SMARTLOAD GCB00 (REF GCB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474620650), received between Jul 5, 2022 and Jul 28, 2026 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Contamination

  It was reported that there was a piece of plastic sat on the Intraocular Lens (IOL) and entered the patient's eye with it. The piece of plastic was removed and it was intact. There was apparently nothing wrong with the IOL. Through follow-up, we learned, that the patient is fine and no additional treatment was required. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063486 ↗
• 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 25452004 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), DAMAGE TO THE OPTIC WAS DETECTED. THE IOL WAS REPLACED WITH A NEW ONE DURING THE SAME PROCEDURE. THERE WAS NO RESISTANCE IN THE INJECTOR DURING LOADING. ACCOUNT CONFIRMED THAT THE EVENT WAS FIRST IDENTIFIED AFTER IMPLANTATION. THE PROCEDURE WAS NOT SIGNIFICANTLY DELAYED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309918 ↗
• 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 23985319 ↗
• MalfunctionFeb 21, 2025Contamination; Mechanical Problem; Device Difficult to Setup or Prepare; Contamination; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT WHEN ADVANCING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FORWARD IN THE CARTRIDGE, IT BECAME A LITTLE HARDER THAN USUAL. THE INJECTOR PISTON WAS PUSHED PASSED THE BACK HAPTIC AND WAS STICKING OUT OF THE INCISION. THEN WHEN MANIPULATED CORRECTLY, AN L SHAPED PIECE OF PLASTIC WAS FOUND IN THE EYE. THE PIECE OF PLASTIC WAS REMOVED AND THE IOL OR HAPTIC WERE NOT DAMAGED. THROUGH FOLLOW UP, WE LEARNED THAT EXTRA TIME WAS REQUIRED INSPECTING AND LOOKING FOR ANY OTHER PLASTIC IN THE CAPSULE AND EXAMINING IF THE IOL HAD ANY DAMAGE. THE LENS REMAINS IMPLANTED AND THE PATIENT IS FINE. THROUGH FURTHER FOLLOW UP WE LEARNED THAT THE DELAY WAS 5-10 MINUTES MAXIMUM, WITH NO ISSUES TO REPORT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21436129 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CAME OUT WRONG. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION AND THE LENS WAS PARTIALLY INSERTED. THROUGH FOLLOW-UP WE LEARNED THAT THE FRONT HAPTIC CAME OUT TWISTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651275 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE IT WAS BROKEN. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438644 ↗
• MalfunctionDec 15, 2023Crack; Crack

  IT WAS REPORTED THAT THE INJECTOR WAS TWISTED AND THICKER, THE PRELOADED INTRAOCULAR LENS (IOL) WENT UNDERNEATH AND IT WAS IMPOSSIBLE TO IMPLANT IT. THE PATIENT WAS NOT AFFECTED. ANOTHER LENS OF THE SAME DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THROUGH FOLLOW-UP, WE LEARNED, THAT THE CARTRIDGE DAMAGE WAS DETECTED DURING IMPLANTATION. THE PHYSICIAN COULD NOT INSERT THE CARTRIDGE INTO THE INCISION AND THE IOL REMAINED OUTSIDE OF THE EYE. A PICTURE SHOWS ISSUE IS WITH THE TIP OF THE CARTRIDGE. ACCOUNT INDICATED THAT THE PATIENT IS PERFECTLY FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341354 ↗
• MalfunctionAug 3, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING INSERTION INTO THE PATIENT'S EYE, THE INTRAOCULAR LENS (IOL) CAME OUT OF THE INJECTOR WITHOUT ENTERING THE ANTERIOR CHAMBER; THEREFORE, THE IOL WAS NOT IMPLANTED. THROUGH FOLLOW UP WE LEARNED THAT THE UNIT WAS IN CONTACT WITH THE PATIENT'S EYE. THE ERROR OCCURRED DURING THE INJECTION/IMPLANTATION PHASE OF THE IOL INTO THE ANTERIOR CHAMBER. IT IS UNKNOWN EXACTLY WHAT OCCURRED; HOWEVER, AS PER THE CUSTOMER, IF THE CARTRIDGE IS NOT PROPERLY INSERTED INTO THE CORNEAL INCISION OR IF THE INCISION IS SLIGHTLY WIDER, THE THRUST PRESSURE CAUSES THE CARTRIDGE TO COME OUT OF THE EYE. CONSEQUENTLY, THE LENS IS HALF INSIDE THE TUNNEL AND HALF OUTSIDE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455577 ↗
• MalfunctionJun 27, 2023Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP BROKE AS THE INTRAOCULAR LENS (IOL) WAS PUSHED OUT DURING DELIVERY OF THE LENS. IOL FULLY IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213838 ↗
• MalfunctionJul 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS DEPLOYED, THERE WAS A SMALL PIECE OF PLASTIC IN THE ANTERIOR CHAMBER. IT WAS NOT CLEAR TO THE SURGEON IF IT WAS FROM THE IOL OR THE INJECTOR. IT WAS LEARNED THAT EVENTS LIKE THIS OCCURRED BEFORE AND THEY HAVE BEEN REPORTED TO US ALREADY CAPTURED IN OTHER COMPLAINT FOLDERS. IT WAS NOTED THAT ON ALL EVENTS, THE PIECES WERE REMOVED WITH SMALL FORCEPS. POSTOPERATIVELY, ALL HAD NORMAL FINDINGS. THE ORIGINAL VITAN SHOOTER WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14921092 ↗