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U.S. Department of Health and Human Services

Class 2 Device Recall 1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6

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  Class 2 Device Recall 1) FEMTO LDV Z2, 2) FEMTO LDV Z4, 3) FEMTO LDV Z6 see related information
Date Initiated by Firm April 16, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on December 27, 2017
Recall Number Z-0811-2014
Recall Event ID 64966
510(K)Number K112154  
Product Classification Laser, ophthalmic - Product Code HQF
Product 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface.

2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea.

3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
Code Information Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817
Recalling Firm/
Manufacturer
Ziemer Usa Inc
620 East Third Street
Alton IL 62002
For Additional Information Contact Ms. Angela Braida
618-462-9301
Manufacturer Reason
for Recall
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
FDA Determined
Cause 2
Component design/selection
Action A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue.
Quantity in Commerce 5 units
Distribution Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
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 = SIE AG,SURGICAL INSTUMENT ENGINEERING
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