VITAN DK9000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474651494), received between Dec 22, 2021 and Dec 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Contamination; Contamination

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A GCB00 MODEL LENS USING THE VITAN INJECTOR, THE SURGEON OBSERVED A ¿SMALL DOT OF METAL¿ IN THE PATIENT¿S EYE AFTER THE PROCEDURE. THE SURGEON SUCCESSFULLY RETRIEVED THE METAL FRAGMENT FROM THE EYE, THERE WAS A DELAY IN THE PROCEDURE. IT IS UNKNOWN WHETHER THE METAL ORIGINATED FROM THE INSERTER BUT COULD NOT HAVE COME FROM THE GCB00 UNIT. THE PATIENT FULLY RECOVERED, DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901003 ↗
• MalfunctionApr 10, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON NOTICED A METAL SPLINT BEING INJECTED INTO THE EYE, AT THE SAME TIME AS THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED. THE METAL SPLINT WAS REMOVED. NO INFORMATION WAS PROVIDED ABOUT ANY PATIENT COMPLICATIONS. SURGEON STATES THAT HE HAS EXPERIENCED THIS APPROXIMATELY 9 MONTHS AGO, BUT DID NOT TAKE ANY ACTION. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION / APPLICATION. THE IOL WAS FULLY INSERTED AND NO MEDICATIONS WERE REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THERE WAS NO RESISTANCE FELT DURING LENS PREPARATION. IT IS UNKNOWN IF THE FOREIGN MATERIAL CAME FROM THE LENS OR THE INSERTER. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. COMPLAINT (B)(4) WAS OPENED FOR THE ISSUE MENTIONED 9 MONTHS AGO ASSOCIATED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081311 ↗
• MalfunctionOct 18, 2022Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT THE PLUNGER SCRATCHED OVER THE IOL (INTRAOCULAR LENS). THE LENS WAS ALMOST IMPLANTED BUT THE NURSE SAW THAT THE PLUNGER WAS NOT RIGHT, IT WAS ALL OVER THE OPTIC. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621769 ↗
• MalfunctionMar 18, 2022Break; Material Fragmentation; Inaccurate Delivery; Mechanical Jam; Break; Material Fragmentation; Inaccurate Delivery; Mechanical Jam

  IT WAS INITIALLY REPORTED THAT THERE WERE TWO SMART LOAD INTRAOCULAR LENSES THAT COULD NOT BE IMPLANTED AS THEY BOTH WERE STUCK. POSSIBLY THE CARTRIDGE(S) WERE DEFECTIVE, AND ONE LENS HAD A MISSING HAPTIC (HAPTIC WAS NOT THERE). THE TWO DEVICES WERE REPORTED AT THE SAME TIME FOR THE SAME PATIENT. THROUGH FOLLOW UP IT WAS CONFIRMED THE INJECTOR (CUSTOMER IS REFERRING TO THE CARTRIDGE), GOT STUCK AND THE LENSES COULD NOT BE IMPLANTED. BECAUSE OF THE LENSES BEING STUCK, ONE LENS HAD A MISSING HAPTIC AND WAS TAKEN OUT (NOT FULLY DELIVERED, DUE TO BEING STUCK). IT IS UNKNOWN WHICH OF THE TWO IDENTIFIED LENSES HAD THE MISSING HAPTIC ISSUE. THIS REPORT CAPTURES THE EVENT FOR ONE OF THE TWO REPORTED LENSES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER REPORTED LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13809107 ↗
• MalfunctionMar 18, 2022Break; Material Fragmentation; Inaccurate Delivery; Mechanical Jam; Break; Material Fragmentation; Inaccurate Delivery; Mechanical Jam

  IT WAS INITIALLY REPORTED THAT THERE WERE TWO SMARTLOAD INTRAOCULAR LENSES THAT COULD NOT BE IMPLANTED AS THEY BOTH WERE STUCK. POSSIBLY THE CARTRIDGE(S) WERE DEFECTIVE, AND ONE LENS HAD A MISSING HAPTIC (HAPTIC WAS NOT THERE). THE TWO DEVICES WERE REPORTED AT THE SAME TIME FOR THE SAME PATIENT. THROUGH FOLLOW UP IT WAS CONFIRMED THE INJECTOR (CUSTOMER IS REFERRING TO THE CARTRIDGE), GOT STUCK AND THE LENSES COULD NOT BE IMPLANTED. BECAUSE OF THE LENSES BEING STUCK, ONE LENS HAD A MISSING HAPTIC AND WAS TAKEN OUT (NOT FULLY DELIVERED, DUE TO BEING STUCK). IT IS UNKNOWN WHICH OF THE TWO IDENTIFIED LENSES HAD THE MISSING HAPTIC ISSUE. THIS REPORT CAPTURES THE EVENT FOR ONE OF THE TWO REPORTED LENSES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER REPORTED LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13808971 ↗
• MalfunctionDec 22, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE, MODEL GCB00, WAS FRAYED BY THE INJECTOR (VITAN HANDPIECE, MODEL DK9000, LOT 0066). ACCOUNT INDICATED THAT A SICKLE-SHAPED PART IS HANGING FROM THE TIP. THE LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064097 ↗
• MalfunctionDec 22, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE, MODEL GCB00, WAS FRAYED BY THE INJECTOR (VITAN HANDPIECE, MODEL DK9000, LOT 0066). ACCOUNT INDICATED THAT A SICKLE-SHAPED PART IS HANGING FROM THE TIP. THE LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064038 ↗