SMARTLOAD GCB00 (REF GCB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474620674), received between Feb 8, 2021 and May 19, 2026 — classified as 1 injury, 12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Contamination

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON OBSERVED A BLACK FIBER IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED AND NO INTERVENTION WAS REQUIRED. THE SURGEON NOTED THAT THE PATIENT WAS FEMALE AND INDICATED THAT THE BLACK FIBER COULD BE MAKEUP NOT PROPERLY REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225141 ↗
• 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 ONE EVENT, THE OTHER FIVE (5) EVENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917924 ↗
• MalfunctionDec 13, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798693 ↗
• MalfunctionMay 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PACKAGE OF THE INTRAOCULAR LENS (IOL) WAS NOT SEALED WHEN THE BOX WAS OPENED. THROUGH FOLLOW-UP, WE LEARNED THAT THE CUSTOMER DOES NOT THINK IT WAS CAUSED BY SHIPPING BECAUSE THE OUTER BOX WAS INTACT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064330 ↗
• MalfunctionJul 22, 2024Contamination; Contamination

  IT WAS REPORTED THAT AFTER INSERTING THE PRELOADED INTRAOCULAR LENS (IOL), IT WAS DISCOVERED THAT THERE WAS A SMALL U SHAPED PIECE OF PLASTIC IN THE PATIENT'S EYE, WHICH HAD APPARENTLY COME OUT OF THE SHOOTER WITH THE LENS, POSSIBLY FROM THE CARTRIDGE. THE PATIENT IS NOT AFFECTED, THE SURGERY WENT AS PLANNED. THE PLASTIC PART WAS ASPIRATED OUT OF THE EYE, BUT IS NOT AVAILABLE FOR TESTING. THE CARTRIDGE IS AVAILABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798254 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196140 ↗
• MalfunctionMar 10, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING SURGERY A PIECE OF ANOTHER INTRAOCULAR LENS (IOL), APPEARING TO BE A DETACHED HAPTIC, WAS FOUND IN THE PATIENT'S EYE. THE SURGEON REMOVED IT WITHOUT ANY ISSUES. THE IOL REMAINS IMPLANTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INTERVENTIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523854 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Eye Injury

  MAUDE report 16500071 ↗
• MalfunctionJan 13, 2023Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE STUCK TO EACH OTHER WHEN PLACED WITHIN THE PATIENT'S OPERATIVE EYE. ACCOUNT INDICATED THAT THE HAPTICS WERE KISSING TIGHT. IT TOOK SEVERAL MINUTES TO MAKE THE IOL OPEN-UP. THROUGH FOLLOW UP WE LEARNED THAT ADDITIONAL MANEUVERS WERE NEEDED TO RELEASE THE HAPTICS. THE TOOL OLIVE BURATTO WAS USED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162396 ↗
• MalfunctionDec 15, 2022Break; Break

  IT WAS ORIGINALLY REPORTED THAT THE SMARTLOAD INTRAOCULAR LENS (IOL) WAS BROKEN AND IT WAS NOT IMPLANTED. THROUGH FOLLOW-UP WE LEARNED THAT THE IOL WAS IMPLANTED AND ONCE INSIDE THE EYE, THE SURGEON SAW THAT THE LENS WAS BROKEN. THE IOL WAS CUT AND REMOVED FROM THE PATIENT'S OPERATIVE EYE. ANOTHER LENS, SAME MODEL, WAS IMPLANTED WITHOUT ANY MAJOR DIFFICULTIES. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992884 ↗
• MalfunctionSep 28, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HAPTICS OF THE IOL (INTRAOCULAR LENS) WERE STUCK TO EACH OTHER. IT HAS TAKEN SEVERAL MINUTES TO SEPARATE THE HAPTICS. THROUGH FOLLOW UP WE LEARNED THAT THERE WAS NO HARM TO THE PATIENT AFTER THE IMPLANT OF THE LENS. THE IOL REQUIRED ADDITIONAL MANEUVERS TO POSITION THE LENS BECAUSE THE CUSTOMER HAD TO OPEN THE HAPTICS MANUALLY WITH THE HELP OF A SURGICAL INSTRUMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499572 ↗
• MalfunctionMay 17, 2021Break; Break

  IT WAS REPORTED THAT THE CUSTOMER SENT IN A FAX INDICATING THE LENS WAS UNSTERILE / DEFECTIVE. NO FURTHER DETAILS WERE GIVEN. PRODUCT INVESTIGATION WAS COMPLETED WITHOUT SAMPLE RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833689 ↗
• MalfunctionFeb 8, 2021Failure to Fold; Failure to Eject; Failure to Fold; Failure to Eject

  IT WAS REPORTED THAT THE TRAILING HAPTIC WAS STRAIGHT BEHIND THE LENS AND IT WAS STUCK BETWEEN CARTRIDGE TIP AND ROD. THE HAPTIC WAS MANIPULATED GENTLY AND RELEASED WITH SINSKEY HOOK INSTRUMENT. THE HAPTIC WAS PLACED IN THE BAG AND LENS CENTERED. NO EXTRA INTERVENTIONS NEEDED. THE LENS WAS FULLY INSERTED, THE PATIENT WAS DISCHARGED ACCORDING NORMAL PROTOCOL. NO POST OP. CHECK NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298826 ↗