The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an…
Medical device recall Z-1272-2018. Published in FDA’s Enforcement Report on Apr 4, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 4, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 12 states named
- 125 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
125 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,015 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Alabama
- California
- Florida
- Georgia
- Illinois
- Indiana
- Minnesota
- Oregon
- Tennessee
- Texas
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 21, 2018.
- FDA classified it on Mar 29, 2018.
- FDA’s Enforcement Report published it on Apr 4, 2018.
- FDA terminated it on Nov 2, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SIE AG, Surgical Instrument Engineering, of Port, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.