SMARTLOAD GCB00 (REF GCB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474620551), received between Jul 11, 2023 and Feb 23, 2026 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) DETACHED AND WAS LEFT BEHIND IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423323 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS UNSATISFIED WITH THE RESULTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT'S LEFT EYE UNCORRECTED VISUAL ACUITY WAS +0.1 BEFORE THE SURGERY AND +0.5 AFTER THE SURGERY. THE IOL WAS EXPLANTED AND REPLACED WITH A JOHNSON AND JOHNSON AR40E MODEL IOL. THE PATIENT DID NOT PRESENT ANY OTHER VISUAL PROBLEMS OR INJURIES. NO OTHER MEDICAL INTERVENTIONS WERE PERFORMED, AND NO ISSUES WITH THE IOL WERE REPORTED. THIS EVENT WAS NOT DEBILITATING TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Discomfort

  MAUDE report 19620129 ↗
• MalfunctionOct 18, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME IN ON THE WRONG SIDE. THE PHYSICIAN DID NOT KNOW IF THIS WAS CAUSED BY HIM OR IF THE LENS WAS PLACED INCORRECTLY IN THE CARTRIDGE. THE PHYSICIAN FLIPPED THE LENS IN THE EYE AND EVERYTHING WAS FINE, THE PATIENT IS FULLY RECOVERED. NO MEDICAL INTERVENTIONS WERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE SURGEON USED HIS NORMAL SIDE INSTRUMENTS. NO PRODUCT IS AVAILABLE FOR INVESTIGATION AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961036 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. STATUS OF PATIENT CONTACT WITH THE PRODUCT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302932 ↗