TECNIS SIMPLICITY DCB00 (REF DCB0000115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474635913), received between Feb 26, 2021 and Mar 6, 2026 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS MARKED BY A LINE (SCRATCH). THE LENS WAS NOT IMPLANTED DUE TO THIS ISSUE. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535882 ↗
• MalfunctionMar 6, 2026Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS MARKED BY A LINE (SCRATCH). THE LENS WAS NOT IMPLANTED DUE TO THIS ISSUE. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535876 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE IOL WAS TRACKING ON THE SIDE OF THE TIP. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE BUT NO PATIENT INJURY WAS REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO CONCERNS WERE RAISED REGARDING PATIENT OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877714 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) THE IOL WAS TRACKING ON THE SIDE OF THE TIP. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE BUT NO PATIENT INJURY WAS REPORTED, NOR ANY MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO CONCERNS WERE RAISED REGARDING PATIENT OUTCOMES. NO FURTHER INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876876 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION, THE SURGEON NOTICED THE HAPTIC OF A PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. THIS IOL WAS THEN REMOVED AND REPLACED WITH A BACK UP LENS. THE REMOVAL / REPLACEMENT REQUIRED INCISION ENLARGEMENT AND CAUSED A 20 MINUTE DELAY DURING THE PROCEDURE. NO FURTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22379194 ↗
• MalfunctionJun 30, 2025Wrong Label; Wrong Label

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE TWO INCIDENTS INVOLVING THE INCORRECT SCANNING OF INTRAOCULAR LENS (IOL) IMPLANTS. ON (B)(6) 2025, IT WAS NOTED THAT THE SERIAL NUMBERS FOR THE LENSES WERE CORRECT; HOWEVER, THE SCANNED INFORMATION INDICATED DIFFERENT POWERS THAN WHAT WAS ACTUALLY USED. SPECIFICALLY, A 13.0D LENS WAS SCANNED AS A 21.5D LENS, AND AN 11.5D LENS WAS ALSO INCORRECTLY LOGGED. THIS DISCREPANCY WAS NOT CAUGHT BY THE CIRCULATING PRACTITIONER OR THE SURGEON, LEADING TO POTENTIAL ISSUES WITH PATIENT RECORDS AND FUTURE PROCEDURES. FORTUNATELY, THE CORRECT LENSES WERE IMPLANTED IN BOTH CASES, AND NO PATIENTS WERE HARMED. THE STAFF HAS BEEN ALERTED TO BE MORE VIGILANT DURING THE SCANNING PROCESS TO PREVENT SIMILAR OCCURRENCES IN THE FUTURE. NO FURTHER INFORMATION WAS PROVIDED. A TOTAL OF TWO CASES WERE REPORTED. THE SECOND CASE HAS BEEN CAPTURED IN A SEPARATE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364974 ↗
• MalfunctionFeb 6, 2025Break; Device Difficult to Setup or Prepare; Failure to Advance; Break; Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS DEFECTIVE AND WOULD NOT COME OUT OF THE PRELOADED CARTRIDGES WHEN THE PLUNGER WAS ADVANCED. INSTEAD, THEY STRETCHED THE CARTRIDGE DURING THE ADVANCEMENT, CREATING SIGNIFICANT RESISTANCE. TYPICALLY, THE LENS GLIDES SMOOTHLY OUT OF THE CARTRIDGE WHEN THE SURGICAL TECHNICIAN HAS PREPARED IT AND THE PLUNGER IS TWISTED. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329366 ↗
• MalfunctionFeb 6, 2025Break; Device Difficult to Setup or Prepare; Failure to Advance; Break; Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS DEFECTIVE AND WOULD NOT COME OUT OF THE PRELOADED CARTRIDGE WHEN THE PLUNGER WAS ADVANCED. INSTEAD, THEY STRETCHED THE CARTRIDGE DURING THE ADVANCEMENT, CREATING SIGNIFICANT RESISTANCE. TYPICALLY, THE LENS GLIDES SMOOTHLY OUT OF THE CARTRIDGE WHEN THE SURGICAL TECHNICIAN HAS PREPARED IT AND THE PLUNGER IS TWISTED. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329362 ↗
