InstaClear LCTS100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925040052), received between Jan 5, 2021 and Feb 12, 2025 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367620 ↗
• MalfunctionJul 8, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR AN ENDOSCOPIC NASAL SINUS SURGERY PROCEDURE, THE UNOPENED STERILE PACK OF LCTS100S WAS FOUND WITH A FOREIGN MATTER THAT LOOKED LIKE A HAIR. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT MODEL. THE INTENDED PROCEDURE WAS COMPETED WITH NO IMPACT OR HARM TO THE PATIENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140109 ↗
• MalfunctionJan 5, 2021Packaging Problem; Packaging Problem

  DURING PREPARATION FOR USE, THE BOX OF THE LENS CLEANER TUBESET /5PACK WAS OPENED AND THE STERILIZATION PACKAGING WAS DIRTY (YELLOWING). THE ISSUE WAS ONLY OBSERVED ON ONE PACKAGE AND NOT FOR OTHER BUNDLED PRODUCTS. A DEVICE FROM THE SAME LOT WAS USED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11117297 ↗

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