SMARTLOAD GAB00 (REF GAB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474621831), received between Apr 22, 2021 and Mar 12, 2025 — classified as 1 injury, 2 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 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.

• MalfunctionMar 12, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) BROKE WHILE USING THE APPROPRIATE INJECTOR. THE PROCEDURE WAS THE SAME AS ALWAYS, FOLLOWING THE SPECIALIST'S INSTRUCTIONS. WHEN PUSHING THE LENS SLOWLY INTO THE CARTRIDGE, A GREATER FRICTION THAN USUAL WAS OBSERVED. ALTHOUGH THE SURGEON ATTEMPTED TO RECOVER THE LENS, IT WAS IRREVERSIBLY DAMAGED; THEREFORE, THE IOL WAS REPLACED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590205 ↗
• MalfunctionMar 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PLASTIC RESIDUE CAME OUT OF THE SHOOTER WHILE INSERTING THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE SURGEON HAD TO USE A PHACO SPATULA TO REMOVE THE INDIVIDUAL PLASTIC RESIDUES FROM THE ANTERIOR CHAMBER AND FROM THE IOL. ALL RESIDUES WERE REMOVED. THE LENS REMAINS IMPLANTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540263 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CASE OF POST-OPERATIVE ENDOPHTHALMITIS. THE DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED AND A VITRECTOMY WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 11705180 ↗