SMARTLOAD GAB00 (REF GAB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474621848), received between Oct 16, 2021 and Aug 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Break; Device Difficult to Setup or Prepare; Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311643 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A BREAKAGE OF THE CARTRIDGE WAS OBSERVED RESULTING IN THE BREAKAGE OF THE LENS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860603 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING THE ADVANCEMENT OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE CARTRIDGE, THE LENS BROKE AT SOME POINTS ON THE PLATE AND HAPTIC, SO IT WAS REPLACED WITH ANOTHER LENS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042724 ↗
• MalfunctionJul 18, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON THE BODY OF THE INTRAOCULAR LENS (IOL). NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347493 ↗
• MalfunctionJun 6, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE INJECTOR. A BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE INJECTOR DID NOT PUSH THE PRELOADED INTRAOCULAR LENS (IOL) OUT OF THE SMARTLOAD DEVICE. INSTEAD, THE INJECTOR CRUMPLED THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605530 ↗
• MalfunctionOct 16, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE CUSTOMER NOTICED A SMALL FRACTURE WHILE THE LENS WAS STILL IN THE SHOOTER. ACCORDING TO THE CUSTOMER, THERE WAS NO CONTACT WITH THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643788 ↗