MAUDE Adverse Event Report: LYMA LIFE LTD. LYMA LASER; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Health Effect - Clinical Codes	Erythema (1840); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Eye Burn (2523)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I began use of the fda-approved lyma laser (for cosmetic decrease of wrinkles).It's marketed as completely safe, thoroughly tested, and having no side effects.On the first day of use on my face, i experienced redness and pain on my right cheekbone and i had a mild headache and watery eyes.The company has a "concierge" one can write to with problems.I wrote, and was told the lyma could not have caused the problem and is completely safe.She suggested changing the moisturizer i used, as it might have been an allergic reaction.I did that and continued use, avoiding what turned out to be the burn on my cheekbone.Each day the headache worsened and both eyes watered and were very painful, with the pain continuing longer each day.The concierge again told me it was impossible for the lyma laser to be the cause.On day 4, i sustained another burn on my left cheekbone, and the headaches and eye pain became extreme and constant.I discontinued use and reported the side effects to the concierge.Once again, she dismissed my side effects.However, the company agreed to give me a refund, even though it's against their policy.The headaches and eye pain were almost unbearable at this point.I saw my doctor, who diagnosed the two burns on my cheekbones and said i likely had corneal nerve damage, similar to a side effect of lasik eye surgery.The pain has started to decrease somewhat after 3 weeks, and with the use of a prescription eye ointment from my doctor.We are monitoring the situation.I want it on the record that the company that makes lyma tells consumers to continue using it, even when they experience burns and pain.If their clinical trials have not indicated any side effects, they have not tested it sufficiently.They continue to advertise it as completely safe for all users.

• Brand Name: LYMA LASER
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): LYMA LIFE LTD.
• MDR Report Key: 18365370
• Report Number: MW5149399
• Device Sequence Number: 19499023
• Product Code: OHS
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/15/2023

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White