TECNIS SIMPLICITY DIB00 (REF DIB00U0070)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474731493), received between May 26, 2022 and Aug 31, 2026 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Failure to Advance; Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532542 ↗
• MalfunctionMar 2, 2026Mechanical Jam; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) GOT STUCK AT THE TIP OF THE CARTRIDGE. THE LENS WAS PARTIALLY INSERTED. IT WAS ALSO REPORTED THE LENS WAS INSERTED IN THE PATIENT'S RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE. THE PATIENT FULLY RECOVERED. THE DIRECTIONS FOR USE WERE FOLLOWED, AND THERE WAS A DELAY IN THE PROCEDURE, BUT NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED OUTSIDE OF STANDARD CARE. THERE WERE NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492198 ↗
• MalfunctionDec 28, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) PLUNGER STARTED TO OVERRIDE THE LENS. THERE IS NO EVIDENCE OF DAMAGE ON THIS CARTRIDGE. THE NURSE WAS ABLE TO SUCCESSFULLY RETRIEVE THE LENS, LOAD IT MANUALLY IN A SEPARATE CARTRIDGE, AND USED A PLATINUM INSERTER. THE LENS WAS DEFECTIVE TO SOME DEGREE. THERE WAS PATIENT CONTACT AS THE CARTRIDGE TIP CONTACTED THE EYE. AN INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS NOT REQUIRED. THERE WAS NO NEED FOR ANY FURTHER PATIENT INTERVENTION. THE PATIENT WAS DISCHARGED HOME WITHOUT ANY ISSUE AND HAS FULLY RECOVERED. THROUGH FOLLOW UP IT WAS CONFIRMED THERE WAS NO DAMAGE TO THE CARTRIDGE AT ALL. IT WAS REPORTED THE CARTRIDGE WAS LUBRICATED WITH A COMPETITOR BALANCE SALT SOLUTION (BSS) WITH ADDED ADDITIVES. 0.5 MILLIMETER (ML) OF EPINEPHRINE WAS ADDED TO THE BSS BAG (500 ML). THIS SOLUTION IS USED TO PRIME THE CARTRIDGE WITH. THE LENS IS NOT AVAILABLE AS IT WAS LOST IN THE COMMOTION DURING THE SURGERY, HOWEVER, THE INSERTER WITH CARTRIDGE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION TO PROVIDED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415857 ↗
• MalfunctionDec 28, 2023Break; Mechanical Problem; Mechanical Jam; Break; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) PLUNGER STARTED TO OVERRIDE THE LENS AND WOULD NO LONGER PUSH THE LENS FORWARD. THE PLUNGER THEN EXITED THE END OF THE CARTRIDGE WITH THE LENS STILL PARTIALLY STUCK INSIDE THE CARTRIDGE. THE SIDE OF THE CARTRIDGE HAS BEEN DAMAGED BY THE PLUNGER. AND THE LENS WAS DEFECTIVE TO SOME DEGREE. THERE WAS PATIENT CONTACT AS THE CARTRIDGE TIP CONTACTED THE EYE. AN INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS NOT REQUIRED. THERE WAS NO NEED FOR ANY FURTHER PATIENT INTERVENTION. THE PATIENT WAS DISCHARGED HOME WITHOUT ANY ISSUE AND HAS FULLY RECOVERED. THROUGH FOLLOW UP IT WAS LEARNED THAT THE TIP OF THE CARTRIDGE WAS NOT DAMAGED. THERE WAS HOWEVER A LONG OUTWARD PROTRUSION ALONGSIDE THE CARTRIDGE AS IF THE PLUNGER HAD SCRAPED THE CARTRIDGE AS IT WAS BEING MOVED. IT WAS REPORTED THE CARTRIDGE WAS LUBRICATED WITH A COMPETITOR BALANCE SALT SOLUTION (BSS) WITH ADDED ADDITIVES. 0.5 MILLIMETER (ML) OF EPINEPHRINE WAS ADDED TO THE BSS BAG (500 ML). THIS SOLUTION IS USED TO PRIME THE CARTRIDGE WITH. THE LENS IS NOT AVAILABLE AS IT WAS LOST IN THE COMMOTION DURING THE SURGERY, HOWEVER, THE INSERTER WITH CARTRIDGE IS AVAILABLE FOR RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415338 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, WAS REMOVED DUE TO CAPSULE TEAR. THE INCISION WAS ENLARGED AND A 3 PIECE LENS WAS USED AS THE REPLACEMENT. A VITRECTOMY WAS NOT REQUIRED. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14505646 ↗