TECNIS SIMPLICITY DCB00 (REF DCB0000265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474636217), received between Jun 23, 2021 and Aug 11, 2026 — classified as 2 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 18, 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.

• MalfunctionAug 11, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215468 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT'S LEFT EYE. FOLLOWING THE IMPLANTATION, A HOLE WAS IDENTIFIED ON THE PERIPHERY OF THE LENS. DUE TO THE INSTABILITY OF THE ANTERIOR SEGMENT, THE LENS WAS NOT REMOVED AND REMAINS IN THE PATIENT'S EYE. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23380669 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT UNDERWENT PHACOEMULSIFICATION ON (B)(6) 2025, WITH A TECNIS SIMPLICITY MONOFOCAL INTRAOCULAR LENS (IOL) +26.5 D IMPLANTED IN THE LEFT EYE (OS). THIS RESULTED IN A SIGNIFICANT MYOPIC SURPRISE OF -2.50 D THAT REMAINED CONSISTENT. THE SURGEON RECENTLY EXCHANGED THE LEFT LENS FOR THE SAME MODEL, A TECNIS SIMPLICITY MONOFOCAL INTRAOCULAR LENS (IOL) +24.0 D, ON (B)(6) 2025, AND IS CURRENTLY AWAITING THE POST-OPERATIVE FOLLOW-UP. THE PATIENT'S STATUS WAS REPORTED TO BE TEMPORARILY IMPAIRED, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22487004 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION, A HAPTIC BREAKAGE WAS OBSERVED ON THE INTRAOCULAR LENS (IOL). THE TIP OF THE CARTRIDGE AND ONE OF THE HAPTICS WERE IN CONTACT WITH THE PATIENT'S EYE. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE INCIDENT. A BACK UP LENS WAS REQUESTED DUE TO THE ISSUE WITH THE FIRST LENS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391066 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CHROMATIC ABERRATION WAS REPORTED BY THE PHYSICIAN FOLLOWING THE IMPLANTATION OF THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL). PATIENT STATED SHE SEES COLORS DIFFERENT FROM THE ORIGINAL, PRODUCT IS RED SHE SEES GREEN. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, INFORMATION ABOUT THE REPLACEMENT IOL IS UNKNOWN. THERE ARE NO DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT SHE WAS ABLE TO PRIOR TO THE SURGERY. DURING THE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SUTURES, VITRECTOMY, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), AND NO MEDICAL ATTENTION WAS REQUIRED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. BOTH COMPLETELY RECOVERED AND UNKNOWN WERE PROVIDED AS ANSWERS FOR PATIENT STATUS. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20349473 ↗
• MalfunctionAug 13, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS HANDED TO THE SURGEON IN ITS DWELLING LOCATION. THE SURGEON HAD CONFIRMED THE LENS POWER UNDER THE MICROSCOPE AND THEN ADVANCED THE PLUNGER TO BRING THE LENS CLOSE TO THE TIP OF THE INJECTOR TO THE PATIENT'S RIGHT EYE. A SECOND INSTRUMENT IN THE PARACENTESIS WAS USED TO STABILIZE THE GLOBE, PLACED THE INJECTOR INTO THE TEMPORAL WOUND AND ADVANCED THE PLUNGER. AS THE LENS BEGAN TO ENTER THE WOUND A NOTICEABLE CLICK WAS HEARD AND THE SURGEON'S ATTENTION WAS SHIFTED TO THE LENS IN THE INJECTOR ( TYPICALLY OBSERVED THE LENS ENTERING THE ANTERIOR CHAMBER) AND SURGEON BELIEVED HE LIKELY REDUCED THE PRESSURE OF THE INJECTOR INTO THE WOUND. THIS WAS A THICKER LENS AT 26.5D AND THERE WAS SLIGHTLY MORE RESISTANCE THAN A MORE ROUTINE POWER BUT NOTHING UNUSUAL. AT THIS POINT THE PATIENT ROTATED HER EYE NASALLY AND THE LENS REMAINED IN THE WOUND BUT THE INJECTOR WAS NO LONGER SNUG AGAINST THE WOUND. THE LENS STARTED TO UNFOLD THUS BECOMING TRAPPED IN THE WOUND AND OUTSIDE THE INJECTOR CARTRIDGE. FORCEPS WAS USED TO REMOVE THE LENS FROM THE WOUND BUT WHILE HANDLING THE LENS IT FLIPPED OUT OF THE FORCEPS GRIP AND DESPITE EXTENSIVE SEARC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977243 ↗
• MalfunctionMay 19, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT DCB00 INTRAOCULAR LENS MISFIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964996 ↗
• MalfunctionMay 19, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT DCB00 INTRAOCULAR LENS MISFIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963124 ↗
• MalfunctionApr 29, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS "DEFECTIVE". DOCTOR CHANGED ORDER. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841100 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT AS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CRACKED. THE IOL WAS FULLY INSERTED. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION. NO VITRECTOMY OR SUTURE WAS REQUIRED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE LENS CAME CRACKED. IN THIS CASE, THERE WAS NO HANDLING OF THE LENS BY THE DOCTOR. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. "THE RESULT IS FLAT, THERE ARE NO COMPLAINT FROM THE PATIENT. THE CONCERN OF THE DOCTOR IS THE CRACK INCREASING AND IMPACTING THE PATIENT'S VISION OVER TIME OR THE LENS BECOMING OPAQUE." ¿RESULT IS FLAT¿ MEANS THAT THE LENS CORRECTED THE PATIENT'S DEGREE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313547 ↗
• MalfunctionFeb 15, 2022Crack; Crack

  IT WAS REPORTED THAT WHILE INSERTING THE IOL, CARTRIDGE WAS CRACKED. TIP OF THE INJECTOR WAS CRACKED WHEN INSERTING THE LENS. DR. HEARD A POP AND NOTED THE CRACK. VISCOELASTIC WAS NOTED TO BE COMING FROM CRACK BY SCRUB. HOWEVER, IOL WAS IMPLANTED AND INSERTION SYSTEM WAS DISCARDED. POST OP PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION IS AVAILABLE. PER ADDITIONAL INFORMATION RECEIVED, THE DR. DID NOT NOTICE ANYTHING DIFFERENT WHEN TRYING TO IMPLANT. HE JUST REMEMBERS HEARING "THE POP WHEN THE INJECTOR SPLIT.¿ NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536748 ↗
• MalfunctionJun 23, 2021Break; Material Too Rigid or Stiff; Scratched Material; Break; Material Too Rigid or Stiff; Scratched Material

  IT WAS REPORTED THAT THERE WAS RIGIDITY WHEN PUSHING THE PLUNGER FORWARD, THE LENS CAME OUT SCRATCHED AND WITH BENT AND BROKEN HAPTICS. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP WE LEARN THAT THE PLUNGER DID NOT PUSH THE LENS CORRECTLY DUE TO THE RIGIDITY, PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055119 ↗