Device product
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Z-1539-2018
Product summary
- Event
- Event 79908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 total products
- Official record key
device-enforcement:Z-1539-2018
Official wording
Reason: Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Code information: Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899
Distribution pattern: Distributed to the states of OH, NY, FL, MN, and KS.
Derived failure modes
-
Unknown
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.