SIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers
SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states the complication was due to user error and the recall is for usability improvements, fitting the 'voluntary precautionary' or 'low-risk' criteria for a Moderate score.
Plain-English summary
SIE AG, Surgical Instrument Engineering, is recalling 125 units of the FEMTO LDV Z8 Femtosecond Surgical Laser. This ophthalmic surgical laser is intended for use in creating corneal incisions for LASIK surgery, tunnel creation for ring implantation, and various procedures for cataract surgery, including capsulotomy and phacofragmentation.
The recall was initiated following a customer complaint received on November 16, 2017, which reported a complication during a cataract procedure. An investigation by the manufacturer determined that while the specific complication was due to user error, improvements could and should be made to the device to enhance its usability and performance.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare providers and facilities with these devices should contact SIE AG for further instructions on the corrective action.
The recalled product
- 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 creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rin
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- Hazard
- Affected units
- 125
Distribution
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