Import Alert 86-09

Import Alert # 86-09

Published Date: 11/22/2022

Type: DWPE

"Detention Without Physical Examination Of Excimer Lasers Manufactured For Export"

Note: The revision of this Import Alert (IA) dated 11/22/2022 updates the name of the alert, subtype to firm alert, reason for alert and guidance sections including agency contacts, charge code language, PAF, PAC. Changes to the import alert are bracketed by asterisks (***).

***These Excimer lasers laser systems are for the correction of refractive error by reshaping the surface of the cornea. The high-energy ultraviolet (UV) light is from pulsed gas (e.g., argon-fluoride) excimer laser system. The wavelength for argon-fluoride excimer lasers used for refractive surgery is 193 nm. The UV energy from the excimer laser disrupts the chemical bonds in the cornea without causing any thermal damage to surrounding tissue.

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.

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.***

***Divisions may detain, without physical examination, shipments of the products identified on the Red List of this alert if they are coming back into the U.S. for commercial distribution.

Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO) and FDA's Center for Devices and Radiological Health (CDRH) will evaluate regulatory packages on a case-by-case basis.

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions concerning these types of products or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov

                                                                                                                                                                         ***

***Ophthalmic Excimer Lasers***

*** 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 and does not appear to have in effect an approved application for
premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1). [Adulteration, Section 501(f)(1)(B)] ***

OASIS charge code - NO PMA

Notes: No models should be imported

Desc: Laser; System; Excimer

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

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

Desc: Laser; System; Excimer

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

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

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

Notes: LADARVision Scanning Laser

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.*

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.