TECNIS SIMPLICITY DCB00 (REF DCB0000250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474636187), received between Aug 21, 2020 and Aug 11, 2026 — classified as 10 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212288 ↗
• MalfunctionAug 4, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133590 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN A PATIENT'S RIGHT EYE, A CAPSULAR RUPTURE OCCURRED EITHER DURING LENS UNFOLDING WITHIN THE CAPSULAR BAG OR UPON WITHDRAWAL OF THE INSERTER TIP. THE ACCOUNT SUSPECTED A POSSIBLE SUB-INCISIONAL CAPSULAR PUNCTURE; HOWEVER, THE PHYSICIAN WAS UNCERTAIN OF THE EXACT CAUSE, NOTING IT MAY HAVE BEEN RELATED TO EXCESS OPHTHALMIC VISCOSURGICAL DEVICE (OVD) OR CONTACT WITH THE INSERTER TIP. THE LENS WAS FULLY DELIVERED, AFTER WHICH THE INCISION WAS ENLARGED TO ALLOW EXPLANTATION BY CUTTING AND REMOVING THE LENS. A NON-JOHNSON & JOHNSON 3-PIECE IOL WAS IMPLANTED AS A REPLACEMENT. SUTURES WERE REQUIRED, WHICH WAS NOT PART OF THE PHYSICIAN¿S STANDARD PRACTICE. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 25694243 ↗
• MalfunctionMay 7, 2026Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPANDED PREMATURELY WHILE BEING EJECTED FROM THE CARTRIDGE, WHICH OBSTRUCTED ITS PASSAGE THROUGH THE 2.4MM CORNEAL INCISION. THE REPORT INDICATED THAT THE DEVICE CAME INTO CONTACT WITH THE PATIENT. AS A RESULT, A REPLACEMENT LENS WAS NECESSARY TO COMPLETE THE PROCEDURE. THROUGH FOLLOW UP, IT WAS LEARNED HOW THE DEVICE WAS PREPARED. THE LENS PREPARATION INVOLVED THE USE OF BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE, WHICH WAS FILLED THROUGH THE HYDRATION PORT AND STORED IN THE CARTRIDGE FOR 15 SECONDS TO ONE MINUTE BEFORE BEING HANDED TO THE SURGEON. THE NURSE INITIALLY ADVANCED THE LENS INTO THE CARTRIDGE, AND NO UNUSUAL RESISTANCE WAS NOTED DURING THIS PROCESS. THE CUSTOMER OBSERVED THAT THIS ISSUE IS RARE AND SUGGESTED IT MAY BE RELATED TO THE MANNER IN WHICH THE LEADING HAPTIC TUCKS INTO THE FOLDED OPTIC. NO ADDITIONAL SURGICAL MANEUVERS, UNPLANNED INTERVENTIONS, OR MEDICATIONS WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS VERY GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119695 ↗
• MalfunctionApr 17, 2026Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS MISSING ITS PRIMARY STERILE POUCH UPON OPENING THE BOX (SECONDARY PACKAGING). ONLY THE SYRINGE WAS PRESENT AND THE SECONDARY PACKAGING (BOX) REMAINED CORRECTLY SEALED AND INTACT. THERE WAS NO PATIENT CONTACT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913915 ↗
• MalfunctionMar 10, 2026Break; Scratched Material

