MAUDE Adverse Event Report: LUMENIS LTD YOKNEAM ISRAEL / LUMENIS, INC. M22 IPL; POWERED LASER SURGICAL INSTRUMENT

Model Number M22

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Scar (1793); Burning Sensation (2146)

Event Date 10/12/2018

Event Type  Injury  

Event Description

My physician has used an m22 ipl made by lumenis for my dry eye treatment, burning my right eyelid.I have a scar now, after a strong burn sensation.I discovered tht the m22 laser and ipl device is not cleared by fda for dry eye treatments.It is a shame that the product is promoted for this use.Please let me know if i can contact the fda legal office to claim damages against my physician and company lumenis.(b)(6).

• Brand Name: M22 IPL
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD YOKNEAM ISRAEL / LUMENIS, INC. ; 2033 gateway place; ste 200; san jose CA 95110
• MDR Report Key: 7973424
• MDR Text Key: 124114854
• Report Number: MW5080589
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: M22
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR