SMARTLOAD GCB00 (REF GCB0000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474620629), received between Jan 30, 2024 and Jun 9, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 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 25451968 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS BENT IN HALF AND HAD A CUT IN THE MIDDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP IOL WITH NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115835 ↗
• MalfunctionApr 23, 2026Break

  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 24971902 ↗
• 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 23985307 ↗
• MalfunctionDec 15, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) GOT STUCK AND BROKE. THROUGH FOLLOW UP WE LEARNED THE CARTRIDGE TIP WAS IN CONTACT WITH THE PATIENT'S EYE. THE LENS GOT STUCK IN THE CARTRIDGE AND IT LIKELY THAT IS WHEN THE BREAKAGE OCCURRED. THERE IS NO MATERIAL AVAILABLE FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809612 ↗
• 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 5 OF 7.

  Patient problems: Eye Infections

  MAUDE report 22342828 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED WITH SOME MATERIAL MISSING IN THE CENTRAL AREA. IT WAS NECESSARY TO REPLACE THE IOL. ACCOUNT INDICATED THAT THE INCISION WAS ENLARGED IN THE PROCESS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21425686 ↗
• MalfunctionDec 26, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SMALL MARK ON THE EDGE OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) NEAR THE HAPTIC. THE LENS WAS FULLY INSERTED AND REMAINS IMPLANTED. THE PATIENT IS FINE AND HAS BEEN INFORMED ABOUT THE EVENT. THE PATIENT HAS NOT BEEN IN CONTACT WITH THE CLINIC SINCE. A REGULAR CHECK-UP IS SCHEDULED FOR 13TH JANUARY 2025. NO MATERIAL IS AVAILABLE FOR INVESTIGATION, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023504 ↗
• 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 5.

  Patient problems: Endophthalmitis

  MAUDE report 20919538 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND A BROKEN HAPTIC WHEN INSERTING INTRAOCULAR LENS (IOL) INTO THE EYE. IOL WAS REMOVED FROM THE EYE AND WAS REPLACED WITH ANOTHER MODEL (ZA9003) IOL. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869458 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT WHILE THE SURGEON WAS INJECTING A MONOFOCAL, INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THEY NOTICED A CRACK ON THE LENS. THE SURGEON THINKS THE INJECTOR WAS AT FAULT. THE INJECTOR THAT WAS USED WAS BRAND NEW AND HAD NOT BEEN USED BEFORE. THROUGH FOLLOW UP WE LEARNED THE FAULTY PRODUCT WAS REMOVED AND REPLACED IN THE SAME PROCEDURE AND NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONFIRMS THEY ARE UNSURE WHAT EXACTLY HAPPENED AND COULD NOT PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617265 ↗
• MalfunctionMar 19, 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 18938017 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT IMPLANTED. WE LEARNED THROUGH ADDITIONAL INFORMATION RECEIVED THAT THE LENS WAS DEFECTIVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610845 ↗