TECNIS SIMPLICITY DIB00 (REF DIB00U0280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474731929), received between Sep 9, 2021 and Dec 29, 2025 — classified as 2 injuries, 3 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.

• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE AFTER IMPLANTATION. THE LENS WAS INSERTED AND SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL AND DIOPTER, DURING THE SAME PROCEDURE. NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, SUTURES, OR DELAY IN PROCEDURE OCCURRED. NO PATIENT INJURY WAS REPORTED. THE PATIENT FULLY RECOVERED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907940 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A DEFECTIVE PRELOADED INTRAOCULAR LENS (IOL) WAS IDENTIFIED. THE TIP OF THE LENS WAS FOUND TO BE WARPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285555 ↗
• InjuryJun 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT HAD REPORTED TO THE U.S. FOOD AND DRUG ADMINISTRATION OF AN INTRAOCULAR LENS (IOL) IMPLANT THAT HAD WORSENED SYMPTOMS AND HAD CAUSED NEW PROBLEMS. THE PATIENT STATED THAT THE PROBLEMS CAUSED BY THIS IOL HAVE NOT ABATED SINCE IMPLANT. GLARE IS SIGNIFICANTLY WORSE. ONCOMING HEADLIGHTS NOW APPEAR AS LARGE TRIANGLES WITH RADIATING LIGHT. CONSTANT FLICKERING AT LEFT PERIPHERAL - LIKE HAVE A STROBE LIGHT IN HER EYE. FIELDS OF WHITE, I.E. LAMPS, WHITE PAPER (ESPECIALLY GRIDS) HAVE BLACK DOTS DISPERSED THROUGHOUT, AS WELL AS GLARE. IT WAS NOTED THAT THE SYMPTOMS HAVE REMAINED CONSTANT SINCE IMPLANT. THE PATIENT STATED THAT THE DOCTOR INITIALLY THOUGHT OF PRESCRIBING MEDICINE FOR GLARE. HOWEVER, PRIOR TESTING AT MAYO CLINIC ON THE PATIENT ABILITY TO PROCESS MEDICATION INDICATED A HIGH LIKELIHOOD THAT SHE WOULD EXPERIENCE SIDE EFFECTS AND CONTRAINDICATED THE USE OF MEDICATION FOR THIS ISSUE. NO SURGICAL INTERVENTIONS HAVE BEEN REQUIRED AND THE PATIENT NOTED THAT SINCE SHE LEARNED OF KNOWN PROBLEMS WITH THE LENS MORE THAN SIX MONTHS AFTER SURGERY, SHE WAS TOLD THAT REPLACEMENT OF THE IOL WOULD SIGNIFICANTLY INCREASE THE RISK THAT THE PATIENT WOULD LOSE HER SIGHT IN THIS EYE A

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19640981 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CAPSULAR AND ZONULAR ISSUES RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 15317658 ↗
• MalfunctionSep 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON NOTICED A RESIN MATERIAL ON TOP OF THE PRELOADED INTRAOCULAR LENS (IOL) AFTER IT WAS FULLY IMPLANTED INTO PATIENT'S OPERATIVE EYE. THE SURGEON COULD NOT REMOVE THE MATERIAL AND DECIDED TO KEEP THE LENS IMPLANTED. NO INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448081 ↗