SMARTLOAD GCB00 (REF GCB0000245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474620698), received between Apr 11, 2022 and Jul 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834168 ↗
• MalfunctionDec 18, 2025Crack; Material Fragmentation; Device Difficult to Setup or Prepare; Crack; Material Fragmentation; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PLASTIC RIM OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) SYSTEM BROKE DURING LENS INJECTION INSIDE THE EYE OF THE PATIENT, RESULTING IN A FRAGMENT OF THE CARTRIDGE BEING RELEASED INTO THE EYE. THE CUSTOMER INDICATED EXPERIENCING RESISTANCE WHILE ADVANCING THE LENS THROUGH THE CARTRIDGE. THEY NOTED THAT A SIMILAR INCIDENT HAD PREVIOUSLY OCCURRED. THE LENS ITSELF REMAINED INTACT AND WAS SUCCESSFULLY IMPLANTED WITHOUT DAMAGE OR PATIENT INJURY. NO FURTHER INFORMATION HAS BEEN PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE OTHER OCCURRENCE OF THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846044 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED UPON OPENING THE PACKAGE. ACCOUNT INDICATED THAT THE LENS ITSELF WAS OBSERVED AS DAMAGED DURING PREPARATION. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO MATERIAL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834945 ↗
• MalfunctionJul 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHEN IMPLANTING A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED A METAL SPLINT BEING INJECTED INTO THE EYE. THE SPLINT WAS REMOVED. IT WAS CONFIRMED THROUGH FOLLOW UP THAT THE METAL SPLINT WAS REMOVED FROM THE PATIENT'S EYE DURING THE INITIAL PROCEDURE, THE LENS REMAINS IMPLANTED AND THE PATIENT IS UNAFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823358 ↗
• MalfunctionApr 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS AGO, THE SURGEON OBSERVED A METAL SPLINT IN THE DEVICE. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW-UP WE LEARNED THAT THE SURGEON OBSERVED A METAL SPLINT BEING INJECTED INTO THE EYE AT THE SAME TIME AS THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED. THE SPLINT HAS BEEN REMOVED. THE IOL REMAINS IMPLANTED AND THE PATIENT HAS FULLY RECOVERED. ACCOUNT INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076237 ↗
• MalfunctionOct 26, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS DELIVERED, IT WAS NOTICED THAT THE HAPTICS STUCK TOGETHER. THE SURGEON NEEDED A SECOND SIDE INSTRUMENT TO SEPARATE THEM. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT. THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT OUTCOME WAS GOOD AND THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012696 ↗
• MalfunctionApr 11, 2022Break; Contamination; Break; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE SURGEON NOTICED A SMALL SCRATCH LOOKING LIKE A DEFORMATION IN THE POSTERIOR SURFACE OF THE LENS AS THE IOL UNFOLDED. ACCOUNT INDICATED THAT THE SCRATCH WAS PARALLEL TO THE HAPTIC JUNCTIONS BUT CLOSER TO OPTIC EDGE RATHER THAN THE OPTIC AXEL ON THE RIGHT SIDE OF THE LENS. SURGEON WAS ABLE TO PARTIALLY CLEAN THE SCRATCH WITH A SINSKEY HOOK INSTRUMENT. ACCOUNT PROVIDED THAT THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED, THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) IN USE WAS DISCOVISC, AND THAT THE IOL WAS PLACED WITHOUT ANY ISSUES. THE PATIENT'S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. THE DOCTOR INDICATED THAT MONITORING THE PATIENT IS NOT NECESSARY AND NO EXPLANT IS BEING PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079615 ↗