SMARTLOAD GCB00 (REF GCB0000255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474620711), received between May 10, 2019 and Nov 6, 2025 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED AND WAS DAMAGED DURING THE INSERTION PROCESS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493108 ↗
• MalfunctionMay 10, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEBRIS WAS FOUND ON THE INTRAOCULAR LENS (IOL) WHICH LOOKED LIKE A LONG SLENDER FLAKE ABOUT 1MM IN LENGTH. THE DEBRIS WAS NOT SOLID LIKE PLASTIC BUT MORE LIKE SOMETHING DRIED UP. THE DEBRIS WAS REMOVED WITH IRRIGATION/ASPIRATION (IA). THE DEBRIS DISINTEGRATED WITH I/A AND WAS SEEN WHEN THE IOL UNFOLDED. IT DISINTEGRATED WHEN THE SURGEON COMPLETED THE CASE WITH I/A WHICH IS STANDARD PROCEDURE AT THE END OF THE CATARACT PROCEDURE TO REMOVE ANY REMAINING OVD (OPHTHALMIC VISCOSURGICAL DEVICE) LEFT IN THE EYE FROM THE CASE. THERE WAS NO TREATMENT GIVEN FOR THIS AND THERE WAS NO ADVERSE EVENT OR PATIENT ISSUES CAUSED BY IT. PATIENT HAD RECOVERED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601843 ↗