TECNIS SIMPLICITY DIB00 (REF DIB00U0275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474731912), received between Aug 18, 2022 and Apr 22, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Ejection Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS(IOL) WAS STUCK IN THE INJECTOR ALMOST HAD CUT THE LENS OUT. THE LENS WAS ABLE TO BE REMOVED WITHOUT ANY PATIENT HARM. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884416 ↗
• MalfunctionFeb 7, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT TRAILING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS GETTING STUCK ON THE INJECTOR AND WAS ABLE TO BE RELEASED WITH A FORCEPS TO RIP THE HAPTIC OUT OF THE INJECTOR LEAVING THE HAPTIC OUTSIDE OF THE EYE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT DURING IMPLANTATION OF THE LENS THE TRAILING HAPTIC OF THE LENS HAD STUCK IN THE PRELOADED CARTRIDGE. THE SURGEON HAD TO PULL THE LENS OUT WITH A FORCEPS AND IMPLANT THE LENS. SO THE CARTRIDGE AND THE SHOOTER HAD TOUCHED THE PATIENT'S EYE. THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE AS THERE WAS NOTHING WRONG WITH IT. THE PATIENT IS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335086 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S RIGHT EYE. UPON INSERTION, THE LENS HAD TO BE CUT OUT AND REPLACED. THE DOCTOR NOTICED THAT THE HAPTIC WAS BROKEN ONCE THE PRE-LOADED LENS WAS PLACED IN THE EYE. A BACK UP LENS WAS UTILIZED WITH NO FURTHER COMPLICATIONS. IT WAS NOTED THAT THE BACK-UP LENS USED HAS THE SAME MODEL AND DIOPTER SIZE AS THE SUSPECT IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT POST-OP INJURY. THE SUSPECT IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481665 ↗
• InjuryAug 18, 2022Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PUT THE INTRAOCULAR LENS (IOL)IN THE PATIENT'S LEFT EYE BUT PATIENT'S EYE WOULD NOT HOLD IT. THEY HAD TO CUT THE IOL IN HALF TO TAKE IT OUT AND REPLACED IT WITH A NON JOHNSON AND JOHNSON IOL. IT WAS LEARNED THAT DURING THE PROCEDURE THERE WAS A CAPSULAR WEAKNESS WHICH LEAD TO A POSTERIOR CAPSULAR TEAR. HOWEVER, THE CUSTOMER DID NOT THINK THAT THERE WAS A PRODUCT QUALITY ISSUE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES DONE. THE PATIENT LEFT WITHOUT PROBLEMS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Zonular Dehiscence

  MAUDE report 15255775 ↗