VARI-LASE IPN913598Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156101008), received between Jun 24, 2021 and Jun 24, 2021 — classified as 1 injury.

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

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

• InjuryJun 24, 2021Separation Problem; Separation Problem

  AS REPORTED: THE METAL TIP OF THE LASER FIBER WENT MISSING WHEN THE CONSULTANT REMOVED THE FIBER AFTER THE EVLT PROCEDURE ON THE 2ND LEG (RIGHT SIDE) SCHEDULED FOR BILATERAL EVLT USING VARILASE PLATINUM BRIGHT TIP LASER FIBER WITH LOT NUMBER 707549 AND REF COMPONENT #7147C. PACKAGING MODEL # 7172. XRAY WAS DONE TO CONFIRM THE LOCATION OF THE METAL TIP WHICH WAS FOUND ON THE RIGHT LEG AND EXTRACTED WITH MINIMIZED SKIN INCISION. DURING THE PROCESS OF REMOVAL, THE TIP WAS CRUSHED BUT WAS REMOVED COMPLETELY AS CONFIRMED BY XRAY. THERE WERE NO FURTHER PROBLEMS DURING THE PROCEDURE. A FULL LENGTH COMPRESSION BANDAGE WAS APPLIED AND THE PATIENT WENT HOME THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12061424 ↗