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.
Recall
- Recall Number
- Z-1272-2018
- Event Number
- 79379
- Firm
- SIE AG, Surgical Instrument Engineering Allmendstrasse
- FEI Number
- 3005643720
- Product Code
- OOE
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- January 21, 2018
- Terminated
- November 2, 2018
- Address
- 11 Port Switzerland
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.
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.
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.
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.
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