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InstaClear LCS1500UNOLRecalls & reported problems

Gyrus ACMI, LLC · SHEATH, LENS CLEANER OLYMPUS 0 DEGREES, for use with Olympus 4 x 150 mm scopes UNIVERSAL LIGHT InstaClear (5/PK) · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925040137), received between Nov 17, 2022 and Jul 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

  1. Apr 3, 2024Open, Classified

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

    Z-1888-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE INSTACLEAR SYSTEM (INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION) DURING A THERAPEUTIC ENDOSCOPIC NASAL SURGERY, THE PROTUBERANCE AT THE TIP OF THE LENS CLEANING SHEATH BROKE OFF. IT FELL INTO THE PATIENT¿S NOSE, BUT IT WAS REMOVED AFTER BEING CONFIRMED ON ENDOSCOPIC IMAGE. THE USER NOTED THEY DO NOT KNOW HOW TO PUSH THE RIGID ENDOSCOPE. THERE WERE NO ALLEGATIONS OF PATIENT EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17294945 ↗
  • MalfunctionNov 17, 2022Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED WHEN THE STERILIZATION PACK WAS LIFTED , THE CONTENTS SUDDENLY FELL OUT AND FOUND THE STERILE PACK WAS NOT SEALED ON THE SIDE OPPOSITE OF THE OPENING. THE ISSUE OCCURRED AT PREPARATION FOR USE FOR A THERAPEUTIC NASAL ENDOSCOPIC SURGERY. THE DEVICE WAS REPLACED. INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15812517 ↗

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-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

Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices

All NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.