ClearanceBrief
Recall Z-1272-2018 ยท OOE Ophthalmic Femtosecond Laser

SIE AG, Surgical Instrument Engineering

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 treatme

DateJan 21, 2018
StatusTerminated
ReasonThis 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.
Root causeDevice Design
ActionThe 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 traini
Quantity125 devices
DistributionWorldwide 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, Ro
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K150323FEMTO LDV Z8 Surgical Laser
Sie Ag,Surgical Instrument Engineering, Oct 23, 2015