SMARTLOAD GAB00 (REF GAB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474621732), received between Jan 25, 2024 and Jun 27, 2025 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352384 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE (OD) AND THE MONOFOCAL INTRAOCULAR LENS (IOL) 17.5D WAS IMPLANTED. THE IOL WAS PREPARED WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM ANOTHER MANUFACTURER. DURING SURGERY AN HEMORRHAGE DUE TO CANALOPLASTY OCCURRED AND A DEEP SCLEROTOMY/SUTURE CANALOPLASTY SUPRACHOROIDAL DRAINAGE WAS PERFORMED AND AN OLOGEN IMPLANT (6 MM) WAS PLACED. THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2022, THE PATIENT WAS EXAMINED AND PRESENTED AN INTRAOCULAR PRESSURE (IOP) OF 2 MMHG (-22 MMHG FROM THE BASELINE). THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS HAND MOVEMENT. THE PATIENT PRESENTED WITH CORNEAL EDEMA, FOLDS IN DESCEMET'S AND HYPHEMA. THE PATIENT WAS ALSO DIAGNOSED WITH CONJUCTIVA CHEMOSIS AND STRESS FOLDS. ON (B)(6) 2022 THE PATIENT WAS EXAMINED AND PRESENTED AN IOP OF 5 MMHG (-19 MMHG FROM THE BASELINE). THE PATIENT ALSO PRESENTED WITH CONJUNCTIVAL HYPEREMIA/INJECTION AND HYPHEMA PERSISTED. THE PATIENT WAS DISCHARGED. THE HYPHEMA WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2022. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Hyphema; Unspecified Eye / Vision Problem

  MAUDE report 19746885 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE (OS) AND THE MONOFOCAL INTRAOCULAR LENS (IOL) 17.5D WAS IMPLANTED. THE IOL WAS PREPARED WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM ANOTHER MANUFACTURER. NO SURGICAL COMPLICATIONS OCCURRED. THE FOLLOWING WAS PERFORMED A SUTURE CANALOPASTY, A SUPRACHOROIDAL DRAINAGE, OLOGEN IMPLANT (6MM). THE PATIENT WAS HOSPITALIZED. ON FEBRUARY 8, 2022 THE PATIENT WAS EXAMINED AND PRESENTED AN INTRAOCULAR PRESSURE (IOP) OF 12 MMHG (-7 MMHG FROM THE BASELINE). THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS HAND MOVEMENT. THE PATIENT ALSO PRESENTED CONJUCTIVAL HYPEREMIA/INJECTION AND DRY EYE/SUPERFICIAL PUNCTATE KERATOPATHY/PUNCTATE EPITHELIAL EROSION/TEAR FILM INSUFFICIENCY; AND CELLS IN THE ANTERIOR CHAMBER. THE PATIENT ALSO PRESENTED AN IRIS BASE TEAR. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. THE HYPHEMA RESOLVED WITHOUT SEQUELAE. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); Hyperemia; Hyphema; Inflammation; Unspecified Eye / Vision Problem

  MAUDE report 19746879 ↗
• MalfunctionJan 25, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED BY THE SHOOTER DURING IMPLANTATION. A NEW LENS WITH THE SAME DIOPTER WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581724 ↗