  IT WAS REPORTED THAT THE SURGEON OBSERVED A SCRATCH IN THE CENTRAL OPTIC ZONE OF THE INTRAOCULAR LENS AFTER IMPLANTATION INTO THE PATIENT¿S EYE. FOLLOWING EVALUATION, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME DIOPTRIC POWER. THE INCIDENT INCREASED THE DIFFICULTY AND EXTENDED THE DURATION OF THE PROCEDURE. NO ADDITIONAL INTERVENTIONS WERE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565027 ↗
• MalfunctionFeb 19, 2026Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE OUTER PACKAGE OF THE INTRAOCULAR LENS (IOL) WAS FOUND TO BE PROPERLY CLOSED, BUT THE INTERNAL BAG WAS OPEN AT ONE CORNER, APPEARING NOT TO HAVE BEEN SEALED CORRECTLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397546 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POST-OPERATIVELY, THE PATIENT EXPERIENCED REFRACTIVE ERROR AND UNDERWENT A SECONDARY SURGICAL PROCEDURE TO EXPLANT THE LENS. THE REPLACEMENT LENS MODEL AND DIOPTER IS UNKNOWN. PRE-OP REFRACTION WAS PLANO -0.75 @164 WITH A TARGET OF -0.68. THE PATIENT HAD A PRE-EXISTING CONDITION (STATUS POST PHOTOREFRACTIVE KERATECTOMY) AFFECTING CALCULATION. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PROCEDURAL DELAYS OCCURRED. THE PATIENT RECOVERED FULLY WITH NO IMPACT ON DAILY ACTIVITIES; BSCVA REMAINED 20/30 PRE- AND POST-OPERATIVELY. NO POST-OP REFRACTION FOR THE REPLACEMENT LENS YET; HEALING WELL SO FAR. PROCEDURE FOLLOWED DIRECTIONS FOR USE, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23786742 ↗
• MalfunctionNov 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE STIFF, AND THE HAPTICS WERE TAKING LONGER THAN USUAL TO UNFOLD IN THE EYE. THROUGH FOLLOW UP, WE LEARNED THAT ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO POSITION THE IOL IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610261 ↗
• InjuryAug 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT 'S RIGHT EYE DUE TO MECHANICAL COMPLICATIONS OF THE PROSTHETIC. THE REPLACEMENT LENS WAS THE SAME MODEL BUT LOWER DIOPTER (21.5D). THERE WERE NO SURGICAL INTERVENTIONS AND NO MEDICATIONS WERE ADMINISTERED OUTSIDE OF THE STANDARD CARE. NO PATIENT INJURY WAS REPORTED. THE PATIENT OUTCOME IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22877659 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON NOTICED THE IOL TO BE CRACKED IN THE MIDDLE. THE SURGEON THEN CUT THE IOL IN HALF, REMOVED IT AND REPLACED IT WITH A BACK UP IOL. THERE WAS NO REPORT OF PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745814 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THE ISSUE OCCURRED DURING HANDLING PRIOR TO INSERTION, AND IT WAS CONFIRMED THAT THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569125 ↗
• MalfunctionMar 5, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PIECE OF PLASTIC OR METAL WAS FOUND IN THE PATIENT'S EYE DURING IMPLANTATION OF A PRELOADED INTRAOCULAR LENS (IOL). ACCORDING TO THE SURGEON, IT IS NOT RECOGNIZABLE WHICH MATERIAL IS INVOLVED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531812 ↗
• MalfunctionFeb 24, 2025Scratched Material; Appropriate Device Problem Term/Code Not Available; Scratched Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A SCRATCH WAS PRESENT ON MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) AFTER IMPLANTING. DOCTOR WAS UNHAPPY AS HE HAD EXPERIENCED THIS MANY TIMES. THERE WAS NO UNPLANNED INCISION ENLARGEMENT. THERE WERE NO UNPLANNED SUTURES. THERE WAS NO UNPLANNED VITRECTOMY. END USER DIDN'T SEEK MEDICAL ATTENTION. PATIENT IS FULLY RECOVERED. AS PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO PATIENT INJURY, HOWEVER THE IOL HAD TO BE REMOVED AND A NEW IOL WAS IMPLANTED. AS THE SCRATCH WAS IN THE MIDDLE OF THE IOL, LEAVING IT IN WOULD HAVE IMPACTED THE PATIENTS VISION IF IT HAD BEEN LEFT IN, THEREFORE THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND THE BACK UP LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORTS IS BEING SUBMITTED FOR THE DCB00 LENS. ANOTHER REPORT IS BEING SUBMITTED FOR THE SCRATCH ISSUE EXPERIENCED BY SURGEON AN UNKNOWN AMOUNT OF TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447911 ↗
• InjuryFeb 11, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION. THE SURGEON INJECTED THE LENS INTO THE EYE AND FOUND THAT THERE WAS A CRACK IN THE CENTRAL AREA OF THE LENS. THE DAMAGED IOL WAS REMOVED FROM THE EYE AND REPLACED WITH THE IOL OF THE SAME MODEL. THE PATIENT HAD CORNEAL EDEMA AFTER SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 21357447 ↗
• MalfunctionFeb 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTED A SPLIT IN THE IOL. THE IOL WAS REMOVED AND REPLACED WITH AN UNKNOWN JOHNSON & JOHNSON 3 PIECE IOL. HOWEVER, THIS IMPLANTATION WAS ABORTED AS THE SURGEON REPORTED DISSATISFACTION WITH THE EXPERIENCE/ PRODUCT. THE PATIENT REMAINS APHAKIC AND THE SURGEON PLANS TO BRING THE PATIENT BACK TO THE CLINIC WHEN A THIRD, UNKNOWN IOL MODEL WILL BE INSERTED. THROUGH FOLLOW UP WE LEARNED THAT THE ORIGINAL IOL WAS TORN IN THROUGH THE OPTIC SURFACE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST IOL (ORIGINAL) MENTIONED. THE SECOND LENS INVOLVED DOES NOT MEET REPORTABILITY CRITERIA. THEREFORE, NO REPORT WILL BE SUBMITTED AGAINST THE SECOND LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339719 ↗
• MalfunctionSep 12, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK INSIDE THE INJECTOR AND THE HAPTIC OF THE LENS WAS BROKEN. THERE WAS NO IOL CONTACT WITH THE PATIENT'S EYE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208472 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S RIGHT EYE (OD). THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035829 ↗
• InjuryMay 17, 2024Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED INTRAOCULAR LENS (IOL), THE HAPTICS WERE BROKEN AND THE IMPLANT CRACKED. SUBSEQUENTLY, THE LENS HAD TO BE REMOVED AND REPLACED WITH ANOTHER DEVICE. HOWEVER, THIS REPLACEMENT SURGERY WAS COMPLICATED BY INTRAOPERATIVE ISSUES INCLUDING IRIS PROLAPSE, IRIS ATROPHY, AND CORNEAL EDEMA, ALONG WITH A DELAY DURING THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Corneal Edema; Eye Injury; Prolapse

