MalfunctionHKO
VS100 SPOT VISION SCREENER
Received May 27, 2026 · Event occurred Apr 30, 2026
Report 1316463-2026-00305 · MDR key 25310632
Device
Generic name
Refractometer, Ophthalmic
Manufacturer
Baxter Healthcare CorporationModel number
901029Catalog number
106369
Lot number
N/A
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
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.
Remedial action
- Other