UltraQ Reflex LQP3106-U (UDI 09342395000427)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09342395000427), received between Mar 7, 2018 and Dec 14, 2023 — classified as 7 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX LASER WHERE THE PATIENT DEVELOPED FULL THICKNESS MACULAR HOLE IN LEFTEYE, IMMEDIATELY AFTER THE THIRD LASER PULSE.THIS REPORT IS MADE BY LUMIBIRD MEDICAL INC WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Vitreous Hemorrhage

  MAUDE report 18332083 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX LASER WHERE THE DOCTOR REPORTED TO HAVE HIT A BLOOD VESSEL AND FELT THE SYSTEM WAS UNSAFE FOR USE. THIS REPORT IS MADE BY LUMIBIRD MEDICAL INC WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18332036 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX LASER WHERE THE PATIENT DEVELOPED FULL THICKNESS MACULAR HOLE IN LEFT EYE, IMMEDIATELY AFTER THE THIRD LASER PULSE. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Vitreous Hemorrhage

  MAUDE report 18279406 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX LASER WHERE THE DOCTOR REPORTED TO HAVE HIT A BLOOD VESSEL AND FELT THE SYSTEM WAS UNSAFE FOR USE. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18188540 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELLEX SERVICES EUROPE RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE SURGEON PERFORMED A FLOATER TREATMENT ON A PHAKIC PATIENT WITHOUT COAXIAL ILLUMINATION, WHICH LED HIM TO SHOOT THE CRYSTALLINE LENS CAUSING AN IMMEDIATE TRAUMATIC CATARACT. THE EVENT OCCURRED IN (B)(6) 2019 HOWEVER WAS COMMUNICATED TO THE ELLEX SERVICE TECH DURING THE SUBSEQUENT SERVICE CALL ON 4THMAY'2020. THE PATIENT HAD BEEN ADVISED FOR CATARACT SURGERY. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Eye Injury

  MAUDE report 10099860 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INADVERTENTLY HIT A PATIENT'S RETINA IN THE LEFT EYE WITH THE YAG LASER AND IT CREATED A SMALL CONTUSION NOTED BY A WHITE MARK AND THIS CAUSED A MODERATE BLEED INTO THE VITREOUS WHICH REDUCED THE PATIENT'S VISUAL ACUITY.

  Patient problems: Retinal Injury

  MAUDE report 8480547 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT OCCURED IN USA, (B)(6). DURING TREATMENT FOR POSTERIOR MEMBRANECTOMY, THE DOCTOR HIT THE PATIENT'S RETINA , CAUSING A SMALL CONTUSION. POSSIBLE USER ERROR.

  Patient problems: Retinal Injury

  MAUDE report 7322433 ↗