SMARTLOAD GAB00 (REF GAB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474621763), received between Jul 11, 2024 and May 20, 2026 — 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.

• MalfunctionMay 20, 2026Crack; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS HAD BEEN DEFORMED AT THE TIP OF THE CARTRIDGE AND SHOWED SCRATCHES DURING HANDLING PRIOR TO INSERTION; THE LENS HAD NOT CONTACTED THE PATIENT¿S EYE, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231964 ↗
• MalfunctionAug 6, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW UP WE LEARNED THAT THE LOOP BROKE DURING IMPLANTATION. THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734005 ↗
• MalfunctionJun 9, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH DURING THE SURGICAL PROCEDURE. MST FORCEPS AND SCISSORS WERE USED TO CUT THE LENS, AND ANOTHER IOL WAS INSERTED. THERE WAS NO REPORT OF SERIOUS INJURY. THE VISCOELASTIC HAD BEEN OUT OF THE REFRIGERATOR FOR MORE THAN 30 MINUTES PRIOR TO THE SURGERY. THE PRODUCT IS NOT AVAILABLE FOR RETURN, AND NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173107 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT WHEN POSITIONING THE PRELOADED INTRAOCULAR LENS (IOL), AN OPTICAL DEFECT WAS NOTICED ON THE EDGE OF THE LENS. THE IOL WAS IMPLANTED AND REMAINS IN THE PATIENT'S EYE. ACCORDING TO THE CUSTOMER, THE LENS WAS LEFT IN THE EYE WITH NO PLAN TO BE REMOVED. THE PATIENT DOES NOT HAVE ANY SYMPTOMS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608030 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTATION WITH A PRELOADED INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) REQUIRED OTHER SURGICAL PROCEDURES; VISCOCANALOSTOMY AND SUPRACHOROIDAL DRAINAGE. ONE DAY POST SURGERY (ON 13 NOV 2021) THE PATIENT WAS DIAGNOSED WITH CONJUNCTIVAL HYPEREMIA, FOLDS IN DESCEMET'S MEMBRANE, CELLS IN ANTERIOR CHAMBER, OPTIC CUP TO DISC RATIO 7, AND MILD CHEMOSIS. THE INTRAOCULAR PRESSURE (IOP) READING WAS 03 MMHG, 12 MMHG FROM BASELINE. THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) READING WAS 0.10. ON NOVEMBER 19, 2021, DURING THE ONE WEEK POST-OPERATIVE VISIT, THE PATIENT PRESENTED WITH CONJUNCTIVAL HYPEREMIA, HYPHEMA AND REDUCED EYESIGHT DUE TO HYPHEMA. ON (B)(6)2022, DURING THE 6TH MONTH POST-OPERATIVE VISIT, THE PATIENT PRESENTED WITH OPTIC CUP TO DISC RATIO 7. IT WAS REPORTED THAT THERE WAS NO SECONDARY SURGICAL INTERVENTION PERFORMED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Chemosis; Eye Injury; Hyperemia; Hyphema; Inflammation

  MAUDE report 19726802 ↗