SMARTLOAD GCB00 (REF GCB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474620667), received between Jul 6, 2021 and Jun 16, 2026 — classified as 4 injuries, 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), IT RELEASED DEBRIS INTO THE CAPSULAR BAG. NO IMPACT ON THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524406 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB MODEL INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, TUBING SETS, AND DK9000 AS THEY WERE USED ON EACH PATIENT. AS THE DK9000 IS A DEVICE THE CLINIC STERILIZES THEMSELVES, THIS IS LISTED AS A CONCOMITANT DEVICE AND NOT BEING REPORTED AGAINST. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL

  Patient problems: Endophthalmitis

  MAUDE report 25452007 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FOUND DAMAGED. ISSUE OBSERVED UPON OPENING OF THE PACKAGING. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032103 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) INFECTIONS WERE OBSERVED IN DIFFERENT PATIENTS ASSOCIATED WITH SIX DIFFERENT PRODUCT SERIAL NUMBERS. PATIENTS EXPERIENCED INFECTION, SOUGHT MEDICAL ATTENTION, AND WERE PRESCRIBED MEDICATION. ALL PATIENTS WERE REPORTED AS FULLY RECOVERED ALTHOUGH THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED DURING THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH PATIENT/ LENS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23985541 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) INFECTIONS WERE OBSERVED IN DIFFERENT PATIENTS ASSOCIATED WITH SIX DIFFERENT PRODUCT SERIAL NUMBERS. PATIENTS EXPERIENCED INFECTION, SOUGHT MEDICAL ATTENTION, AND WERE PRESCRIBED MEDICATION. ALL PATIENTS WERE REPORTED AS FULLY RECOVERED ALTHOUGH THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED DURING THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH PATIENT/ LENS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23985529 ↗
• 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 6 OF 7.

  Patient problems: Eye Infections

  MAUDE report 22342839 ↗
• MalfunctionDec 31, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048638 ↗
• MalfunctionJul 6, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE LENS WAS PREPARED ACCORDING TO THE INSTRUCTIONS. HOWEVER, A SICKLE-SHAPED PLASTIC PART WAS OBSERVED IN THE PATIENT'S EYE DURING IMPLANTATION OF THE LENS IN THE EYE, AND WAS ABLE TO BE RINSED OUT. EVENT DATE WAS AT THE END OF MAY. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS WAS IMPLANTED AND THERE WAS NO HARM TO THE PATIENT. THE PROBLEM WAS IDENTIFIED DURING AND AFTER IMPLANTATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125776 ↗