SMARTLOAD GCB00 (REF GCB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474620612), received between Nov 1, 2021 and Jun 26, 2025 — classified as 2 injuries, 2 malfunctions.

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

• InjuryJun 26, 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 JUNE 13TH 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 JUNE 16TH 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 7 OF 7.

  Patient problems: Eye Infections

  MAUDE report 22342864 ↗
• MalfunctionApr 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON NOTICED A METAL SPLINT BEING INJECTED INTO THE EYE, AT THE SAME TIME AS THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED. THE METAL SPLINT WAS REMOVED. NO INFORMATION WAS PROVIDED ABOUT ANY PATIENT COMPLICATIONS. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION / APPLICATION. THE IOL WAS FULLY INSERTED AND NO MEDICATIONS WERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THERE WAS NO RESISTANCE FELT DURING LENS PREPARATION. IT IS UNKNOW IF THE FOREIGN MATERIAL CAME FROM THE LENS OR THE INSERTER. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE INSERTER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076425 ↗
• MalfunctionAug 16, 2023Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) COULD NOT BE LOADED ONTO THE CARTRIDGE AND THE LENS WAS CUT OFF. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559819 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) . ACCORDING TO THE CALCULATIONS THE TARGET WAS PLANO. NO COMPLICATIONS OR ANYTHING EXCEPTIONAL DURING THE PROCEDURE WAS NOTED, HOWEVER, DURING THE POST-OPERATIVE (OP) CHECK, A SURPRISE REFRACTION OF +4 WAS OBSERVED. THE SURGEON DECIDED TO EXPLANT THE LENS AND BASED ON POST-OP RESULTS, ANOTHER JOHNSON & JOHNSON A GCB00 26.0D LENS (SAME MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO COMPLICATIONS NOR EXCEPTIONS OCCURRED DURING THE EXPLANT PROCEDURE. IN POST-OP CHECK THE REFRACTION WAS NOTED AS -3,75. THE SURGEON DECIDED TO CHANGE THE LENS ONE MORE TIME. THE SECOND EXPLANT WAS DONE ON THE (B)(6) 2021 AND ANOTHER JOHNSON & JOHNSON A GCB00 21.0D LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO COMPLICATIONS NOR EXCEPTIONS IN THE OPERATION NOTED AGAIN. ALL MATERIALS HAVE BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS HAD BEEN IMPLANTED INTO THE RIGHT EYE (OD) AND NO PATIENT ANATOMIES ISSUES WERE FOUND. THE INITIAL LENS LOOKED LIKE IT WAS SITTING NICELY CENTERED, BUT MAYBE LITTLE POSTERIORLY BEHIND THE IRIS LEVEL. NOW AF

  Patient problems: Visual Impairment

  MAUDE report 12734054 ↗