SMARTLOAD GCB00 (REF GCB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474620643), received between Dec 9, 2022 and Jun 5, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) COULD NOT BE SQUEEZED OUT OF THE CARTRIDGE AS IT APPEARED CROOKED OR STUCK. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE ISSUE WAS DISCOVERED DURING PREPARATION PRIOR TO USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410876 ↗
• MalfunctionDec 29, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT, ON A COUPLE OF OCCASIONS, THE SURGEON OBSERVED THAT A LENS APPEARED ¿FURRY¿ WHEN VIEWED UNDER A MICROSCOPE DURING PROCEDURES. THIS ISSUE WAS NOT VISIBLE TO THE SCRUB NURSE BUT WAS CLEARLY SEEN BY THE SURGEON UNDER THE MICROSCOPE. THROUGH FOLLOW UP WE LEARNED THERE WERE 6 OCCASIONS OF THIS ISSUE ALL OBSERVED ON THE SAME DAY. THE SURGEON BELIEVES THE IOLS WERE NOT POLISHED AND THE ISSUE WAS ONLY LOCATED ON THE EDGE OF THE OPTICS. NO PATIENT HARM OR ADVERSE OUTCOMES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES IN ONE EVENT. THE OTHER FIVE (5) EVENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917966 ↗
• MalfunctionOct 27, 2025Contamination; Contamination

  IT WAS REPORTED THAT A BLACK FIBER WAS OBSERVED IN THE PATIENT'S EYE POST IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL). THE SURGEON REMOVED THE FIBER USING FORCEPS, AND THE REMAINDER OF THE SURGERY PROCEEDED WITHOUT ISSUES. THERE WERE NO REPORTS OF PATIENT HARM. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT NO INTERVENTIONS WERE REQUIRED. THE DIRECTIONS FOR USE WERE FOLLOWED BY THE SURGEON AND NO RESISTANCE WAS OBSERVED DURING LENS INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399199 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED. AFTER THE IMPLANTATION, THE SURGEON IDENTIFIED THAT ONE OF THE HAPTICS ON THE IOL WAS FRACTURED OR FAULTY. CONSEQUENTLY, THE LENS WAS REMOVED, CUT, AND REPLACED WITH THE SAME MODEL OF IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045658 ↗
• MalfunctionAug 10, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768178 ↗
• MalfunctionJan 17, 2025Contamination; Delivered as Unsterile Product; Contamination; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SCRUB NURSE NOTICED FIBER-LIKE MATERIAL INSIDE THE STERILE PACKAGE OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WHILE PREPARING IT FOR IMPLANTATION. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT; THEREFORE, THERE WAS NO IMPACT ON THE PATIENT. AN ASSISTANT NURSE OPENED A SECOND LENS, WHICH WAS IMPLANTED WITHOUT ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185576 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERIES, 6 OF 11 PATIENTS NOW RECEIVE TREATMENT IN THE HOSPITAL. BACTERIAL INFECTION IS SUSPECTED. PATIENT NUMBER 6 HAD BOTH EYES TREATED. THE CLINIC USED A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FOR THESE PATIENTS, BUT THE SURGEON DOES NOT EXPECT THE IOLS TO BE THE SOURCE OF THE INFECTION. ALL OTHER EQUIPMENT USED FOR THE PROCEDURES WERE FROM OTHER SUPPLIERS. ACCOUNT INDICATED THAT THE OTHER 5 PATIENTS ARE WELL (PATIENTS WITHOUT THE INFECTION POST SURGERY). IT WAS ALSO CONFIRMED THAT ALL SURGERIES TOOK PLACE ON THE SAME DATE. OVERNIGHT HOSPITAL STAY AND MEDICAL INTERVENTIONS WERE REQUIRED. PATIENTS HAVE BEEN DIAGNOSED WITH ENDOPHTHALMITIS. NO SOURCE OF THE INFECTION HAS BEEN FOUND YET AS PER IN-HOUSE INVESTIGATION. THERE IS NO FURTHER PATIENT OUTCOME INFORMATION. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED. NOTE SEPARATE COMPLAINTS HAVE BEEN CREATED FOR EACH OF THE 6 PATIENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 6'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THIS PATIENT'S LEFT EYE (OS).

