Quest™ EC-5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987669100028), received between Apr 28, 2016 and Aug 30, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (2 reports).

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.

• InjuryAug 30, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON AUGUST 9, 2019 CUSTOMER CONTACTED NIDEK INC. SALES MANAGER TO DISCUSS A POSSIBLE OVERCORRECTION AFTER SURGERY WITH EC-5000 S/N (B)(4). HE INFORMED THAT THE PATIENT WAS NOT HAPPY WITH THE RESULT ON LEFT EYE. SALES MANAGER RECOMMENDED THE DOCTOR TO ALWAYS DOUBLE CHECK THE CALIBRATION RESULTS PRIOR TO TREATMENT AND SUBSEQUENTLY CONTACTED NIDEK INC. FIELD SERVICE REP TO PERFORM INSPECTION TO ENSURE THE ENERGY OUTPUT FROM THE LASER SYSTEM WAS APPROPRIATE. NIDEK INC. SERVICE MANAGER BECAME AWARE OF THE ISSUE ON AUGUST 12, 2019. THE CUSTOMER INFORMED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2019 AND THE OVERCORRECTION ISSUE WAS IDENTIFIED BY THE DOCTOR THE FOLLOWING DAY. THERE WERE A TOTAL OF TWO SURGERIES PERFORMED ON (B)(6) 2019 AND THIS WAS THE SECOND SURGERY OF THE DAY. ON (B)(6) 2019 THE CUSTOMER CONFIRMED THAT OVERCORRECTION WAS NOTICED ON BOTH THE EYES. THE PATIENT WAS MYOPIC AND NOW BECAME HYPEROPIC AFTER SURGERY. THE PATIENT WAS EXPERIENCING SYMPTOMS OF POOR VISION. THERE WAS NO SCHEDULE FOR RE-TREATMENT. THE DOCTOR SUGGESTED WATCHING THE PATIENT DURING RECOVERY TO BECOME STABLE PRIOR TO PLANNING ANY RE-TREATMENT. PRE OD: -8.63 D (ENTERED PRE OATZ NOMO), POST OD: + 1.50 D (AS

  Patient problems: Therapeutic Effects, Unexpected; Visual Impairment

  MAUDE report 8952638 ↗
• MalfunctionJan 15, 2019Calibration Problem; Calibration Problem

  ON (B)(6) 2018, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM THE USER FACILITY TO REPORT THAT THE ABLATION WAS OFF-CENTER ON THE EC-5000 QUEST SERIAL # (B)(4). THERE WAS NO INJURY REPORTED BY THE USER FACILITY AND THEY HAD REQUESTED SERVICE. ON JANUARY 15 2019, IT WAS CONFIRMED BY THE DOCTOR THAT HE OBSERVED THE ISSUE WHILE CHECKING THE ABLATION DURING A ROUTINE CALIBRATION ON THE DEVICE. THERE IS NO ADVERSE EVENT OR INJURY OCCURED SO NO PATIENT INFORMATION IS AVAILABLE. DECENTERED ABLATION IS AN INFREQUENT COMPLICATION OF LASER EYE SURGERY THAT OCCURS WHEN THE TREATMENT IS NOT PROPERLY CENTERED OVER THE PUPIL. LASER ABLATIONS THAT ARE OFF-CENTER BY AS LITTLE AS 0.5MM CAN CAUSE VISUAL SYMPTOMS, INCLUDING GLARE AND HALOS, GHOST IMAGES, AND BLURRED VISION. PER EC-5000 QUEST OPERATOR'S MANUAL, THE OPERATOR MUST MAKE SURE TO CALIBRATE THE ABLATION RATE BEFORE THE ACTUAL SURGERY. THE SYSTEM DOES NOT ALLOW SURGERY TO BE PERFORMED UNLESS THE ABLATION RATE IS CALIBRATED. ALTHOUGH NO PATIENT INJURY OCCURRED, NIDEK INC. CONSIDERS ABLATION OFF-CENTER ON THE EXCIMER LASER AS A REPORTABLE EVENT, AS THERE COULD BE POTENTIAL ADVERSE IMPACT TO THE PATIENT IF THE EVENT WAS TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8249410 ↗
• Apr 28, 2016Unexpected Therapeutic Results; Device Operates Differently Than Expected; Unexpected Therapeutic Results; Device Operates Differently Than Expected

  NIDEK INC. CUSTOMER SERVICE REPRESENTATIVE (REP.) RECEIVED A CALL ON (B)(4) 2016 FROM GENTLEMEN BY THE NAME OF (B)(6) COMPLAINING THAT HIS GIRLFRIEND RECEIVED LASIK FROM DR (B)(6) ON (B)(6) 2016. PATIENT REPORTED THAT DURING SURGERY, SHE HAD A MAJOR DAMAGE ON ONE EYE. AS PER THE REPORTER, DR (B)(6) INFORMED THAT THE LASER MADE A "J CUT" CAUSING DAMAGE TO THE PATIENT'S EYE (EYE LID). HOWEVER, NIDEK CUSTOMER SERVICE REP. INFORMED (B)(6) THAT NIDEK LASER DOES NOT PERFORM THE CUT AND THAT THERE IS A DIFFERENT PIECE OF EQUIPMENT THAT DOES THAT PORTION. (B)(6) ALSO MENTIONED THAT ON (B)(6) 2016 PATIENT RECEIVED PRK FROM DR (B)(6) ON THE OTHER EYE.

  Patient problems: Eye Injury

  MAUDE report 5618524 ↗