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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- Hazard
- Affected units
- 125
Distribution
Related recalls
Same hazard · usability defect
See all →- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- ModerateTerumo Advanced Perfusion System 1 Gas System Recall
FDA (Devices) · 2012-07-18
Other medical device recalls
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZiemer FEMTO LDV Z2, Z4, and Z6 Lasers Recalled for Monitor Overheating
FDA (Devices) · 2014-01-29
- ModerateZiemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits
FDA (Devices) · 2015-01-21
- HighAlcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect
FDA (Devices) · 2014-04-16
- HighAlcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation
FDA (Devices) · 2016-05-25
- ModerateAbbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
FDA (Devices) · 2016-09-28
- HighAbbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk
FDA (Devices) · 2015-04-29