  Patient problems: Endophthalmitis

  MAUDE report 20921564 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERIES, 6 OF 11 PATIENTS NOW RECEIVE TREATMENT IN THE HOSPITAL. BACTERIAL INFECTION IS SUSPECTED. PATIENT NUMBER 6 HAD BOTH EYES TREATED. THE CLINIC USED A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FOR THESE PATIENTS, BUT THE SURGEON DOES NOT EXPECT THE IOLS TO BE THE SOURCE OF THE INFECTION. ALL OTHER EQUIPMENT USED FOR THE PROCEDURES WERE FROM OTHER SUPPLIERS. ACCOUNT INDICATED THAT THE OTHER 5 PATIENTS ARE WELL (PATIENTS WITHOUT THE INFECTION POST SURGERY). IT WAS ALSO CONFIRMED THAT ALL SURGERIES TOOK PLACE ON THE SAME DATE. OVERNIGHT HOSPITAL STAY AND MEDICAL INTERVENTIONS WERE REQUIRED. PATIENTS HAVE BEEN DIAGNOSED WITH ENDOPHTHALMITIS. NO SOURCE OF THE INFECTION HAS BEEN FOUND YET AS PER IN-HOUSE INVESTIGATION. THERE IS NO FURTHER PATIENT OUTCOME INFORMATION. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED. NOTE SEPARATE COMPLAINTS HAVE BEEN CREATED FOR EACH OF THE 6 PATIENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 6'S LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THIS PATIENT'S RIGHT EYE (OD).

  Patient problems: Endophthalmitis

  MAUDE report 20920771 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FACING BACKWARDS. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AS THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499819 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FACING BACKWARDS. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AS THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498470 ↗
• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE IT WAS DAMAGED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483488 ↗
• MalfunctionOct 10, 2023Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) INSERTION, THE SURGEON DISCOVERED THAT THE HAPTICS WERE STICKING TOGETHER AND IT WAS DIFFICULT TO SEPARATE THEM. THIS WAS OBSERVED WITH A TOTAL OF THREE (3) OUT OF TWELVE (12) CASES OF THE DAY. THE PHYSICIAN PREPARED THE IOL ACCORDING TO THE DIRECTIONS FOR USE (DFU). THROUGH FOLLOW-UP WE LEARNED THAT THE IOLS WERE STORED ACCORDING TO THE DFU. THE UNFOLDING OF THE LENS REQUIRED EXTRA MANEUVERS AND INSTRUMENTS THAT WERE USED TO PUSH AND SEPARATE THE HAPTICS APART. THE PATIENT IS DOING GOOD. PATIENT CONDITIONS WERE NOT AFFECTED, EXCEPT FOR A SLIGHT DELAY DUE TO USE OF EXTRA INSTRUMENTS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE LENSES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909768 ↗
• MalfunctionOct 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER INSERTION OF THE MONOFOCAL INTRAOCULAR LENS (IOL) THE HAPTICS WERE STICKING TOGETHER AND THE SURGEON NEEDED A SECOND INSTRUMENT TO SEPARATE THEM. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909306 ↗
• MalfunctionJan 13, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN UNKNOWN WHITE COLORED PARTICLE APPEARED STUCK TO THE EDGE OF THE OPTIC AFTER INTRAOCULAR LENS (IOL) IMPLANTATION INTO THE CAPSULAR BAG. THE SURGEON MANAGED TO EASILY REMOVE THE MATTER USING THEIR PHACO HANDPIECE. ACCOUNT INDICATED THAT THE SURGERY DID NOT APPEAR TO BE AFFECTED APART FROM A SHORT DELAY, ONE MINUTE. DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS POST SURGERY IS UNKNOWN. NO MEDICAL OR SURGICAL INTERVENTIONS WERE MENTIONED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164339 ↗
• MalfunctionDec 9, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THERE WAS SMALL, CLEAR PIECE OF PLASTIC IN FRONT OF THE LENS. THE PIECE WAS REMOVED WITH FORCEPS WITHOUT ISSUES AND THE PATIENT DID NOT REQUIRE ANY FURTHER TREATMENTS. THE PATIENT WILL BE CHECKED WHEN THE 2ND EYE WILL BE OPERATED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955407 ↗