SMARTLOAD GAB00 (REF GAB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474621855), received between May 26, 2023 and Dec 22, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THE SURGEON OBSERVED A THREAD WITHIN THE LENS MATERIAL AT THE 11 O¿CLOCK POSITION, WHICH WAS NOT IDENTIFIED AS A CORTEX THREAD OR A SCRATCH, BUT A THREAD THAT IS INSIDE THE MATERIAL. THE LENS REMAINS IMPLANTED. THROUGH FOLLOW UPS, WE LEARNED THAT THE IOL WAS IMPLANTED THROUGH A COMPLETELY NORMAL PHACOEMULSIFICATION PROCEDURE. NO LENS EXCHANGE IS PLANNED. ACCOUNT INDICATED THAT THE IOL IMPLANTATION OF THE OTHER EYE (RIGHT) TOOK PLACE ON (B)(6) 2025, DURING WHICH VISUAL ACUITY OF THE LEFT EYE WAS MEASURED AS 0.8 WITH NO COMPLAINTS FROM THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874265 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CAPSULE RUPTURE FOLLOWING IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE LENS WAS REMOVED FROM THE EYE AND A SULCOFLEX IOL WAS IMPLANTED INSTEAD. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23855778 ↗
• MalfunctionMay 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON INTRODUCED A METAL PARTICLE INTO THE PATIENT'S EYE WHEN IMPLANTING AN INTRAOCULAR LENS (IOL). THE PARTICLE WAS REMOVED AND IS AVAILABLE FOR PRODUCT INVESTIGATION. WE LEARNED THROUGH FOLLOW UP THAT THE IOL REMAINS IMPLANTED AND THAT THERE IS NO MORE INFORMATION ON HOW THE PATIENT IS DOING NOW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015182 ↗