TECNIS SIMPLICITY DIB00 (REF DIB00U0090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474731530), received between Oct 28, 2021 and Sep 25, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• InjurySep 25, 2026Mechanical Jam

  It was reported that a preloaded monofocal intraocular lens (IOL) would not fire/deploy from the chamber. The cartridge tip touched the patient's right eye. Unplanned sutures were required to protect the eye after attempting to insert the lens. An incision enlargement and unplanned vitrectomy were not required. Another Johnson & Johnson lens (same model and diopter) was implanted as a replacement. Patient status was reported as unknown. The product is not available to return. No other information is available.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900947 ↗
• MalfunctionMar 2, 2026Break; Failure to Advance; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE SUSTAINED DAMAGE DURING A SURGICAL PROCEDURE. ACCORDING TO THE OPERATING ROOM NURSE, THE LENS BECAME STUCK DURING INSERTION, RESULTING IN A BENT HAPTIC. THE INCIDENT DID NOT INVOLVE A PATIENT AND NO ADVERSE EFFECTS OCCURRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE CURRENT PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477547 ↗
• MalfunctionAug 20, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS GOT STUCK. AT THE POINT OF INSERTION THERE WAS A MALFUNCTION WITH THE LOADING CARTRIDGE WHEN ENGAGING WITH THE PRELOADED IOL. THE DEVICE GOT STUCK. THE SURGEON HAD TO USE SUTURES BECAUSE IT CREATED A BIGGER INCISION WHEN THE CARTRIDGE WAS TAKEN OUT. IT IS UNKNOWN IF THERE WAS A CAPSULE TEAR OR OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22856581 ↗
• MalfunctionJun 10, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS TORN OR SCRATCHED DURING IMPLANTATION. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION/APPLICATION. THE LENS WAS IMPLANTED REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS TEMPORARILY IMPAIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180371 ↗
• MalfunctionOct 28, 2021Inaccurate Delivery; Inaccurate Delivery

  CUSTOMER REPORTED THAT THE PRODUCT MISFIRED. THRU FOLLOW-UP THEY EXPLAINED THAT THE PATIENT MOVED. THERE WAS NO DEFECT WITH THE INTRAOCULAR LENS (IOL) AND THIS WAS NOT A DOCTOR ERROR. THE PATIENT MOVED AND CAUSED THE LENS TO MISFIRE. SHE CONFIRMED THERE WAS NO CAPSULE TEAR, VITRECTOMY OR SUTURES. UNKNOWN IF THE IOL GOT DAMAGED BUT THE LENS WAS REMOVED AND REPLACED WITH A BACKUP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712869 ↗