• MalfunctionDec 13, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN PATIENT'S LEFT EYE AND WAS REMOVED IN THE SAME PROCEDURE DUE TO MALFUNCTION WITH THE INJECTOR. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS DID NOT INJECT PROPERLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926030 ↗
• MalfunctionDec 2, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE. THROUGH FOLLOW UP WE LEARNED THAT DURING PREPARATION OF THE DEVICE, THE SURGEON NOTED THE IOL TO BE CRUMPLED INSIDE THE CARTRIDGE AND DECIDED TO DISCARD. THE PROCEDURE WAS COMPLETED USING A BACK UP IOL. THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827880 ↗
• MalfunctionAug 23, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT RELEASE INTO THE EYE PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053729 ↗
• MalfunctionMar 14, 2024Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR FELT A LOT OF RESISTANCE WHEN HE SCREWED THE DEVICE. THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT COME OUT OF THE TIP OF THE CARTRIDGE PROPERLY. THE IOL WAS MARKED/SCRATCHED ON THE SIDE DURING IMPLANTATION. THE IOL REMAINS IMPLANTED. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907127 ↗
• MalfunctionOct 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AND EXPLANTED DURING THE SAME PROCEDURE AS THE WRONG LENS WAS INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO INJURY, NO SUTURE(S), NO VITRECTOMY, AND A DIFFERENT MODEL IOL WITH THE SAME DIOPTER SIZE, DIB00 11.5 DIOPTER IOL, WAS IMPLANTED. ACCOUNT IS NOT SURE HOW THE SWITCH UP HAPPENED. PATIENT OUTCOME WAS REPORTED AS NO INCIDENT POST-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873349 ↗
• MalfunctionJun 22, 2023Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE LEADING HAPTIC WAS STICKING OF THE INTRAOCULAR LENS ( IOL ) OUT AS THE CAPSULAR BAG WAS AT RISK THE SURGEON REMOVED THE LENS , THROUGH FOLLOW UP WE LEARN THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGERY FROM THE RIGHT EYE . THE PATIENT WAS NOT INJURED , AND WENT FOR A POST OP EXAMEN PRIOR GOING HOME . SURGEON USE COMPETITOR VISCOELASTIC ( OVD ). THE LENS IS NOT AVAILABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187124 ↗
• MalfunctionMar 28, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE AND BENT/BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. THE ISSUE WAS OBSERVED DURING HANDLING. THE LENS WAS NOT INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632995 ↗
• MalfunctionMar 28, 2023Crack; Inaccurate Delivery; Scratched Material; Crack; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS SCREWING THE PRELOADED INTRAOCULAR LENS (IOL), THE LENS WAS NOT MOVING THROUGH THE TIP OF THE CARTRIDGE. LENS WAS PARTIALLY INSERTED AND THE CARTRIDGE TIP SPLIT OPEN. DOCTOR TOOK THE LENS OUT AND RE-INSERTED IT THROUGH AN ALCON CARTRIDGE AND INSERTER. SURGERY WAS COMPLETED WITH NO NEGATIVE IMPACT ON THE PATIENT. HOWEVER, THERE WERE THREE MARKS ON THE SQUARE EDGE OF THE IOL. THE IOL REMAINS IMPLANTED. NO INTERVENTION PERFORMED. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR THE SECOND LENS LISTED ON THE INTAKE FORM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST LENS INVOLVED. THERE WERE TWO LENSES TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632813 ↗
• MalfunctionFeb 26, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS STUCK IN CARTRIDGE, LENS WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT INSERTED. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. THERE WAS NO INCISION ENLARGEMENT AND PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11385530 ↗