SMARTLOAD GCB00 (REF GCB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474620599), received between May 23, 2019 and Apr 17, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Fragmentation; Scratched Material

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A FRAGMENT WAS RELEASED IMMEDIATELY AFTER IMPLANTATION AND WAS LOCATED AT THE BOTTOM NEXT TO THE HAPTIC. A SMALL CHIP WAS NOTED TO BE MISSING FROM THE EDGE OF THE OPTIC AT THE 2 O¿CLOCK POSITION, AND THE RELEASED FRAGMENT WAS DESCRIBED AS NOTICEABLY LARGER THAN THE MISSING CHIP. THE EVENT WAS IDENTIFIED AFTER IMPLANTATION, AND THERE WERE NO REPORTED PATIENT INJURIES. THE PATIENT¿S STATUS WAS REPORTED AS FULLY RECOVERED. THERE WAS NO SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE. THE FRAGMENT WAS REMOVED FROM THE EYE DURING THE PROCEDURE, AND THE IOL WAS FULLY IMPLANTED AS INTENDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918563 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED. THROUGH FOLLOW UP, WE LEARNED THAT THE PROXIMAL HAPTIC WAS BROKEN. THE IOL WAS REPLACED WITH ANOTHER ONE DURING THE SAME PROCEDURE. THE LENS WAS DISCARDED UPON REMOVAL. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064434 ↗
• 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 3.

  Patient problems: Endophthalmitis

  MAUDE report 20920631 ↗
• MalfunctionOct 15, 2024Crack; Crack

  IT WAS REPORTED THAT THE NURSE PLACED THE CARTRIDGE INTO THE INJECTOR. AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE, THE DOCTOR SAW A BURR ON THE TIP OF THE CARTRIDGE. LENS WAS FULLY INSERTED AND REMAINS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED AND THE ISSUE WAS IDENTIFIED AFTER PRODUCT USE. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453439 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED DUE TO A FAULTY INJECTOR. ACCOUNT INDICATED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO MATERIAL IS AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263392 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT WHEN USING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE DOCTOR WAS ABOUT TO INSERT THE IOL INTO THE INSERTER, HE PULLED TOO HARD CAUSING ONE OF THE HAPTICS TO BREAK. AS A RESULT, THE LENS WAS NOT INSERTED INTO THE PATIENT'S EYE; A DIFFERENT LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041931 ↗
• MalfunctionApr 29, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S EYE. ACCOUNT INDICATED THAT THE SURGEON NOTICED AN OPACIFICATION IN THE LENS WHEN PLACING THE LENS IN THE CAPSULAR BAG. THE LENS WAS CUT IN TWO AND EXPLANTED. THE PATIENT IS REPORTED AS FULLY RECOVERED. WE LEARNED THROUGH FOLLOW UP THAT THE REMOVED LENS, WAS REPLACED DURING THE INITIAL PROCEDURE WITH A LENS OF THE SAME MODEL AND DIOPTER. THE IOL WAS DISCARDED UPON REMOVAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19208628 ↗
• MalfunctionMar 23, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966053 ↗
• MalfunctionOct 23, 2023Crack; Crack

  IT WAS REPORTED THAT AFTER IMPLANTATION THE SURGEON DISCOVERED THAT THE TIP OF THE CARTRIDGE WAS CRACKED ALONG THE TIP. THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED WITHOUT ANY DAMAGE AND THE PATIENT WAS NOT AFFECTED BY IT. NO MEDICAL INTERVENTION WAS REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987260 ↗
• MalfunctionJan 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BAG IN WHICH THE LENS IS LOCATED DID NOT LOOK CLOSED, SO ANOTHER LENS WAS USED. THERE WAS NO CONTACT WITH THE PATIENTS EYE AS THE ISSUE WAS FIRST IDENTIFIED UPON OPENING OF THE PACKAGING. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE BAG WAS PARTIALLY OPENED. THE BAG WAS NOT PROPERLY SEAL AROUND THE PACKAGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13186217 ↗
• MalfunctionJul 17, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING A SURGERY, THE PLUNGER OF A PRELOADED LENS, PUSHED OVER THE LENS BUT SURGEON WAS STILL ABLE TO PUSH IT FORWARD. LENS WAS IMPLANTED WITHOUT ANY PROBLEM. HOWEVER A SMALL PLASTIC RING/PIECE, WHICH SEEMS TO CAME FROM THE CARTRIDGE, WAS ALSO INJECTED INTO THE PATIENT'S EYE, THAT WAS DIRECTLY REMOVED. NO INJURY FOR THE PATIENT AT POST-OP VISIT. ALL THE AVAILABLE INFORMATION WERE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292277 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN SPIKE IN INTRAOCULAR PRESSURE (IOP) IN THE PATIENT¿S RIGHT EYE ONE DAY POST IMPLANT OF A MONOFOCAL INTRAOCULAR LENS (IOL). THE PATIENT WAS TREATED WITH DIAMOX. THE EVENT WAS CONSIDERED NOT SIGHT THREATENING. THERE WAS NO PATIENT COMPLICATION OR RELATED INJURY REPORTED. PATIENT STATUS IS REPORTED AS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 8638660 ↗