The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Lase...
FDA Device Recall #Z-1272-2018 - Class II, January 21, 2018
Recall Summary
| Recall Number | Z-1272-2018 |
| Classification | Class II - Moderate risk |
| Date Initiated | January 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SIE AG, Surgical Instrument Engineering |
| Location | Port |
| Product Type | Devices |
| Quantity | 125 devices |
Product Description
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.
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.
Distribution Pattern
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.
Lot / 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
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.