SMARTLOAD GCB00 (REF GCB0000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474620728), received between Oct 21, 2021 and Jan 23, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219568 ↗
• MalfunctionDec 31, 2024Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE WITH A VERY BENT, STRETCHED LEADING HAPTIC. THE LENS WAS IMPLANTED COMPLETELY AND WITHOUT DIFFICULTIES. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048536 ↗
• MalfunctionJul 19, 2022Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP IS DAMAGED. THROUGH FOLLOW-UP IT COULD NOT BE ESTABLISHED IF THERE HAD BEEN PATIENT CONTACT WITH THE UNIT OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053326 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) . ACCORDING TO THE CALCULATIONS THE TARGET WAS PLANO. NO COMPLICATIONS OR ANYTHING EXCEPTIONAL DURING THE PROCEDURE WAS NOTED, HOWEVER, DURING THE POST-OPERATIVE (OP) CHECK, A SURPRISE REFRACTION OF +4 WAS OBSERVED. THE SURGEON DECIDED TO EXPLANT THE LENS AND BASED ON POST-OP RESULTS, ANOTHER JOHNSON & JOHNSON A GCB00 26.0D LENS (SAME MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO COMPLICATIONS NOR EXCEPTIONS OCCURRED DURING THE EXPLANT PROCEDURE. IN POST-OP CHECK THE REFRACTION WAS NOTED AS -3,75. THE SURGEON DECIDED TO CHANGE THE LENS ONE MORE TIME. THE SECOND EXPLANT WAS DONE ON THE (B)(6) 2021 AND ANOTHER JOHNSON & JOHNSON A A GCB00 21.0D LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO COMPLICATIONS NOR EXCEPTIONS IN THE OPERATION NOTED AGAIN. ALL MATERIALS HAVE BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS HAD BEEN IMPLANTED INTO THE RIGHT EYE (OD) AND NO PATIENT ANATOMIES ISSUES WERE FOUND. THE INITIAL LENS LOOKED LIKE IT WAS SITTING NICELY CENTERED, BUT MAYBE LITTLE POSTERIORLY BEHIND THE IRIS LEVEL. NOW

  Patient problems: Visual Impairment

  MAUDE report 12734057 ↗
• MalfunctionOct 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) A SHORT FIBER WAS IDENTIFIED IN THE ANTERIOR CHAMBER. THE FIBER WAS ASPIRATED OUT DURING REMOVAL OF OVD (HEALON GV PRO). IT WAS REPORTED THAT THERE WAS NO EFFECT ON THE PATIENT AND NO NEED FOR EXTRA VISITS AT THIS POINT. THE PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED BY THIS ISSUE AND THE PATIENT HAS FULLY RECOVERED. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONALLY, IT WAS NOTED THAT THE FIBER IS NOT AVAILABLE, IT WAS ASPIRATED OUT OF THE EYE AND DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669965 ↗