SMARTLOAD GAB00 (REF GAB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474621817), received between Jul 17, 2023 and Nov 14, 2025 — 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.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) COULD NOT BE CENTERED DUE TO ZONULOLYSIS (ZONULAR DEHISENCE). NO FURTHER DETAILS WERE PROVIDED.

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

  MAUDE report 23560437 ↗
• MalfunctionMay 19, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND IN THE ANTERIOR CHAMBER DURING INTRAOCULAR LENS (IOL) IMPLANTATION. ACCORDING TO THE CUSTOMER, THE PIECE WAS CLEARLY NOT FROM THE LENS AS THE IOL WAS IN PERFECT CONDITION. THE PLASTIC PIECE WAS REMOVED FROM THE ANTERIOR CHAMBER, AND THE SURGERY WAS COMPLETED AS PER THE ROUTINE. THE PATIENT HAD NO ADVERSE EFFECTS AND THERE WERE NO COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048883 ↗
• MalfunctionNov 1, 2023Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PROPERLY PLACED IN THE SHOOTER AND HANDLED NORMALLY; HOWEVER, WHEN ATTEMPTING TO IMPLANT, THE PLASTIC AT THE TIP OF THE CARTRIDGE SLIGHTLY CRUMBLED, MAKING FURTHER USE AND IMPLANTATION IMPOSSIBLE. IT IS NOT CLEAR IF IT WAS THE HANDLING OF THE CARTRIDGE OR PERHAPS THE SHOOTER THAT CAUSED THE PROBLEM. A NEW LENS FROM THE STOCK WAS IMPLANTED WITHOUT ANY ISSUES. NO FURTHER DETAILS WERE PROVIDED. THIS IS REPORT 2 OF 2. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER GAB00 UNIT WITH THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052397 ↗
• MalfunctionJul 17, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON HAD IMPLANTED A METAL PART INTO THE PATIENT'S EYE TOGETHER WITH THE INTRAOCULAR LENS (IOL). THE METAL PART WAS REMOVED. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS REMAINED IMPLANTED AND THAT THERE IS NO INDICATION OF ANY PATIENT ISSUES. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334753 ↗