VERION REFERENCE UNIT
Received Jun 26, 2015 · Event occurred Jun 25, 2014
Report 3010300699-2015-00506 · MDR key 4871813
Device
Generic name
Keratometer, Pupillometer
Manufacturer
Wavelight Gmbh (agps)Model number
X-RUSCatalog number
8065998240
Lot number
ASKU
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- Therapeutic Effects, Unexpected
Narrative
Additional Manufacturer Narrative
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Additional Manufacturer Narrative
NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. CONTRIBUTING FACTORS FOR REPORTED ISSUE COULD BE ATTRIBUTED TO A POOR DIAGNOSTIC IMAGE, USE OF A NON OPTIMIZED FORMULA DURING PLANNING, OR INCORRECT PATIENT DATA ENTRY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NURSE REPORTED A CASE OF A TORIC INTRAOCULAR LENS EXPLANTED, AND INDICATED A DIAGNOSTIC CALCULATION ERROR CREATED AN UNEXPECTED REFRACTIVE OUT-COME. UPON ADDITIONAL FOLLOW UP, THE REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION.
Remedial action
- Other