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ACCLARENT INC

TruDi Navigation System · Ophthalmic

510(k): 0 Recall: 1 UDI: 0 MAUDE: 10 Class.: 66

Recalls (1)

2023-09-21

When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

MAUDE Adverse Events (10)

Malfunction
20251212
Malfunction
20251105
Malfunction
20251017
Malfunction
20250711
Malfunction
20250626
Malfunction
20250617
Malfunction
20250530
Malfunction
20250506
Malfunction
20250426
Malfunction

FDA Classification (66)

Clip, Iris Retractor

Ophthalmic

Dilator, Expansive Iris (Accessory)

Ophthalmic

Implant, Eye Valve

Ophthalmic

Hydrophilic Re-Coating Solution

Ophthalmic

Fixation, Vision Training, Binocular

Ophthalmic

Collagen Corneal Shield

Ophthalmic

Pupillometer, Manual

Ophthalmic

Aid, Vision, Electronic, Ac-Powered

Ophthalmic

Photostimulator, Ac-Powered

Ophthalmic

Tubing, Replacement, Phacofragmentation Unit

Ophthalmic

Device, Fixation, Ac-Powered, Ophthalmic

Ophthalmic

Corneal Inlay Inserter Handle

Ophthalmic

Vitrectomy, Instrument Cutter

Ophthalmic

Sterilizer, Tonometer

Ophthalmic

Camera, Ophthalmic, General-Use

Ophthalmic

Euthyscope, Ac-Powered

Ophthalmic

Projector, Ophthalmic

Ophthalmic

Instrument, Measuring, Stereopsis

Ophthalmic

Lens, Intraocular, Toric Optics

Ophthalmic

Drum, Opticokinetic

Ophthalmic

Expander, Tissue, Orbital

Ophthalmic

Ruler, Nearpoint (Punctometer)

Ophthalmic

Lens, Fundus, Hruby, Diagnostic

Ophthalmic

Lens, Contact, For Color Vision Deficiency

Ophthalmic

Retractor, Ophthalmic

Ophthalmic

Sunglasses (Non-Prescription Including Photosensitive)

Ophthalmic

Intraocular Lens

Ophthalmic

Applicator, Negative Pressure, External, Ocular

Ophthalmic

Tester, Color Vision

Ophthalmic

Keratome, Water Jet

Ophthalmic

Clip, Lens, Trial, Ophthalmic

Ophthalmic

Maxwell Spot, Ac-Powered

Ophthalmic

Cannula, Ophthalmic

Ophthalmic

Unit, Cryophthalmic

Ophthalmic

Topographer, Corneal, Ac-Powered

Ophthalmic

Stand, Instrument, Ophthalmic, Battery Powered

Ophthalmic

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Ophthalmic

Esthesiometer, Ocular

Ophthalmic

Burr, Corneal, Manual

Ophthalmic

Ocular Peg, Exempt

Ophthalmic

Lenses, Soft Contact, Daily Wear

Ophthalmic

System, Monitoring, For Progress Of Labor

Ophthalmic

Intranasal Electrostimulation Device

Ophthalmic

Lens, Contact (Other Material) - Daily

Ophthalmic

Retinoscope, Ac-Powered

Ophthalmic

Ophthalmoscope, Battery-Powered

Ophthalmic

Engine, Trephine, Accessories, Ac-Powered

Ophthalmic

Keratome, Ac-Powered

Ophthalmic

Aid, Vision, Optical, Battery-Powered

Ophthalmic

Photokeratoscope, Battery Powered

Ophthalmic

Eyelid Thermal Pulsation System

Ophthalmic

Screen, Tangent, Target, Battery-Powered

Ophthalmic

Marker, Ocular

Ophthalmic

Ophthalmoscopes, Replacement Batteries, Hand-Held

Ophthalmic

Light, Headband, Surgical

Ophthalmic

Prism, Fresnel, Ophthalmic

Ophthalmic

Device, Measuring, Lens Radius, Ophthalmic

Ophthalmic

Keratoprosthesis, Permanent Implant

Ophthalmic

Preamplifier, Ac-Powered, Ophthalmic

Ophthalmic

System, In-Office Tinting, Contact Lenses

Ophthalmic

Test, Spectacle Dissociation, Ac-Powered (Lancaster)

Ophthalmic

Sponge, Ophthalmic

Ophthalmic

Forceps, Ophthalmic

Ophthalmic

Weights, Eyelid, External

Ophthalmic

Table, Instrument, Powered, Ophthalmic

Ophthalmic

Engine, Trephine, Accessories, Battery-Powered

Ophthalmic