Panels › Ophthalmic

Ophthalmic devices

243 product codes reviewed by the Ophthalmic panel. 4,761 510(k) clearances and 972 recalls in the FDA data, 38% of those recalls name a 510(k).

41510(k)s in 12 months

54recalls in 12 months

370recalls that name a 510(k)

Active product codes, Class II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
OJK	Eye Tray	2	0	17
LPL	Lenses, Soft Contact, Daily Wear	2	12	1
HQB	Photocoagulator And Accessories	2	0	4
HQC	Unit, Phacofragmentation	2	4	0
OBO	Tomography, Optical Coherence	2	3	1
HKI	Camera, Ophthalmic, Ac-Powered	2	3	0
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	2	0	3
HQF	Laser, Ophthalmic	2	2	1
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	2	2	0
MVN	Lens, Contact, (Disposable)	2	1	1
MXK	Device, Analysis, Anterior Segment	2	2	0
MYC	Ophthalmoscope, Laser, Scanning	2	2	0
ORZ	Eyelid Thermal Pulsation System	2	2	0
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	2	0	1
HJM	Transilluminator, Ac-Powered	2	0	1
HLZ	Electrode, Corneal	2	1	0
HQD	Lens, Contact (Other Material) - Daily	2	1	0
LPN	Accessories, Soft Lens Products	2	1	0
LRX	Case, Contact Lens	2	1	0
MLP	Keratoprosthesis, Temporary Implant, Surgical Use	2	1	0
PIB	Diabetic Retinopathy Detection Device	2	1	0
QQJ	Applicator, Negative Pressure, External, Ocular	2	1	0