TECNIS SIMPLICITY DCB00 (REF DCB0000285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474636255), received between Nov 12, 2021 and Apr 17, 2026 — classified as 1 injury, 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON OPENING THE OUTER PACKAGING OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE SURGICAL TEAM FOUND THE INNER PACKAGING WAS NOT SEALED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918704 ↗
• MalfunctionSep 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS FULLY INSERTED INTO THE PATIENT LEFT EYE. BUT THE LENS WAS NOT IMPLANTED INTO THE EYE CORRECTLY. SO THE DOCTOR REMOVED THE LENS AND USED THE BACK UP LENS TO COMPLETE THE PROCEDURE. SUTURES WERE NEEDED, AND THERE WAS A DELAY IN THE PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS IT WAS LEARNT THAT THE LENS DID NOT IMPLANT CORRECTLY. IT WAS NOT SURE IF THERE WAS PRODUCT QUALITY ISSUE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302870 ↗
• MalfunctionJul 4, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED, SCRATCHED. THE SCRATCH WAS NOTICED AFTER IT WAS INSERTED IN THE RIGHT EYE. THE SURGEON REMOVED IT AND IMPLANTED A NEW ONE OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. POST-OPERATIVE THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677246 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169420 ↗
• MalfunctionMay 6, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A UNFOLDING ISSUE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW UP, IT WAS CLARIFIED THAT THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL. THE PRODUCT HAS BEEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882817 ↗
• MalfunctionAug 16, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED, THE IOL WAS BENT AND THE SHAFT SPLIT. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236864 ↗
• InjuryApr 4, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) UNFOLDED IN THE RIGHT EYE, IT WAS NOTED THERE WAS A SCRATCH ON THE OPTIC AND NEEDED TO BE REMOVED IN THE SAME PROCEDURE. WHEN THE LENS WAS CUT IN HALF AND REMOVED, ONE OF THE HALVES WAS LOST IN THE DRAPES. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. A VITRECTOMY WAS NOT REQUIRED, HOWEVER, AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14002132 ↗
• MalfunctionNov 12, 2021Material Fragmentation; Failure to Advance; Material Fragmentation; Failure to Advance

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS(IOL) HAD HAPTIC BROKE OFF AND WAS STUCK IN THE INJECTOR. THE EVENT WAS OBSERVED UPON INSERTION. THE LENS MOVED AND THEN GOT STUCK. WHEN PLUNGED OUT THE HAPTIC STAYED IN. THE LEND DID NOT TOUCH THE PATIENT. IT WAS NOTED THAT BALANCED SALT SOLUTION (BSS) WAS USED AND THAT IT WAS AT ROOM TEMPERATURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808036 ↗