SMARTLOAD GCB00 (REF GCB0000265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474620735), received between Jun 13, 2022 and Mar 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A POST-OPERATIVE EXAMINATION, DAMAGE TO THE OPTIC WAS DETECTED AFTER IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE LENS WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE. REPORTEDLY, THERE WAS NO RESISTANCE IN THE INJECTOR DURING THE LOADING PROCESS. THE PATIENT HAS FULLY RECOVERED AND THE EVENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE DELAY TO THE PROCEDURE WAS NOT SIGNIFICANT. NO MATERIAL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723131 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE WHEN OPENING THE PACKAGE. THE ISSUE WAS FIRST IDENTIFIED UPON OPENING OF THE PACKAGING AND THERE WAS NO CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS CAME CROOKED OUT OF THE CARTRIDGE AND THE LENS WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023504 ↗
• MalfunctionJun 13, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER THE LENS WAS IMPLANTED THE DOCTOR SAW A FOREIGN BODY SHAPED LIKE A RING. THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE AND THE LENS REMAINS IMPLANTED. A DELAY IN THE PROCEDURE WAS MENTIONED; HOWEVER, NO MEDICATION OR SURGICAL INTERVENTION WAS REQUIRED. NO IMPACT ON DAILY ACTIVITIES REPORTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682567 ↗