SMARTLOAD GCB00 (REF GCB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474620582), received between Sep 12, 2022 and Jan 30, 2026 — classified as 2 injuries, 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 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.

• MalfunctionJan 30, 2026Contamination

  IT WAS REPORTED THAT DURING A LEFT EYE PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) INSERTION PROCEDURE, A FIBER WAS FOUND WRAPPED AROUND THE PRE-LOADED LENS. THE SURGEON REMOVED THE FIBER FROM THE EYE AND CONTINUED WITH THE SURGERY. THE OPERATION WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229017 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516072 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF SEVERE HALOS AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED, THAT THE PATIENT HAD A YTTRIUM ALUMINIUM GARNET (YAG) CAPSULOTOMY IN (B)(6) 2023 AND SICCA THERAPY WAS PRESCRIBED WHICH THE PATIENT DISCONTINUED. HE HAD A RESIDUAL REFRACTIVE ERROR OF +1.25 IN (B)(6) 2023 AND STILL COMPLAINS ABOUT HALOS. HE IS CURRENTLY STILL DRIPPING PILOCARPINE, WHICH MAKES THE PUPIL MUCH SMALLER IN THE DARK AND HE COPES MUCH BETTER WITH THE HALOS. BUT THE MAIN PROBLEM AT THE MOMENT IS THE DRYNESS. UNFORTUNATELY, HE ALSO SMOKES AND THE DOCTOR DOUBTS WHETHER IT WILL REALLY GET BETTER. HE WILL NOW COME BACK IN 4 WEEKS FOR A CHECK-UP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 18136565 ↗
• InjuryJul 24, 2023Ejection Problem; Ejection Problem

  THE INTRAOCULAR LENS (IOL) WAS NOT ADVANCING CORRECTLY IN THE CARTRIDGE AND GOT STUCK IN THE EYE. THE SURGEON PROCEEDED TO REMOVE IT AND USED THE BACKUP. THE INCISION WAS ENLARGED AND NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17385529 ↗
• MalfunctionSep 12, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A DEFECT OCCURRED DURING LOADING WITH AN INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP, IT WAS LEARNT THAT THE SURGEON DID NOT PROCEED WITH THE IMPLANT AND THE LENS DID NOT COME INTO CONTACT WITH THE PATIENT. THE LENS WAS REPORTED DEFECTIVE AND UNUSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407455 ↗