PHILIPS LUMEA COMFORT
Received May 5, 2016 · Event occurred Mar 21, 2016
Report 3009226815-2016-00003 · MDR key 5634002
Device
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- Eye Injury
- Eye Injury
Narrative
Additional Manufacturer Narrative
THIS IS THE FIRST TIME THIS TYPE OF COMPLAINT HAS BEEN RECEIVED. IT IS NOT KNOWN IF THE CONSUMER HAD A PRE-EXISTING CONDITION THAT WOULD HAVE CAUSED THE DIAGNOSIS. THE UNIT HAS BEEN REQUESTED BACK FROM THE CONSUMER FOR INVESTIGATION AND ANALYSIS. WITHOUT AN INVESTIGATION OF THE ACTUAL UNIT, WE ARE UNABLE TO CONFIRM THE COMPLAINT.
Description of Event or Problem
CONSUMER CLAIMS THAT WHEN USING THE DEVICE OVER HER CALF SHE PRESSED THE BUTTON FOR A FLASH, BUT THE FLASH DID NOT COME ON INSTANTLY. SHE HAD TIME TO PULL THE DEVICE AND JUST AT THAT TIME THE FLASH OCCURRED. SHE WAS LOOKING DIRECTLY INTO THE LIGHT AND SAW WHITE MARKS IN HER SIGHT FOR A FEW HOURS.