SMARTLOAD GCB00 (REF GCB0000270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474620742), received between Feb 21, 2023 and Apr 7, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionApr 7, 2026Ejection Problem

  IT WAS REPORTED THAT LENS THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) MISFIRED DUE TO THE LENS STICKING DURING INJECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811336 ↗
• 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, RESULTING IN A FRAGMENT OF THE CARTRIDGE BEING RELEASED INTO THE PATIENT'S 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. NOTE: THIS REPORT IS TO CAPTURE THE SIMILAR INCIDENT THAT OCCURRED PREVIOUSLY. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE CURRENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846187 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED EIGHT CATARACT SURGERIES ON THE SAME DAY BEFORE EASTER. AT THE WEEKLY CHECK-UP EVERYTHING LOOKED FINE, BUT AT THE MONTHLY CHECK-UP THERE WAS A CLOUDY LIGHT PATH IN 3 EYES. WHEN TREATED WITH SPERSADEX IT DISAPPEARED QUICKLY. THE SURGEON DOES NOT SUSPECT OUR PRODUCTS AND HAS CHANGED EVERYTHING THAT CAN BE CHANGED. THROUGH FOLLOW UPS IT WAS CONFIRMED THAT THE 3 EYES WERE FROM 3 DIFFERENT PATIENTS. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT 7 PATIENTS ARE INVOLVED AND THERE ARE 3 DIFFERENT EVENT DATES. IT WAS CONFIRMED THAT THE CUSTOMER IS REPORTING INFECTION IN ALL 7 PATIENTS. HOWEVER, ON (B)(6), IT WAS LEARNED THAT THE SURGEON DOES NOT BELIEVE THIS INCIDENT IS RELATED TO THE IMPLANTED JOHNSON AND JOHNSON INTRAOCULAR LENSES (IOLS). THROUGH FOLLOW UP ON (B)(6), WE LEARNED IT WAS A MILD INFECTION, ALL PATIENTS RESPONDED FAST TO TOBRADEX EXCEPT ONE THAT TOOK A LITTLE MORE TIME. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION AS ALL IOLS REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. NOTE: 6 ADDITIONAL REPORTS WILL BE FILED FOR THE OTHER 6 PATIENTS. THIS IS REPORT 3 OF 7.

  Patient problems: Eye Infections

  MAUDE report 22237906 ↗
• MalfunctionFeb 21, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A DENT ON THE INTRAOCULAR LENS (IOL). THE DOCTOR HAS PLACED THE LENS IN SUCH A WAY THAT THE PATIENT WILL NOT FEEL ANY DISCOMFORT. THROUGH FURTHER FOLLOW-UP THE DOCTOR CONFIRMED THAT THE IOL REMAINS IMPLANTED AND THE PATIENT HAS NO NEGATIVE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414499 ↗