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U.S. Department of Health and Human Services

Class 2 Device Recall InstaClear Lens Sheath

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 Class 2 Device Recall InstaClear Lens Sheathsee related information
Date Initiated by FirmApril 03, 2024
Date PostedMay 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1888-2024
Recall Event ID 94545
510(K)NumberK152531 
Product Classification Nasopharyngoscope (flexible or rigid) - Product Code EOB
ProductInstaClear 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.
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.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Potential for distal end of the sheath to break off during a procedure.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at Cynthia.Ow@olympus.com.
Quantity in Commercepending
DistributionDomestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOB
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