SMARTLOAD GCB00 (REF GCB0000240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474620681), received between Jul 2, 2021 and May 19, 2026 — classified as 1 injury, 9 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 10 most recent of 10 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 25225198 ↗
• 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 REPORT. THE OTHER FIVE (5) EVENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918255 ↗
• 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 REPORT. THE OTHER FIVE (5) EVENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918049 ↗
• 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 23917919 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED DURING INSERTION AND WAS NOT IMPLANTED. THE IOL WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662944 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED DURING INSERTION AND WAS NOT IMPLANTED. THE IOL WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662941 ↗
• MalfunctionJun 20, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BLOCKED IN THE TUNNEL. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS WAS STUCK IN THE CORNEAL TUNNEL, AND NO PROBLEMS WERE REPORTED WITH THE CARTRIDGE. THE FIRST IOL WAS REMOVED, AND A SECOND LENS WAS INSERTED WITHOUT ANY ISSUES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303147 ↗
• MalfunctionJun 9, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170402 ↗
• 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 4.

  Patient problems: Endophthalmitis

  MAUDE report 20919180 ↗
• MalfunctionJul 2, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. CUSTOMER HAS NOT PROVIDED ADDITIONAL DETAILS. NO PATIENT INJURY WAS REPORTED. MATERIAL IS AVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112518 ↗