ILIGHT IPL6500
Received Jun 26, 2019 · Event occurred Apr 15, 2019
Report 3005855240-2019-00001 · MDR key 8737821
Device
Product problems
- Use of Device Problem
- Insufficient Device Problem Information
- Use of Device Problem
- Insufficient Device Problem Information
Patient
21 YR
- Eye Injury
- Retinal Injury
- Eye Injury
- Retinal Injury
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS NOT RETURNED SO WE WERE UNABLE TO CONDUCT AN INVESTIGATION OF IT. HOWEVER, THE DHR OF THE DEVICE FROM THE SUPPLIER SHOWED THAT ALL ITEMS MET THE DESIGN SPECIFICATIONS WHEN SHIPPED FROM THE MANUFACTURER. MOREOVER: THE IPL6500 DEVICE IS DESIGNED AND MANUFACTURED WITH A SPECIFIC CAP MEANT TO BE USED ON THE FEMALE FACE BELOW THE CHEEKBONE. THIS FACIAL ATTACHMENT WAS DESIGNED WITH NO VENT HOLES TO MINIMIZE THE LIGHT LEAKAGE WHEN OPERATING BELOW THE CHEEKBONE. IN ADDITION, THE DEVICE HAS SKIN CONTACT SENSORS THAT PREVENT ACCIDENTAL FLASHING. THE DEVICE WILL NOT FLASH UNLESS BOTH OF THE SKIN CONTACT SENSORS ARE IN FULL CONTACT WITH THE SKIN. THE INSTRUCTIONS FOR USE OF THE DEVICE SHOW AND WARN THE USER MULTIPLE TIMES HOW TO PROPERLY USE THE FACIAL ATTACHMENT. THIS IS COVERED IN THE SKIN CHART SECTION, THE WARNINGS AND SAFETY SECTION, THE TREATMENT SECTION, AND THE FAQ SECTION. THE INSTRUCTIONS FOR USE SPECIFICALLY WARN THAT USING THE DEVICE ON OR AROUND THE EYES, EYEBROWS, OR EYELASHES CAN CAUSE SERIOUS AND PERMANENT EYE INJURY. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT SPECTRUM BRANDS, INC. OWNER OF SHASER,INC HAS RECEIVED IN THE 5 YEARS WE HAVE SOLD THE DEVICE. SPECTRUM BRANDS, INC. OWNER OF SHASER, INC. RECEIVED THIS COMPLAINT FROM A PREVIOUSLY UNKNOWN END-USER LOCATED IN (B)(6). NEITHER SPECTRUM NOR SHASER SELL THIS DEVICE IN (B)(6) AND CURRENTLY SUSPECT THAT THIS ACTIVITY MAY HAVE OCCURRED THROUGH AN UNAUTHORIZED THIRD-PARTY DISTRIBUTION CHANNEL OR A COUNTERFEITER. SPECTRUM FILED INITIAL VOLUNTARY SELF-DISCLOSURE NOTICES REGARDING THIS ISSUE WITH THE U.S. TREASURY DEPARTMENT¿S OFFICE OF FOREIGN ASSETS CONTROL (OFAC) AND U.S. COMMERCE DEPARTMENT¿S BUREAU OF INDUSTRY & SECURITY (BIS) ON JUNE 20, 2019 AND WILL PROVIDE COMPLETE REPORTS TO THOSE AGENCIES REGARDING POTENTIAL ECONOMIC SANCTIONS OR EXPORT CONTROL CONCERNS WITHIN 60 DAYS.
Description of Event or Problem
THE END USER REPORTED USING THE IPL6500 AND THE DEVICE CAUSED AN INJURY TO HER EYES.