Fraxel re:store DUAL Laser System MC-SYS-SR1500-D-USRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816995027010), received between May 22, 2024 and May 22, 2024 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED PROLONGED HEALING WITH AN INFECTION ON THE NECK 6 DAYS POST FRAXEL DUAL TREATMENT TO THE FACE AND NECK. THE REPORT NOTED THAT THE PATIENT HAD ANOTHER PROCEDURE (BOTOX) WITHIN THE LAST NINETY DAYS ON THE SAME AREA AS TREATMENT, BUT NOT ON THE SAME AREA AS THE EVENT. THIS WAS THE PATIENT'S FIRST FRAXEL PROCEDURE. THE PATIENT WAS PRESCRIBED AN UNKNOWN ANTIBIOTIC FOR THE INFECTION. THE CURRENT STATUS WAS OTHERWISE REPORTED TO BE NORMAL. THE OUTCOME WAS ALSO REPORTED THAT A PERMANENT SCAR IS UNLIKELY; HOWEVER, IT WAS NOTED AS UNCERTAIN AT THIS TIME. NO PICTURE WAS AVAILABLE TO REVIEW DESPITE MULTIPLE REQUESTS. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE THE SYMPTOMS OCCURRED. THE PATIENT WAS USING ASLKAN NECTAR AND MOISTURIZER- IT WAS UNSPECIFIED IF IT WAS USED BEFORE, DURING, OR AFTER THE TREATMENT. THE PATIENT HAD ¿SIGNIFICANT SUN DAMAGE¿ PRIOR TO THE TREATMENT AND THE SKIN TYPE RECORDED FOR THE PATIENT IS FITZPATRICK SKIN TYPE IV. THE HIGHEST ENERGY LEVEL USED WAS 10 MJ WITH 8 PASSES ON THE FACE AND NECK. THERE WERE OVERLAPPING PASSES. THERE WERE NO SYSTEM ERRORS THAT OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 19372845 ↗