Device product
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
Z-1888-2024
Product summary
- Event
- Event 94545
- Status
- Ongoing
- Classification
- Class II
- Quantity
- pending
- Official record key
device-enforcement:Z-1888-2024
Official wording
Reason: Potential for distal end of the sheath to break off during a procedure.
Code information: Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers.
Distribution pattern: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
Derived failure modes
-
Unknown
Potential for distal end of the sheath to break off during a procedure.