DeviceClearance

Product code KYB— Ophthalmic

MONARCH IOL DELIVERY SYSTEM

Classification name
Lens, Guide, Intraocular
Device class
Class 1
Regulation
21 CFR 886.4300
Advisory panel
Ophthalmic
Total cleared
39
First cleared
Most recent

Market context for product code KYB

FDA has cleared 39 devices under product code KYB between 1979 and 2015, filed by 27 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KYB

Adverse events under product code KYB

product code KYB
Injury
218
Malfunction
1,989
Other
1
Total
2,208

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KYB

Data sourced from openFDA. This site is unofficial and independent of the FDA.