OPMI PICO SYSTEM
Received Aug 16, 2019 · Event occurred Jul 18, 2019
Report 9615010-2019-00006 · MDR key 8903732
Device
Generic name
Opmi Pico
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
N/ACatalog number
000000-2149-629
Lot number
N/A
Product problems
- Detachment of Device or Device Component
- Device Fell
- Detachment of Device or Device Component
- Device Fell
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED. FIELD G7: UPDATED TO "FOLLOW-UP #: 1". FIELD H2: ENTERED "DEVICE EVALUATION" . FIELD H3: UPDATED "EVALUATION SUMMARY ATTACHED". FIELD H6: CHANGED RESULT CODE TO "213". CHANGED CONCLUSION CODE TO "4310" AND "18". FIELD H10: ADDED DESCRIPTION OF CHANGES.
Description of Event or Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED TO ZEISS SALES REPRESENTATIVE THAT THE OPMI PICO HEAD SEPARATED FROM THE MORA INTERFACE WHILE BEING USED. THERE WAS NO INJURY REPORTED TO THE PATIENT, DOCTOR OR A THIRD PARTY.