HLFClass I

Device, Measuring, Lens Radius, Ophthalmic

Ophthalmic · 21 CFR 886.1430

MDR events0All time

Recalls1All time

Registered firms26Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Haag-Streit USA Inc
TerminatedJun 24, 2010
Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland.
During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in
Z-1897-2010 · View FDA record ↗

Registered firms

26 firms currently registered for this product code

510(k) clearances

3 clearances for this product code