Pharos EX-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842362100017), received between Aug 21, 2019 and Mar 3, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K062963); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TREATMENT FOR A DERMATOLOGICAL CONDITION ON THE LEGS AND ARMS, THE PATIENT EXPERIENCED UNEXPECTED ERYTHEMA WITH BLISTERING AND WEEPING. HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT IS HEALING WELL. USER FACILITY PROTOCOL TO TREAT ERYTHEMA IS TO APPLY A THIN LAYER OF HYTON WITH AQUAPHOR TWICE DAILY, IN ADDITION TO DECREASING THE DOSE BY 100-200 MJ/CM2 AND NOT TREATING EFFECTED AREAS UNTIL FULLY HEALED. HEALTHCARE PROFESSIONAL STATED THAT PATIENT HAS A HISTORY OF ERYTHEMA AFTER TREATMENT. THE DOSE DELIVERED AT TIME OF EVENT WAS 500 MJ/CM2. THE DOSE DELIVERED AT THE PREVIOUS TREATMENT WAS 400 MJ/CM2. REPORTEDLY, THE PATIENT HAD NOT APPLIED ANY TOPICALS OR PHOTOSENSITIZING AGENTS PRIOR TO TREATMENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Erythema

  MAUDE report 11407680 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TREATMENT FOR A DERMATOLOGICAL CONDITION ON BOTH LEGS, THE PATIENT EXPERIENCED UNEXPECTED ERYTHEMA WITH BLISTERING ON THE LEFT LEG. HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT IS HEALING WELL. USER FACILITY PROTOCOL TO TREAT ERYTHEMA IS TO APPLY A THIN LAYER OF HYTON WITH AQUAPHOR TWICE DAILY, IN ADDITION TO DECREASING THE DOSE BY 100-200 MJ/CM2 AND NOT TREATING EFFECTED AREAS UNTIL FULLY HEALED. HEALTHCARE PROFESSIONAL STATED THAT PATIENT HAS A HISTORY OF ERYTHEMA AFTER TREATMENT. THE DOSE DELIVERED TO THE LEFT LEG AT TIME OF EVENT WAS 850 MJ/CM2. THE DOSE DELIVERED TO THE LEFT LEG AT THE PREVIOUS TREATMENT WAS 850 MJ/CM2. REPORTEDLY, THE PATIENT HAD NOT APPLIED ANY TOPICALS OR PHOTOSENSITIZING AGENTS PRIOR TO TREATMENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

  Patient problems: Erythema

  MAUDE report 11407646 ↗
• MalfunctionAug 21, 2019Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT A DEVICE MALFUNCTIONED ON (B)(6) 2019. THIS WAS FOLLOWED BY A REPORT ON (B)(6) 2019 OF A PATIENT EXPERIENCING ERYTHEMA AFTER TREATMENT WITH THE EX-308.

  Patient problems: Erythema

  MAUDE report 8916413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062963. One submission often covers many models, so check the product and lot details in each record.

• Z-1631-2020 · Aug 23, 2019 · Terminated
  Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leuk
• Z-2123-2014 · Jun 30, 2014 · Terminated
  PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma