SMARTLOAD GCB00 (REF GCB0000165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474620537), received between Apr 11, 2022 and Dec 12, 2024 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERIES, 6 OF 11 PATIENTS NOW RECEIVE TREATMENT IN THE HOSPITAL. BACTERIAL INFECTION IS SUSPECTED. PATIENT NUMBER 6 HAD BOTH EYES TREATED. THE CLINIC USED A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FOR THESE PATIENTS, BUT THE SURGEON DOES NOT EXPECT THE IOLS TO BE THE SOURCE OF THE INFECTION. ALL OTHER EQUIPMENT USED FOR THE PROCEDURES WERE FROM OTHER SUPPLIERS. ACCOUNT INDICATED THAT THE OTHER 5 PATIENTS ARE WELL (PATIENTS WITHOUT THE INFECTION POST SURGERY). IT WAS ALSO CONFIRMED THAT ALL SURGERIES TOOK PLACE ON THE SAME DATE. OVERNIGHT HOSPITAL STAY AND MEDICAL INTERVENTIONS WERE REQUIRED. PATIENTS HAVE BEEN DIAGNOSED WITH ENDOPHTHALMITIS. NO SOURCE OF THE INFECTION HAS BEEN FOUND YET AS PER IN-HOUSE INVESTIGATION. THERE IS NO FURTHER PATIENT OUTCOME INFORMATION. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED. NOTE: SEPARATE COMPLAINTS HAVE BEEN CREATED FOR EACH OF THE 6 PATIENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 1.

  Patient problems: Endophthalmitis

  MAUDE report 20918706 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT THE LENS WAS DEFECTIVE. IT WAS INDICATED THAT THE LENS HAS BEEN THROWN AWAY AND THERE IS NO WAY TO TRACE THE PROBLEM. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14762128 ↗
• 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 14079816 ↗