STENTube Lacrimal Intubation Set LIS052Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10634624815527), received between Jun 23, 2016 and Sep 1, 2017 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2017Device Slipped

  THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE LACRIMAL INTUBATION TUBE DURING USE. THE REPORT STATED THAT THE CATHETER WAS "SLIPPING OUT OF THE SILVER (DELIVERY TUBE)." THE REPORT STATED THE PHYSICAL COULD NOT GET IT TO STAY IN THE TUBE SO THAT IT COULD BE PUT INTO PLACE, AND THAT THIS ACTUALLY OCCURRED WITH TWO DEVICES. AS A RESULT OF THE ALLEGED ISSUE, THE PHYSICIAN OPENED A 3RD STENT AND TIED A 7-0 SILK AROUND IT SO THAT THE CATHETER WOULD NOT SLIDE OUT OF THE DELIVERY TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840482 ↗
• MalfunctionAug 3, 2017Break

  THE FACILITY'S PURCHASING COORDINATOR REPORTED THAT WHEN THE PHYSICIAN WAS USING THE LACRIMAL INTUBATION SET, THE TUBING BROKE ON 4 OF THEM (SAME LOT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED REPORT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762653 ↗
• InjuryJun 20, 2017Detachment of Device or Device Component

  THE SURGERY CENTER REPORTED AN ISSUE WITH THE STENTUBE LACRIMAL INTUBATION DEVICE DURING USE. THE SURGEON REPORTED THAT OF THREE (3) DEVICES THEY USED, THEY "JUST FELL APART" DURING USE. THERE WAS NO ADDITIONAL DETAILS PROVIDED OTHER THAN THEY WERE FROM THE SAME LOT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE ACTUAL DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, ONE REMAINING DEVICE FROM THE SAME LOT WAS RETURNED TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6656085 ↗
• MalfunctionMar 23, 2017Break; Device Damaged Prior to Use; Device Operates Differently Than Expected

  THE USER FACILITY NOTIFIED THE MANUFACTURER THAT THEY HAVE HAD MULTIPLE FAILURES OF THE MODEL LIS052 STENT TUBES. THEY STATED THEY HAD RECEIVED 6 BOXES (2 INTUBATION TUBES PER BOX) BUT THE FIRST 3-4 BOXES FAILED DUE TO "LITERALLY FALLING APART" WITH THE SILICONE WAS COMING OFF AS THE SURGEON TRIED TO PLACE THEM DURING THE PROCEDURES. NO SPECIFIC DETAILS REGARDING ANY OF THE PROCEDURES OR PATIENTS WAS PROVIDED; HOWEVER, THERE WAS NO MENTION OF ANY PATIENT COMPLICATIONS AS A RESULT OF THE ALLEGED EVENTS STATED IN THE ORIGINAL REPORT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM USER FACILITY HAVE NOT BEEN SUCCESSFUL. USER FACILITY INDICATED THEY WERE RETURNING A SAMPLE FOR EVALUATION BUT NO SAMPLES HAVE BEEN RETURNED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428414 ↗
• InjuryMar 22, 2017Disassembly

  THE MATERIALS MANAGER OF THE SURGERY CENTER REPORTED THAT AN ISSUE WAS ENCOUNTERED WITH THE STENT TUBE INTUBATION SET DURING USE. THE REPORT STATED THAT DURING A PROCEDURE, ONE OF THE STENT TUBES "FELL APART." THE REPORT STATED THAT THE SURGEON HAD USED ONE OF THE STENT TUBES FROM THE BOX, BUT THE OTHER FELL APART SO HE OPENED ANOTHER BOX TO OBTAIN A THIRD ONE FOR USE. THERE WAS NO INFORMATION PROVIDED REGARDING THE PATIENT. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE SET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6426350 ↗
• InjuryJun 23, 2016Break; Material Fragmentation

  THE HOSPITAL PURCHASING DEPARTMENT REPORTED AN ISSUE ENCOUNTERED BY THE PHYSICIAN WHILE USING THE LACRIMAL INTUBATION SET. THE REPORT STATED THAT PIECES OF THE DEVICE BROKE INTO THE PATIENT'S EYE WHILE THE PHYSICIAN WAS INSERTING IT DURING A RIGHT ENDOSCOPIC DACRYOADENOTOMY. THE REPORT STATED THE SURGICAL SITE WAS EXAMINED TO RETRIEVE THE BROKEN PIECES AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION; IT IS WITH THE HOSPITAL'S CLINICAL ENGINEERING DEPARTMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5746348 ↗