, Germany All Technolas
FEI # 1000586119 Excimer Laser
Systems for non-
U.S.
LaserSight Technologies No models should
Metro Free Zone be imported
Barreal de Heredia 11/4/99
Costa Rica
FEI # 1000661163
Nidek (Hiroishi Plant) EC-5000 versions
34-14 Meanhama Hiroishi-Cho mfg'd for non-U.S.
Gamagori Aichi 433 11/4/99
Japan
FEI #3002839202 and All Excimer
Laser Systems for
non-U.S.
5/31/01
Summit Technology Hi-Line Medical Summit ExciMed
21 Hickory Drive Laguna Hills, CA Laser System,
Waltham, MA 02154 OmniMed Excimer
FEI #1287364 Laser System &
SVS Apex Laser
Systems.
S/N: All units with
serial # beginning
with 2XXX.
Summit Technology Unknown *Summit OmniMed
21 Hickory Drive Excimer Laser
Waltham, MA 02154 System, Summit
FEI #1287364 SVS Apogee EX & SVS
Apex Plus EX Laser
Systems
*CONTACT CDRH FOR SPECIFIC SERIAL NUMBERS (MARY LOU DAVIS, 301-594-4613).*
Summit Technology Ireland B.V. Versions mfg'd for
Cork Business and Technology Park non-U.S.
Model Farm Road Apex Plus
Cork, Ireland OmniMed
FEI # 1000272072 Excimed
Apex
11/4/99
VISX, Inc. Unknown VISX Excimer Laser
3400 Central Expressway System Models B&C
Santa Clara, CA 95051-0703 for Phototherapeutic
FEI # 3000245144 keratectomy (PTK) &
Photorefractive
Keratectomy (PRK)
Star-2 version mfg'd for
non-U.S.
11/4/99
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