TECNIS IOL DIU225 (REF DIU225U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474747135), received between Sep 17, 2021 and Nov 27, 2024 — classified as 6 malfunctions.

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

• MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN DURING INSERTION. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791424 ↗
• MalfunctionApr 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED UPON INSERTION, THE HAPTIC OF THE DIU225 INTRAOCULAR LENS (IOL) WAS SHEARED OFF AND LEFT IN THE INSERTER; THERE WAS PATIENT CONTACT. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO USE ERROR, AND NO VITRECTOMY. THE DIU225 REMAINS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718171 ↗
• MalfunctionAug 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE. AFTER INSERTION, THE SURGEON NOTICED THE LENS WAS TORN. THE IOL WAS REMOVED FROM THE EYE AND A REPLACEMENT IOL WAS IMPLANTED. NO COMPLICATIONS WERE REPORTED. THE REMOVED LENS WAS DISCARDED AT THE SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214974 ↗
• MalfunctionFeb 28, 2022Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A FOREIGN BODY ON TOP OF THE EYHANCE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. THE FOREIGN BODY WAS SAFELY REMOVED AND THE LENS REMAINS IMPLANTED. THE PATIENT OUTCOME WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625508 ↗
• MalfunctionDec 30, 2021Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY WAS PREPARED AS USUAL WITH SALINE; HOWEVER, WHEN ADVANCING THE IOL THE TECHNICIAN NOTICED RESISTANCE. THE SURGEON IMPLANTED THE LENS AND NOTICED A CRACK IN THE OPTIC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP IOL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122629 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT THE LENS CAME OUT SIDEWAYS. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE CARTRIDGE WAS SPLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490647 ↗