MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING COMPANY BRAUN IPL HAIR REMOVAL FOR WOMEN AND MEN, NEW SILK EXPERT PRO 5; LIGHT BASED OVER-THE-COUNTER HAIR REMOVA

Catalog Number	PL5157
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I used the brain ipl hair removal for women and men, new silk expert pro 5 pl5157, for the first time on my face.My hand slipped and the laser fired in my eyes.At first i thought nothing of it but that night when it was dark out, i lost vision with the dark black ring which was blurry on the inside and peripherally around the ring.I had complete vision cuts where the black circle was.When i closed my eyes, i would see a white ring.It took about 15-20 minutes the first night to correct.The next night, same exact thing happened.It took about 10 minutes to correct.Went to the eye doctor on the (b)(6).He felt it was temporary.The symptoms seemed to have resolved.However, i was at the beach on (b)(6), in the sun.The black ring came back at night but only for a couple of minutes.Again last night, (b)(6), after using my lighted mirror, i had bright rings moving around the room after used the mirror and turning off the light.I'm headed back to the eye doctor for a second examination.Braun has repeatedly said this is safe and no need to wear goggles to protect your eyes on the information packet and in faq on amazon's website.I have since returned the item to the seller.

• Brand Name: BRAUN IPL HAIR REMOVAL FOR WOMEN AND MEN, NEW SILK EXPERT PRO 5
• Common Device Name: LIGHT BASED OVER-THE-COUNTER HAIR REMOVA
• Manufacturer (Section D): PROCTER & GAMBLE MANUFACTURING COMPANY
• MDR Report Key: 17079436
• Report Number: MW5118219
• Device Sequence Number: 6484764
• Product Code: OHT
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PL5157
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHLOBETOSOL PRN; CLARITIN PRN; IBUPROFEN PRN ; PROVENTALIN PRN
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White