MalfunctionHKO
VS100 SPOT VISION SCREENER
Received Jul 8, 2026
Report 1316463-2026-00316 · MDR key 25757549
Device
Generic name
Refractometer, Ophthalmic
Manufacturer
Baxter Healthcare CorporationModel number
901029Catalog number
VS100S-B
Lot number
NI
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 CORD. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Remedial action
- Other