InstaClear LCS4K30TPOLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925041479), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K152531); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE WHEN PLACING THE SHEATH ABOVE THE OPTIC IN THE STERILE FIELD OF THE UNIT, A METAL PART WAS RELEASED AND THE END OF THE SHEATH WAS OBSERVED WITH A CUTTING EDGE. DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10874805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152531. One submission often covers many models, so check the product and lot details in each record.

• Z-1888-2024 · Apr 3, 2024 · Open, Classified
  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 remo
• Z-1368-2024 · Jan 16, 2024 · Open, Classified
  InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LC