Scanmate A DGH 6000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857377006094), received between Dec 20, 2016 and Jan 26, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 26, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISTRIBUTOR ((B)(4)) STATED THAT A USER (DR. (B)(6)) ALLEGED HIS DEVICE WAS NOT GIVING A PROPER READING WHEN PERFORMING MEASUREMENTS. WHEN CONTACTED FOR ADDITIONAL INFORMATION, DR. (B)(6) STATED THAT USING MEASUREMENTS TAKEN WITH THE DEVICE (FOR IOL CALCULATIONS) YIELDED A REFRACTIVE ERROR OF -3.00, -3.50 AND -2.50 DIOPTERS, WHICH WAS GREATER THAN THE DESIRED RESULT. DATES OF EVENT UNKNOWN. THE DOCTOR STATED THAT RAYNER INTRAOCULAR LENSES WERE USED (POWER AND MODEL UNKNOWN). PATIENT INFORMATION WAS NOT GIVEN, HOWEVER FROM THE DESCRIPTION PROVIDED IT APPEARS THAT PATIENTS EXPERIENCED THIS LEVEL OF REFRACTIVE ERROR FOLLOWING SURGERY. NECESSITY OF ADDITIONAL MEDICAL/SURGICAL INTERVENTION UNKNOWN.

  Patient problems: No Information

  MAUDE report 6281074 ↗
• MalfunctionDec 20, 2016Incorrect Measurement; Incorrect Measurement

  NOTIFICATION WAS RECEIVED FROM A DISTRIBUTOR ((B)(4)) WHOM DGH HAD SOLD A DEMONSTRATION DGH 6000 A-SCAN DEVICE. THIS DEVICE HAD BEEN PROVIDED BY THE DISTRIBUTOR TO A CUSTOMER FOR TRIAL USE. THIS DEVICE HAD BEEN IN SERVICE AT THE USER'S FACILITY FOR SEVERAL MONTHS (START DATE UNKNOWN), WITH THE TRIAL PERIOD ENDING ON (B)(6) 2016. IT WAS COMMUNICATED BY THE DISTRIBUTOR ((B)(4)) THAT OPERATORS OF THE DEVICE HAD COMPLAINED THAT IT TAKES TOO LONG TO BEGIN MEASUREMENT AND THAT THE READINGS ARE UNSTABLE. THE DISTRIBUTOR ((B)(4)) REQUESTED THAT SUPPORT INFORMATION BE PROVIDED BY DGH TO IMPROVE THE MEASUREMENT ACCURACY OF THE DEVICE. DURING SUBSEQUENT COMMUNICATION WITH THE DISTRIBUTOR, IT WAS REPORTED TO DGH THAT DURING THE TIME THE DGH 6000 WAS IN TRIAL USE, THERE WERE TEN (10) INSTANCES OF PATIENTS SHOWING A POST-OPERATIVE REFRACTIVE ERROR OF +1.50 THROUGH +2.00 DIOPTERS, AND ONE (1) INSTANCE OF A PATIENT SHOWING A POST-OPERATIVE REFRACTIVE ERROR OF +5.00 DIOPTERS. DURING THIS TIME, IT IS ESTIMATED THAT MORE THAN TWO-HUNDRED (200) PATIENTS' EYES RECEIVED SURGERY WITH ACCEPTABLE RESULTS (ACCEPTABLE BEING LESS THAN +1.50 DIOPTER REFRACTIVE ERROR). IT WAS REPORTED THAT THERE WERE NO SUBSEQU

  Patient problems: Visual Impairment

  MAUDE report 6190161 ↗
• MalfunctionDec 20, 2016Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A USER (DR. (B)(6)) ALLEGED EXPERIENCING MEASUREMENT ERRORS WHEN USING A DGH 6000 A-SCAN DEVICE. THE DOCTOR STATED THAT WHEN PERFORMING CONTACT AXIAL LENGTH MEASUREMENTS OF THE EYE, (IN APPROXIMATELY 2 OF EVERY 10 CASES) HE WOULD HAVE DIFFICULTY OBTAINING MEASUREMENTS. HE SAID IN THESE INSTANCES THE DEVICE WOULD ENTER ESTIMATE MODE AND MEASUREMENTS TAKEN WHILE IN ESTIMATE MODE DIFFERED FROM AXIAL LENGTH MEASUREMENTS ACHIEVED WITH HIS PREVIOUS A-SCAN DEVICE. THIS DIFFERENCE IN MEASUREMENT WOULD RESULT IN A REFRACTIVE CALCULATION ERROR OF 2-3 DIOPTERS. THE DOCTOR CLAIMED THAT INSTANCES OF DIFFICULTY WERE TYPICALLY EXPERIENCED WHEN ATTEMPTING TO MEASURE EYES WITH A MATURE CATARACTS OR POSTERIOR SUB CAPSULAR CATARACT (PSC). HE STATED THAT IN OTHER CASES (WHEN NOT MEASURING MATURE CATARACTS OR POSTERIOR SUB CAPSULAR CATARACT), THE READINGS ARE SATISFACTORY AND ACCURATE. MEASUREMENT INFORMATION FOR ONE PATIENT ((B)(6)) WAS PROVIDED, WHOSE MEASUREMENTS DIFFERED BY 0.75 MM WHEN COMPARED TO THE PREVIOUS DEVICE. THE DOCTOR HAS STATED THAT NO INJURIES HAVE OCCURED AS A RESULT OF THE MEASUREMENT DIFFERENCE. IN CASES WHERE MEASUREMENTS OBTAINED WITH THE DGH 6000 DIFFERED FROM HIS PREVIOUS DEVIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190143 ↗