Reported Apr 4, 2018 · Terminated
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical…
SIE AG, Surgical Instrument Engineering
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIE AG, Surgical Instrument Engineering · Allmendstrasse 11 · Port · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
125 of 125 codes
FLM4455FLM2313FLM4499FLM3230FLM2855FLM3097FLM4493FLM3178FLM4441FLM1592FLM2595FLM1225FLM4542FLM3771FLM1464FLM3999FLM2408FLM1995FLM4409FLM2185FLM2679FLM4987FLM3815FLM3904FLM1958FLM1179FLM2869FLM2584FLM4860FLM3766FLM2318FLM3406FLM4626FLM2324FLM1326FLM2053FLM2096FLM4222FLM4450FLM2266FLM4588FLM4175FLM4764FLM4902FLM4227FLM2457FLM1767FLM4132FLM4896FLM3007FLM1274FLM1009FLM1320FLM2537FLM3278FLM2508FLM3905FLM4043FLM4133FLM4314
- Serial Numbers
- Amount recalled
- 125 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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