SMARTLOAD GAB00 (REF GAB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474621794), received between Mar 12, 2025 and Apr 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT THE PLASTIC MATERIAL AT THE TIP OF THE INTRAOCULAR LENS (IOL) CARTRIDGE WAS FOUND TO BE DAMAGED AND HAD BROKEN OFF. THE MATERIAL WAS REMOVED BEFORE THE LENS WAS INSERTED, AND NO ADVERSE EFFECTS OR CLINICAL COMPLICATIONS WERE OBSERVED IN THE PATIENT. THE PROCEDURE WAS NOT DELAYED, NO ADDITIONAL INTERVENTIONS WERE REQUIRED, AND THE PATIENT FULLY RECOVERED WITH DAILY ACTIVITIES UNAFFECTED. ISSUE WAS OBSERVED DURING LENS IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867159 ↗
• MalfunctionJul 21, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), A SMALL HAIR OR LINT WAS DISCOVERED. THE IOL WAS FULLY IMPLANTED. THE FOREIGN MATERIAL WAS REMOVED IMMEDIATELY AND THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, WE LEARNED THAT THE FOREIGN MATERIAL WAS DISCARDED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561799 ↗
• MalfunctionApr 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE, IT WAS TORN. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936791 ↗
• MalfunctionMar 18, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THE LENS BECAME STUCK IN THE CARTRIDGE, CAUSING THE CARTRIDGE TO BREAK AND MAKING IT IMPOSSIBLE TO EXTRACT THE LENS. THE IOL WAS REPLACED WITH A BACK UP LENS. THROUGH FOLLOW UP, WE LEARNED THAT THE DAMAGE WAS ON THE TIP OF THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638901 ↗
• 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 21590177 ↗