The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The recall
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…
Why was The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- SIE AG, Surgical Instrument Engineering
- Quantity
- 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.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)