SMARTLOAD GAB00 (REF GAB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474621824), received between Apr 22, 2021 and Mar 2, 2026 — classified as 4 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Contamination

  IT WAS REPORTED THAT FOREIGN PARTICLES, LIKELY PLASTIC, WERE OBSERVED EMERGING FROM THE CARTRIDGE. THE FOREIGN PARTICLES WERE DETECTED AND REMOVED AFTER THE PRELOADED INTRAOCULAR LENS (IOL) HAD BEEN IMPLANTED IN THE PATIENT'S EYE. NO ADVERSE EFFECTS OR CLINICAL COMPLICATIONS WERE OBSERVED. PATIENT FULLY RECOVERED WITHOUT SIGNIFICANT IMPACT ON DAILY ACTIVITIES. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE MINUTES, NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT NO CLINICALLY SIGNIFICANT ISSUES AFFECTING THE PATIENT WERE OBSERVED DURING THE POSTOPERATIVE DAY 1 AND WEEK 1 FOLLOW-UP EXAMINATIONS. NO OTHER ISSUES WERE OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492347 ↗
• MalfunctionJul 25, 2025Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CARTRIDGE WAS BROKEN. THE INCIDENT INVOLVED CONTACT WITH THE EYE; HOWEVER, ONLY THE CARTRIDGE CONTACTED THE EYE, NOT THE LENS. THERE WAS NO HARM TO THE PATIENT, AND A BACKUP LENS WAS USED. THE MATERIAL WAS RETURNED, AND THE INVESTIGATOR CONFIRMED THAT THE CRACK WAS AT THE TIP WITH NO INDICATION OF USER ERROR OR HANDLING ISSUES IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22611015 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE (OS) AND A MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE OPHTHALMIC VISCOSURGICAL DEVICE USED WAS FROM ANOTHER MANUFACTURER. NO SURGICAL COMPLICATIONS OCCURRED. ON (B)(6) 2021, THE PATIENT WAS EXAMINED AND PRESENTED AN INTRAOCULAR PRESSURE (IOP) OF 14 MMHG (1 MMHG FROM THE BASELINE). THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 0.32. THE FOLLOWING MEDICAL FINDINGS WERE OBSERVED: DRUSEN AND EPIRETINAL MEMBRANE. THE PATIENT CUP-TO-DISC RATIO WAS 4 AND THE PATIENT ALSO PRESENTED WITH RETINAL PIGMENT EPITHELIUM (RPE) CHANGES. ON (B)(6) 2022, DURING THE 6TH MONTH POST-OPERATIVE VISIT, THE PATIENT PRESENTED WITH AN IOP OF 15 MMHG (2 MMHG FROM THE BASELINE) AND A MANIFEST REFRACTION OF 1.0 -0.75 15°. THE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 0.10 AND THE PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA DURING THE CLINICAL EXAM. THE CUP-TO-DISC RATIO WAS 4. THE PATIENT WAS ADMINISTERED TRIAMCINOLONE DUE TO IRVINE GASS SYNDROME. ON (B)(6) 2022, DURING THE 12TH MONTH POS-OPERATIVE VISIT, THE PATIENT PRESENTED AND IOP OF 19 MMHG (6 MMHG FROM THE BASELINE). THE VALUES OF THE MANI

  Patient problems: Macular Edema

  MAUDE report 19753654 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE (OS) AND A MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED. OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM ANOTHER MANUFACTURER WAS USED TO PREPARE THE IOL AND NO SURGICAL COMPLICATIONS OCCURRED. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED: VISCOCANALOSTOMY, SUPRACHOROIDAL DRAINAGE AND OLOGEN IMPLANT. ON (B)(6) 2021, THE PATIENT WAS EXAMINED DURING A POST-OPERATIVE VISIT AND PRESENTED AN INTRAOCULAR PRESSURE (IOP) OF 5 MMHG (-19MMHG FROM THE BASELINE). THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) EVALUATED WAS HAND MOVEMENT AND THE PATIENT WAS DIAGNOSED WITH CONJUNCTIVAL HYPEREMIA/INJECTION AND DRY EYE/SUPERFICIAL PUNCTATE KERATOPATHY/PUNCTATE EPITHELIAL EROSION/TEAR FILM INSUFFICIENCY. THE SLIT LAMP SHOWED THE PATIENT PRESENTED WITH HYPHEMA. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT IS FULLY RECOVERED. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hyphema

  MAUDE report 19752736 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY ON (B)(6) 2021 FOR THE RIGHT EYE (OD) AND IT WAS IMPLANTED WITH A MONOFOCAL INTRAOCULAR LENS (IOL). THE IOL WAS PREPARED WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM ANOTHER MANUFACTURER. NO SURGICAL COMPLICATIONS WERE REPORTED. ON (B)(6) 2012 THE PATIENT WAS EXAMINED (DAY 1 POST-OPERATIVE) AND PRESENTED AN INTRAOCULAR PRESSURE (IOP) OF 16MMHG (-7 MMHG FROM THE BASELINE). THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 1.00 AND THE PATIENT PRESENTED RETINAL PIGMENT EPITHELIUM (RPE) CHANGES. ON (B)(6) 2021, DURING THE ONE WEEK POST-OPERATIVE VISIT, THE PATIENT PRESENTED AN IOP OF 36 MMHG (13MMHG FROM THE BASELINE), A MANIFEST REFRACTION OF 0.75 -1.5 92°. THE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 1.00. THE PATIENT WAS DIAGNOSED WITH ELEVATED INCREASED INTRAOCULAR PRESSURE (IOP)/OCULAR HYPERTENSION AND STILL PRESENTED RPE CHANGES. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 AND THE FOLLOWING MEDICATIONS WERE ADMINISTERED: ALPHAGAN AND DIAMOX. ON (B)(6) 2022, DURING THE 6TH MONTH POST-OPERATIVE VISIT, THE PATIENT PRESENTED AN IOP OF 25MMHG (2 MMHG FROM THE BASELINE), A MANIFEST REFRACTION OF 1.0 -2 84° AND A

  Patient problems: Intraocular Pressure Increased; Posterior Capsule Opacification

  MAUDE report 19745877 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CASE OF POST-OPERATIVE ENDOPHTHALMITIS. THE DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED AND A VITRECTOMY WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 11710954 ↗