MAUDE Adverse Event Report: SHASER INC ILIGHT IPL6500

Model Number IPL6500

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Eye Injury (1845); Retinal Injury (2048)

Event Date 04/15/2019

Event Type  Injury  

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.

Event Description

The end user reported using the ipl6500 and the device caused an injury to her eyes.

• Brand Name: ILIGHT IPL6500
• Type of Device: IPL6500
• Manufacturer (Section D): SHASER INC; 3001 deming way; middleton WI 53562
• Manufacturer (Section G): SHASER INC
• Manufacturer Contact: lavee yang ; 3001 deming way; middleton, WI 53562 ; 6082786362
• MDR Report Key: 8737821
• MDR Text Key: 149336484
• Report Number: 3005855240-2019-00001
• Device Sequence Number: 1
• Product Code: ONF
• Combination Product (y/n): Y
• Reporter Country Code: IR
• PMA/PMN Number: K120080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IPL6500
• Device Catalogue Number: IPL6500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2019
• Event Location: Home
• Date Report to Manufacturer: 06/26/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR