SMARTLOAD GAB00 (REF GAB0000250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474621886), received between Apr 7, 2022 and Apr 13, 2026 — classified as 3 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 3 most recent of 3 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 24867166 ↗
• MalfunctionMay 12, 2025Crack; Device Difficult to Setup or Prepare; Mechanical Jam; Crack; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED BY SURGEON THAT THERE WAS RESISTANCE UPON INSERTION OF MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) INSIDE PATIENT'S EYE. ACCOUNT REPORTED THAT THE CARTRIDGE TIP WAS PROBABLY BLOCKED AND LENS WAS COMING OUT AT THE SIDE OF THE TIP INSTEAD. CARTRIDGE TIP WAS IN CONTACT WITH PATIENT'S EYE. SUTURES WERE NOT REQUIRED. VITRECTOMY WAS NOT REQUIRED. THERE WAS NO DELAY IN PROCEDURE. END USER DIDN'T SEEK MEDICAL ATTENTION. NO MEDICATIONS WERE PRESCRIBED. PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006898 ↗
• MalfunctionApr 7, 2022Contamination; Contamination

  IT WAS REPORTED THAT A METALLIC-LOOKING FRAGMENT, RETAINED BETWEEN THE IOL (INTRAOCULAR LENS) AND THE ANTERIOR LENS CAPSULE AND 2 PUNCTATE FRAGMENTS REFLECTIVE IN THE IRIS STROMA WERE OBSERVED. THE ISSUE WAS IDENTIFIED WITH THE PATIENT'S RIGHT EYE DURING A POST OPERATIVE EXAM. THERE WAS NO VITRECTOMY REQUIRED AND NO DELAY WAS REPORTED. THE PATIENT REMAINS ASYMPTOMATIC AND THE REMOVAL OF THE INTRACAPSULAR FRAGMENT IS NOT PLANNED FOR NOW. THE POST-OP VISION WAS DESCRIBED AS GOOD, PATIENT HAS FULLY RECOVERED AND NO MEDICATION WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE INTRAOCULAR LENS DEVICE. SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14039099 ↗