inforMED
MalfunctionOND

TEARLAB OSMOLARITY SYSTEM

Received Nov 14, 2015 · Event occurred Nov 13, 2015

Report MW5057943 · MDR key 5235240

Device

Generic name

Tearlab Osmolarity System

Manufacturer

Tearlab Inc.

Lot number

A1039486

Product problems

  • Labelling, Instructions for Use or Training Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PACKAGE INSERT CANNOT BE READ - TYPE IS TOO SMALL FOR EVEN A MAGNIFYING GLASS - WILL LEAD TO MISUSE. DATES OF USE: (B)(6) 2015. REASON FOR USE: DRY EYE.