SMARTLOAD GCB00 (REF GCB0000200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474620605), received between Apr 23, 2019 and Dec 29, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT, ON A COUPLE OF OCCASIONS, THE SURGEON OBSERVED THAT A LENS APPEARED ¿FURRY¿ WHEN VIEWED UNDER A MICROSCOPE DURING PROCEDURES. THIS ISSUE WAS NOT VISIBLE TO THE SCRUB NURSE BUT WAS CLEARLY SEEN BY THE SURGEON UNDER THE MICROSCOPE. THROUGH FOLLOW UP WE LEARNED THERE WERE 6 OCCASIONS OF THIS ISSUE ALL OBSERVED ON THE SAME DAY. THE SURGEON BELIEVES THE IOLS WERE NOT POLISHED AND THE ISSUE WAS ONLY LOCATED ON THE EDGE OF THE OPTICS. NO PATIENT HARM OR ADVERSE OUTCOMES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES 1 EVENT. THE OTHER FIVE (5) EVENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917879 ↗
• MalfunctionOct 15, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), A SCRATCH WAS NOTICED ON THE LENS. THE EMPLOYEE HAD FILLED OPTICEL AND BALANCED SALT SOLUTION (BSS) INTO THE INJECTOR AND ADVANCED THE IOL WITHOUT ISSUES. HOWEVER, DURING IMPLANTATION, THE SECOND HAPTIC IN THE INJECTOR BECAME STUCK AND TWISTED, RESULTING IN A SCRATCH ON THE OPTICS IN THE MIDDLE PERIPHERY. THROUGH FOLLOW UP, WE LEARNED THAT THE LENS REMAINS IMPLANTED. THE PATIENT IS NOT EXPERIENCING ANY ISSUES. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286645 ↗
• 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 4 OF 7.

  Patient problems: Eye Infections

  MAUDE report 22342825 ↗
• MalfunctionMar 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHEN THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED, A PLASTIC PIECE WAS FOUND ATTACHED TO THE TIP OF THE CARTRIDGE. THERE WAS NO DAMAGE TO THE IOL. THE PROCEDURE WAS DELAYED. THE PATIENT WAS NOT HARMED AND WAS REPORTED AS FULLY RECOVERED. THROUGH FOLLOW UP, WE LEARNED THAT THE DELAY WAS NOT SIGNIFICANT. THE SURGEON CHECKED THAT NO PLASTIC PARTICLE WAS LEFT IN THE PATIENT¿S EYE. PRODUCT IS BEING RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540588 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON NOTICED A HALF MILLIMETER CRACKLING ON THE OPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE ISSUE WAS IDENTIFIED DURING THE IMPLANTATION PROCESS. ACCOUNT INDICATED THAT THE LENS WAS FULLY INSERTED. THERE ARE NO PLANS TO EXPLANT THE IOL UNLESS THE PATIENT HAS COMPLICATIONS. REPORTEDLY, EVERYTHING IS FINE WITH THE PATIENT SO FAR. THE PATIENT IS BEING MONITORED. THERE IS NO MATERIAL AVAILABLE FOR FURTHER INVESTIGATION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246128 ↗
• MalfunctionJan 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT AN INCIDENT OCCURRED DURING A CATARACT SURGERY INVOLVING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). AFTER THE LENS WAS FULLY INSERTED, THE SURGEON OBSERVED A THREAD WITHIN THE EYE, WHICH WAS SUBSEQUENTLY REMOVED USING THE IRRIGATION/ASPIRATION (IA) HANDPIECE. FORTUNATELY, THERE WERE NO COMPLICATIONS DURING OR AFTER THE SURGERY. THE PATIENT INVOLVED HAS FULLY RECOVERED, AND THEIR DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THROUGH FOLLOW-UP WE LEARNED THAT THE IOL REMAINS IMPLANTED, AND THERE IS NO MATERIAL AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213326 ↗
• 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 18610846 ↗
• MalfunctionOct 10, 2023Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) INSERTION, THE SURGEON DISCOVERED THAT THE HAPTICS WERE STICKING TOGETHER AND IT WAS DIFFICULT TO SEPARATE THEM. THIS WAS OBSERVED WITH A TOTAL OF THREE (3) OUT OF TWELVE (12) CASES OF THE DAY. THE PHYSICIAN PREPARED THE IOL ACCORDING TO THE DIRECTIONS FOR USE (DFU). THROUGH FOLLOW-UP WE LEARNED THAT THE IOLS WERE STORED ACCORDING TO THE DFU. THE UNFOLDING OF THE LENS REQUIRED EXTRA MANEUVERS AND INSTRUMENTS THAT WERE USED TO PUSH AND SEPARATE THE HAPTICS APART. THE PATIENT IS DOING GOOD. PATIENT CONDITIONS WERE NOT AFFECTED, EXCEPT FOR A SLIGHT DELAY DUE TO USE OF EXTRA INSTRUMENTS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE LENSES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909496 ↗
• MalfunctionOct 24, 2022Contamination; Contamination

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED INTRAOCULAR LENS (IOL), A RING WAS FOUND IN THE EYE AND WAS REMOVED WITHOUT ANY CONSEQUENCES TO THE OUTCOME OF THE SURGERY. THE OPERATING THEATER STAFF DID NOT KEEP EITHER THE RING OR THE CARTRIDGE. THROUGH FOLLOW UP IT WAS VERIFIED THAT THE FOREIGN MATERIAL WAS INTRODUCED INTO THE EYE AND REMOVED IMMEDIATELY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664181 ↗
• MalfunctionOct 15, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LENS WAS IMPLANTED NORMALLY. AFTER THE IMPLANTATION TWO SCRATCHES WERE FOUND ON THE LENS. NO INTERVENTIONS ARE REQUIRED, AS THE SCRATCHES ARE ONLY ON THE EDGE OF THE LENS OPTICS. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612475 ↗
• MalfunctionOct 1, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS MOVING WITH DIFFICULTY IN THE CARTRIDGE AND WHEN PREPARING IT FOR THE IMPLANT IT DID NOT WORK WELL AND A NOTCH WAS MADE IN THE OPTIC. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566190 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF THE INTRAOCULAR LENS INTO THE PATIENT¿S LEFT EYE, INTRAOCULAR PRESSURE (IOP) SPIKED AT THE 1-DAY POST-OP VISIT. REPORTEDLY THERE WAS PATIENT COMPLICATION AND/OR RELATED INJURY, IOP SPIKE REQUIRING TREATMENT WAS NOT SIGHT THREATENING. THE LENS CURRENTLY REMAINS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT IS TAKING DIAMOX TO REDUCE THE IOP. SURGEON USES A WOUND ASSISTED TECHNIQUE FOR IMPLANTATION BUT DURING IMPLANTATION THE IOL POPPED FROM WOUND AND WAS ASSISTED IN TO THE ANTERIOR CHAMBER (AC) DURING INSERTION. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 8542087 ↗