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Recall Observatory FDA recall evidence

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

April 03, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
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

    reason.no_named_rule · v1.0.0

    Potential for distal end of the sheath to break off during a procedure.