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U.S. Department of Health and Human Services

Class 2 Device Recall The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser

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  Class 2 Device Recall The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser see related information
Date Initiated by Firm January 21, 2018
Create Date March 29, 2018
Recall Status1 Terminated 3 on November 02, 2018
Recall Number Z-1272-2018
Recall Event ID 79379
510(K)Number K150323  
Product Classification Ophthalmic femtosecond laser - Product Code OOE
Product The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser

The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Code Information Serial Numbers:  FLM4455 FLM2313 FLM4499 FLM3230 FLM2855 FLM3097 FLM4493 FLM3178 FLM4441 FLM1592 FLM2595 FLM1225 FLM4542 FLM3771 FLM1464 FLM3999 FLM2408 FLM1995 FLM4409 FLM2185 FLM2679 FLM4987 FLM3815 FLM3904 FLM1958 FLM1179 FLM2869 FLM2584 FLM4860 FLM3766 FLM2318 FLM3406 FLM4626 FLM2324 FLM1326 FLM2053 FLM2096 FLM4222 FLM4450 FLM2266 FLM4588 FLM4175 FLM4764 FLM4902 FLM4227 FLM2457 FLM1767 FLM4132 FLM4896 FLM3007 FLM1274 FLM1009 FLM1320 FLM2537 FLM3278 FLM2508 FLM3905 FLM4043 FLM4133 FLM4314 FLM1819 FLM2186 FLM3135 FLM2627 FLM4271 FLM1092 FLM4759 FLM1724 FLM2589 FLM4770 FLM2038 FLM1188 FLM1640 FLM1915 FLM4317 FLM1814 FLM2812 FLM1003 FLM4859 FLM1135 FLM4807 FLM1502 FLM3183 FLM1182 FLM4954 FLM4000 FLM4531 FLM2551 FLM1554 FLM3539 FLM1046 FLM2765 FLM4897 FLM2913 FLM1093 FLM4632 FLM1686 FLM2912 FLM1782 FLM1545 FLM3359 FLM4908 FLM2085 FLM1407 FLM1863 FLM4308 FLM3677 FLM2636 FLM1008 FLM4361 FLM4669 FLM4498 FLM3729 FLM1773 FLM1364 FLM1591 FLM1824 FLM2229 FLM2450 FLM2722 FLM3676 FLM3861 FLM4593 FLM3040 FLM2001 
Recalling Firm/
Manufacturer		 SIE AG, Surgical Instrument Engineering
Allmendstrasse 11
Port Switzerland
Manufacturer Reason
for Recall		 This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
FDA Determined
Cause 2		 Device Design
Action The firm, Ziemer Ophthalmology, initiated their field correction by telephone on 01/21/2018 and followed with a letter on 01/28/2018. The letter described the product, problem and actions taken. The letter stated: "...we will be releasing new software which contains an added safety feature which will prevent unintended shift of the planned ARC Incisions and/or alert you in case of unforeseen eye movement between configuration and execution of the ARC incisions. We will be contacting your practice the week of March 12th to set up a time to install this new software and provide in-depth training. Prior to the installation of the new software, you may continue to use the Z8 for cataract surgery; however, we would advise that you not perform both arcuate and clear corneal incisions on the same patient until the new software is installed. If you have any questions, do not hesitate to contact Director of Operations at 618-462-9301 for any further information you require.
Quantity in Commerce 125 devices
Distribution Worldwide Distribution: US (nationwide) including states of: AL, CA, FL, GA, IL, IN, MN, OR, TN, TX, VA, and WA; and countries of: Argentina, Austria, Belgium, Brazil, Canada, France, Germany, India, Iraq, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Namibia, Pakistan, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, South Africa, Switzerland, Taiwan, and United Arab Emirates.
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 = OOE and Original Applicant = SIE AG,Surgical Instrument Engineering
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