TECNIS SIMPLICITY DCB00 (REF DCB0000150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474635982), received between Mar 17, 2021 and May 19, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING INSERTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, A CRACK WAS OBSERVED IN THE LENS. A REPLACEMENT LENS WAS AVAILABLE. ALTHOUGH THE LENS MADE CONTACT WITH THE PATIENT, THE INSERTER WAS REMOVED BEFORE THE LENS ENTERED THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER. THE CARTRIDGE CONTACTED THE PATIENT¿S LEFT EYE; HOWEVER, THE LENS DID NOT. NO PATIENT INJURY WAS REPORTED. THERE WERE NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, INCLUDING VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE CURRENT PATIENT OUTCOME INDICATES NO CONCERNS OR REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212516 ↗
• MalfunctionMar 17, 2026Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH ON THE OPTIC AND WAS NOTICED AFTER BEING INSERTED INTO A PATIENT¿S OPERATIVE EYE. THE LENS REQUIRED REMOVAL, WHICH INVOLVED CUTTING IT INTO SEVERAL PIECES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624265 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081038 ↗
• MalfunctionDec 10, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED LENS WAS FULLY INSERTED AND THEN REMOVED BECAUSE THE INTRAOCULAR LENS (IOL) HAD A SCRATCH ON IT. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER A JOHNSON & JOHNSON IOL OF THE SAME DIOPTER. THERE WERE NO INJURIES OR ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895378 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEFECT. THROUGH FOLLOW-UP, WE LEARNED THAT DURING PREPARATION THE LENS WAS FILLED AND IMPLANTED AS USUAL WITHOUT ANY ISSUES. ONE HAPTIC WAS RESTING DETACHED ON THE IOL. THE LENS WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE. A DELAY IN PROCEDURE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590104 ↗
• InjuryJan 17, 2024Adverse 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 EXPLANTED FROM THE PATIENT'S EYE, DUE TO CHANGE IN POWER WITH PATIENT OUTCOME NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED. .

  Patient problems: Visual Impairment

  MAUDE report 18528286 ↗
• MalfunctionJan 10, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS (IOL) HAD A LOADING ISSUE AND HAD BENT HAPTIC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MODEL AND DIOPTER BACKUP LENS. ADDITIONAL INFORMATION REVEALED THAT THERE WAS NO USE ERROR, WHICH LED TO THE EVENT THAT I AM AWARE OF. THE SURGICAL TECH, UPON PREPARING THE LENS, NOTICED THAT THE TRAILING HAPTIC WAS BENT, SO SHE ASKED FOR A SECOND LENS THAT WAS LOADED WITH NO ERRORS. THE PRODUCT IS NOT AVAILABLE FOR RETUNE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489085 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DCB00 INTRAOCULAR LENS WAS FULLY INSERTED. THERE WAS CAPSULE TEAR, INCISION WAS ENLARGED, VITRECTOMY DONE AND SUTURES WERE PLACED. THE DCB00 LENS WAS REMOVED AND REPLACED WITH OTHER COMPETITOR LENS. PATIENT WAS RECOVERED. THE DCB00 LENS WAS DISCARDED AND NOT BEING RETURNED. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 16950219 ↗
• MalfunctionMar 9, 2023Break; Break

  THE ACCOUNT REPORTED DEFECTIVE INTRAOCULAR LENS (IOL). IT IS UNKNOWN IF THERE WAS PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510689 ↗
• MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN OFF WHEN THE PACKAGE WAS OPENED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048993 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT A PRELOADED SUSPECT PRODUCT WAS REMOVED FROM INVENTORY AS THE INTRAOCULAR LENS (IOL) HAD BENT HAPTIC UPSIDE DOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815043 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO PATIENT UNHAPPY WITH DECREASED VISUAL ACUITY. THE LENS WAS DISCARDED. THE REPLACEMENT LENS IS A DCB00 18.0 SERIAL NUMBER IS (B)(4). THERE WERE NO SUTURES, INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. PATIENT WAS DOING FINE POST-OP. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/100. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/30. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12194083 ↗
• MalfunctionMar 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TORN. THERE WAS NO PATIENT CONTACT, THE LENS WAS NOT INSERTED. THE IOL TORN WAS OBSERVED DURING HANDLING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11500091 ↗