SMARTLOAD GCB00 (REF GCB0000250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474620704), received between Mar 26, 2024 and Jun 9, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 25451880 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED DURING INSERTION; THEREFORE, THE IOL WAS NOT IMPLANTED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689230 ↗
• MalfunctionJul 25, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22611934 ↗
• MalfunctionJun 18, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564098 ↗
• MalfunctionMar 26, 2024Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A SMALL PIECE OF "STEEL WIRE" FOLLOWED THE LENS INTO THE EYE. ACCOUNT INDICATED THAT THE LENS WAS NOT DAMAGED AND THE FOREIGN MATERIAL WAS REMOVED WITH TWEEZERS. THE EYE WAS NOT AFFECTED AND THE PATIENT WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983743 ↗