TECNIS SIMPLICITY DCB00 (REF DCB0000270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474636224), received between Feb 5, 2021 and Mar 19, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE HAPTIC BECAME LODGED WITHIN THE INTRODUCER TRACK. THE SURGERY WAS COMPLETED WITH THE ASSISTANCE OF A SECONDARY INSTRUMENT TO CORRECTLY PLACE THE DEVICE. THE IOL WAS FULLY INSERTED WITHOUT FURTHER ISSUE AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643801 ↗
• MalfunctionSep 10, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK IN A WOUND OF THE PATIENT'S OPERATIVE EYE HALFWAY THROUGH IMPLANTATION. THE LENS HAD TO BE REMOVED USING PLIERS. IT WAS ALSO REPORTED THERE WAS A HANDLING PROBLEM. NO DETAILS WERE GIVEN. DUE TO ITS CONTACT WITH THE PATIENT'S EYE, THE LENS WAS CLASSIFIED AS A BIOHAZARD AND WAS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020520 ↗
• MalfunctionSep 13, 2024Contamination; Contamination

  IT IS REPORTED THAT AFTER IMPLANTING A MONOFOCAL LENS, THE SURGEON NOTICED A "SMALL, THIN Y-SHAPED IRREGULARITY. THE SURGEON INITIALLY THOUGHT IT WAS HAIR, BUT UPON FURTHER EXAMINATION, IT WAS DETERMINED THAT IT WAS SOMETHING ELSE. DESPITE ATTEMPTS TO REMOVE THE PARTICLE, IT COULD NOT BE REMOVED, BUT THE SURGEON DEEMED IT SAFE TO LEAVE IT AS IT WAS SMALL IN SIZE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216493 ↗
• MalfunctionDec 20, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP CRACKED SLIGHTLY DURING LENS INSERTION. IT WAS FURTHER DESCRIBED AS A "STRESS LINE" AT THE TIP OF THE CARTRIDGE. THE SURGEON CONTINUED TO IMPLANT THE LENS AND THERE WAS NO PATIENT INJURY OR PATIENT IMPACT. THE LENS REMAINS IMPLANTED. THE ISSUE OCCURRED SOMETIME BETWEEN (B)(6) 2023, HOWEVER NO SPECIFIC EVENT DATE IS KNOWN. THE SALES REPRESENTATIVE REPORTED THAT IT WAS NOTICED THAT THE CARTRIDGES ARE BEING OVERFILLED WITH BALANCED SALT SOLUTION (BSS) BY THE TECHNICIANS AND TRAINING WAS PROVIDED, HOWEVER THE SALES REPRESENTATIVE WAS UNSURE IF THAT WAS RELATED TO THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369989 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT/BROKEN HAPTIC. TEAR UPON OPENING THE PACKAGE REPORTED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411031 ↗
• MalfunctionMar 24, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC AND TORN IOL. THE ISSUE WAS NOTICED WHILE INSERTING THE LENS INTO THE EYE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611694 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S EYE DUE TO CAPSULE TEAR AFTER BEING FULLY IMPLANTED. IT WAS NOTED THAT PATIENT HAS POSTERIOR SUBCAPSULAR POLAR CATARACTS. IT WAS STATED THAT THERE WAS NO PRODUCT QUALITY ISSUE, PATIENT DOING OKAY POST-OPERATION. ACCOUNT INDICATED THAT THERE WAS SUTURE PERFORMED FOLLOWED BY VITRECTOMY WITH RETINA SPECIALIST. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 15422410 ↗
• MalfunctionMar 21, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED WHEN ADVANCING THE PRE-LOADED INTRAOCULAR LENS (IOL) THE LENS FELT TIGHT. THE DOCTOR LOOKED AT THE LENS BEFORE INSERTING AND THE HAPTIC DID NOT LOOK NORMAL AND DID NOT TRY TO IMPLANT THE LENS. EXTENT OF PATIENT CONTACT IS UNKNOWN. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WERE NO UNPLANNED INCISION ENLARGEMENT, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. THE IOL IS NOT BEING RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13837807 ↗
• MalfunctionAug 20, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A MODEL DCB00 INTRAOCULAR LENS(IOL) HAD EJECTED PRIOR TO INSERTION. ADDITIONAL DETAILS RECEIVED STATES THAT LENS ONLY TOUCHED THE PATIENT'S LEFT EYE, THE LENS WAS EJECTED BEFORE COMPLETELY ENTERING THE EYE. THERE WAS NO INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO USER ERROR. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346563 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT A DCB00 INTRAOCULAR LENS (IOL) WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784141 ↗
• MalfunctionFeb 5, 2021Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE WAS BENT. THE ISSUE WAS OBSERVED DURING IMPLANTATION OF THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290027 ↗
• MalfunctionFeb 5, 2021Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE WAS BENT. THE ISSUE WAS OBSERVED DURING IMPLANTATION OF THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290026 ↗