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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed eye Safety filters

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  Class 2 Device Recall Fixed eye Safety filters see related information
Date Initiated by Firm February 01, 2016
Create Date April 07, 2016
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-1270-2016
Recall Event ID 73468
510(K)Number K052777  
Product Classification Laser, ophthalmic - Product Code HQF
Product Ellex Medical Fixed eye Safety filters Model Integre S LP5532.

The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible.


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Code Information Model Number : 3143270
Recalling Firm/
Manufacturer		 Laserex Systems Inc.
7138 SHADY OAK RD
EDEN PRAIRIE MN 55344-3517
For Additional Information Contact
800-824-7444
Manufacturer Reason
for Recall		 The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
FDA Determined
Cause 2		 Device Design
Action Ellex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (800) 824-7444.
Quantity in Commerce 72 units plus 2 spare units
Distribution Worldwide Distribution - US Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = Ellex Medical Pty. Ltd.
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