SMARTLOAD GCB00 (REF GCB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474620636), received between May 18, 2022 and Sep 17, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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.

• MalfunctionSep 17, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797052 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25843174 ↗
• MalfunctionNov 5, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE AN INCLUSION IN THE OPTIC. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482219 ↗
• MalfunctionApr 30, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A SMALL PIECE OF PLASTIC FOLLOWED THE LENS INTO THE PATIENT'S EYE. THE IOL ITSELF WAS NOT DAMAGED, AND THE PLASTIC WAS SUCCESSFULLY REMOVED. THE PATIENT'S EYE WAS NOT AFFECTED BY THIS INCIDENT. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, WE LEARNED THAT THERE IS NO MATERIAL AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937021 ↗
• MalfunctionMar 12, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THROUGH A 2.2 MM INCISION, RESULTING IN HALF OF THE LENS REMAINING OUTSIDE THE EYE. THE SURGEON OPTED TO REMOVE THE IOL AND CREATE A LARGER INCISION TO IMPLANT A NEW LENS. THROUGH FOLLOW UP, WE LEARNED THAT NO SUTURES WERE REQUIRED, THE PROCEDURE WAS ONLY DELAYED BY 1-2 MINUTES. NO COMPLICATIONS WERE NOTICED DURING THE IMPLANTATION. THE PATIENT WAS FINE WHEN LEAVING THE HOSPITAL, WITH NO FURTHER CHECK UPS SCHEDULED. THE CARTRIDGE AND IOL ARE NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21589847 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FAULTY. THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT COME OUT INTACT. FURTHER FOLLOW UP REVEALED THAT THE LENS DID NOT COME OUT AT ALL AND THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ANOTHER LENS WAS USED INSTEAD AND THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153225 ↗
• MalfunctionMar 23, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THREE SMALL SPOTS (SCRATCHES) ON THE LENS SURFACE AFTER IT WAS IMPLANTED. THE SCRATCHES ARE NOT IN THE OPTICAL AXIS AND THERE WAS NO NEED TO EXPLANT OR PERFORM ANY OTHER INTERVENTION. PATIENT IS BEING MONITORED. THROUGH FOLLOW UP WE LEARNED THAT THE DIRECTIONS FOR USE WERE FOLLOWED, THE STAFF ARE VERY EXPERIENCED AND USED TO PREPARING SMARTLOAD LENSES. THERE ARE NO PLANS TO EXPLANT THE LENS. THERE IS NO MATERIAL AVAILABLE FOR INVESTIGATION AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965993 ↗
• 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 2 OF 3. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE LENSES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909495 ↗
• MalfunctionJul 12, 2023Break; Break

  IT WAS REPORTED THAT DURING THE INSERTION OF THE INTRAOCULAR LENS (IOL), THE DOCTOR COULD SEE A MICROCRACK IN THE OUTER PERIPHERY OF ONE OF THE HAPTICS. THE DOCTOR DECIDED TO KEEP THE IOL IN THE EYE SINCE IT WAS EVALUATED TO NOT HAVE AN IMPACT ON THE PATIENT. THE PATIENT WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312050 ↗
• InjuryMay 26, 2023Break; Break

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE THE SURGEON NOTICED THAT ONE HAPTIC WENT THROUGH THE CAPSULAR BAG AND INTO THE POSTERIOR SEGMENT. THE SURGEON NEEDED HELP FROM A POSTERIOR SURGEON TO CUT THE IOL, REMOVE IT AND REPLACE IT WITH A NEW, 3-PIECE IOL. THE INCISION WAS ENLARGED, A VITRECTOMY PERFORMED AND SUTURES WERE REQUIRED. THIS CAUSED A DELAY AND ANTI- INFLAMMATORY MEDICATION WAS PRESCRIBED. THE SURGEON RAISED THE QUESTION/CONCERN, THAT THIS MIGHT HAVE OCCURRED DUE TO VERY SHARP EDGES AND RIGIDITY OF THE HAPTICS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 17015244 ↗
• MalfunctionOct 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE, THE SURGEON NOTICED THAT THERE WAS A SMALL PLASTIC PIECE IN THE EYE, APPARENTLY FROM THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546945 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A DEFECT. THEREFORE, THE SURGEON CUT IT AFTER IMPLANTATION AND IMPLANTED A NEW IOL. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THERE WAS A ROUND APPROXIMATELY 1MM SIZED FLAW ON THE OPTIC THAT WAS SEEN DURING IMPLANTATION. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE, WHERE THE INCISION WAS ENLARGED, AND THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS. NO OTHER MEDICAL INTERVENTIONS WERE NECESSARY. THE PATIENT'S PRE OPERATIVE VISUAL ACUITY WAS 0.1 AND THE PATIENT'S POST OPERATIVE VISUAL ACUITY WAS 0.1. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14431168 ↗