SMARTLOAD GAB00 (REF GAB0000180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474621749), received between Feb 22, 2022 and Mar 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMar 14, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT WHEN POSITIONING THE PRELOADED INTRAOCULAR LENS (IOL), AIR BUBBLES WERE NOTICED IN THE OPTIC OF THE LENS. THE IOL WAS IMPLANTED AND REMAINS IN THE PATIENT'S EYE. ACCORDING TO THE CUSTOMER, THE LENS WAS LEFT IN THE EYE WITH NO PLAN TO BE REMOVED. THE PATIENT DOES NOT HAVE ANY SYMPTOMS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607793 ↗
• MalfunctionFeb 12, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN WHEN OPENED. THROUGH FOLLOW-UP, WE LEARNED THAT DURING IMPLANTATION THE LENS ENCOUNTERED EXCESSIVE RESISTANCE AS IF IT WERE BLOCKED IN THE CARTRIDGE. AT THAT MOMENT, IT WAS OBSERVED THAT THE IOL WAS BROKEN. NO SURGICAL OR MEDICAL INTERVENTIONS WERE NECESSARY DUE TO THIS ISSUE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370569 ↗
• MalfunctionFeb 22, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHEN IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A PIECE OF MATERIAL (POSSIBLY A PARTICLE/PIECE FROM THE CUTTING PROCESS) CAME OUT. THE FOREIGN MATERIAL WAS REMOVED FROM THE PATIENT'S EYE AS SOON AS IT WAS DETECTED BY MANIPULATING THE IOL'S SURFACE WITH VISCOELASTIC TO SEPARATE IT FROM THE ANTERIOR FACE OF THE LENS. THERE WAS AN INCREASE IN THE SURGICAL TIME AND INTRAOCULAR MANIPULATION, WITH NO FORESEEN CONSEQUENCES FOR THE PATIENT. THE LENS REMAINS IMPLANTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582146 ↗