SMARTLOAD GAB00 (REF GAB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474621770), received between Jun 20, 2025 and May 21, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMay 21, 2026Contamination

  IT WAS REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A FOREIGN BODY WAS OBSERVED INSIDE THE PATIENT¿S EYE. THE FOREIGN BODY WAS FOUND TO HAVE ORIGINATED FROM THE DEVICE USED TO IMPLANT THE IOL. THE FOREIGN BODY WAS REMOVED FROM THE EYE, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED, AND THERE WAS NO DELAY IN THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249448 ↗
• MalfunctionMar 2, 2026Contamination

  IT WAS REPORTED THAT FOREIGN PARTICLES, LIKELY PLASTIC, WERE OBSERVED EMERGING FROM THE CARTRIDGE. THE FOREIGN PARTICLES WERE DETECTED AND REMOVED AFTER THE PRELOADED INTRAOCULAR LENS (IOL) HAD BEEN IMPLANTED IN THE PATIENT'S EYE. NO ADVERSE EFFECTS OR CLINICAL COMPLICATIONS WERE OBSERVED. PATIENT FULLY RECOVERED WITHOUT SIGNIFICANT IMPACT ON DAILY ACTIVITIES. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE MINUTES, NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT NO CLINICALLY SIGNIFICANT ISSUES AFFECTING THE PATIENT WERE OBSERVED DURING THE POSTOPERATIVE DAY 1 AND WEEK 1 FOLLOW-UP EXAMINATIONS. NO OTHER ISSUES WERE OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492351 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE BROKE, RESULTING IN A LOOP BREAKAGE. THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733986 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SLIPPED INTO THE BACK OF THE EYE DURING IMPLANTATION. PARS PLANA VITRECTOMY (PPV) WAS PERFORMED FOR RETRIEVAL OF THE IOL. NO FURTHER DETAILS WERE PROVIDED.

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

  MAUDE report 22302984 ↗