FDAJanuary 21, 2018device
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 fo...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV...2026-04-24
- FDASharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife2026-04-23
- FDADa Vinci ASSY, PSS, SP1098, Part Number: 3806012026-04-22
- FDAProduct Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantati...2026-04-20
- FDABrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Pat...2026-04-02
- FDADEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-232026-03-25
- FDADEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-252026-03-25
- FDADEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S2026-03-25
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