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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 I

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
HNR	Forceps, Ophthalmic	1	0	13
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	1	0	3
HNQ	Hook, Ophthalmic	1	0	2
HKO	Refractometer, Ophthalmic	1	0	1
HMQ	Marker, Sclera	1	0	1
HNN	Knife, Ophthalmic	1	0	1
MSS	Folders And Injectors, Intraocular Lens (Iol)	1	1	0