DeviceClearance

Product code HQL— Ophthalmic

AMER. MEDICAL OPTICS DIGITAL KERATO-

Classification name
Intraocular Lens
Device class
Class 3
Regulation
21 CFR 886.3600
Advisory panel
Ophthalmic
Total cleared
5
First cleared
Most recent

Market context for product code HQL

FDA has cleared 5 devices under product code HQL between 1978 and 1992, filed by 5 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

Top applicants under product code HQL

Adverse events under product code HQL

product code HQL
Injury
7,145
Malfunction
15,684
Other
5
Total
22,834

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 HQL

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