Welch Allyn, Inc. 901029 (REF VS100-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn VS100 Spot Vision Screener with Wrist Strap and 8' (2.5m) US Power Cord (2.5A, 125V) (Carrying Case not Included) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00732094212235), received between Nov 25, 2024 and Aug 7, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (17 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn17
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Material Split, Cut or Torn
Baxter received a report stating that VS100 Spot Vision Screener had its power cord damaged with exposed copper wires. The process step during which this occurred was unknown. There was no report of patient injury or medical intervention associated with these events.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184461 ↗MalfunctionJul 27, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025324 ↗MalfunctionJul 27, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014269 ↗MalfunctionJul 8, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD A FRAYED POWER CORD. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25757549 ↗MalfunctionJul 7, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741758 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD A BROKEN POWER CORD. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340182 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD A BROKEN POWER CORD. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340052 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD A BROKEN POWER CORD. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338127 ↗MalfunctionMay 27, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD A FRAYED POWER SUPPLY WITH EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310632 ↗MalfunctionMay 26, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT STATING THAT A VISION SCREENER HAD EXPOSED WIRES TOWARDS THE POWER SUPPLY BRICK. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25292970 ↗MalfunctionMay 15, 2026Insufficient Device Problem Information
THE CUSTOMER REPORTED THE POWER SUPPLY WAS DAMAGED. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194059 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960621 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694032 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694024 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693878 ↗MalfunctionMar 19, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24645975 ↗MalfunctionJan 12, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THE POWER CORD HAD EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24045112 ↗MalfunctionNov 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT VS100 CHARGING STRAIN RELIEF HAD COPPER WIRES SHOWING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772359 ↗
Other Refractometer, ophthalmic devices
- Welch Allyn, Inc. 901029Welch Allyn, Inc. · Refractometer, ophthalmic1 recall11 reports
- Welch Allyn, Inc. 901122Welch Allyn, Inc. · Refractometer, ophthalmic1 recall0 reports
- Welch Allyn, Inc. 901122Welch Allyn, Inc. · Refractometer, ophthalmic1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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