HLMClass I

Instrument, Measuring, Lens, Ac-powered

Ophthalmic · 21 CFR 886.1425

MDR events5All time

Recalls1All time

Registered firms66Currently listed

510(k) clearances16All time

Recent MDR events

5 adverse event reports on file

NOKIA LUMIA 1020 (GOCHECK KIDS MOBILE APP INSTALLED) PRODUCT CODE INCORRECT N/ASep 12, 2018
MalfunctionOriginal Manufacturer Nokia Out Of Business3010539401-2018-00001
LUXOR Q-VUEJul 16, 2013
MalfunctionAlcon - Irvine Technology Center2028159-2013-01386
LUXOR Q-VUEJul 16, 2013
MalfunctionAlcon - Irvine Technology Center2028159-2013-01391
ACCURUS 400 VSJun 8, 2012
MalfunctionAlcon - Irvine Technology Center2028159-2012-00838
IOLMASTERMay 4, 2010
MalfunctionCarl Zeiss1717016

Event type breakdown

Malfunction5

Most-reported manufacturers

Alcon - Irvine Technology Center3 Carl Zeiss1 Original Manufacturer Nokia Out Of Business1

Recalls

1 recall events for this product code

Carl Zeiss Meditec AG
TerminatedUnknown
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displ
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
Z-0613-2021 · View FDA record ↗

Registered firms

66 firms currently registered for this product code

510(k) clearances

16 clearances for this product code