  MAUDE report 19345722 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT WHEN LOADING THE CARTRIDGE WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A CRACK IN THE HAPTICS WAS ALWAYS NOTICEABLE. ACCOUNT INDICATED THAT WHILE MOVING THE PLUNGER FORWARD, THE SURGEON NOTICED THAT THE POSTERIOR HAPTIC HAD AN ABNORMAL KINK. THE ISSUE OCCURRED DURING HANDLING AND THE SURGEON DECIDED NOT TO IMPLANT THE IOL. WHILE PREPARING THE BACK-UP IOL, A DELAY IN PROCEDURE OCCURRED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19253951 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PROCEDURE TURNED INTO VITRECTOMY, SO THE SURGEON ASKED FOR A SECONDARY LENS INSTEAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING PREPARATION FOR USE. IT WAS NOTED THAT THERE WAS NO PATIENT CONTACT, BUT ALSO THAT THE LENS DID NOT ENTER THE CAPSULAR BAG COMPLETELY. THE PROCEDURE WAS COMPLETED WITH A SECONDARY LENS. IT WAS NOTED THAT THE SURGEON DID NOT TAKE THE CARTRIDGE AND LENS ASSEMBLY OUT TOGETHER BEFORE THE LENS COMPLETELY ENTERED THE EYE. THE INCISION WAS NOT ENLARGED. THERE WAS NO PATIENT INJURY. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19127870 ↗
• InjuryJan 29, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WOULDN'T FIT THROUGH THE INCISION AND REQUIRED INCISION ENLARGEMENT AND SUTURE. ONLY THE CARTRIDGE TIP IN CONTACT WITH THE EYE. THE LENS IS BEING RETURNED. THE PATIENT IS FULLY RECOVERED. THERE IS NO INFORMATION ABOUT THE REPLACEMENT IOL. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE

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

  MAUDE report 18603332 ↗
• MalfunctionNov 6, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT OPEN. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT IS BEING FILED FOR THE OTHER IOL THAT WAS REPORTED WITH THE IDENTICAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081001 ↗
• MalfunctionOct 10, 2023Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR INSERTED A MONOFOCAL INTRAOCULAR LENS (IOL) INTO A PATIENT¿S OPERATIVE EYE AND IT WAS THEN DETERMINED THAT IT WAS NOT A GOOD FIT. THE LENS WAS REMOVED, AND THE DOCTOR WENT WITH AN ALTERNATE. IT WAS INDICATED THAT THE LENS IS NOT RETURNING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908374 ↗
• MalfunctionAug 3, 2023Break; Break

  THE SURGERY CENTER REPORTED DAMAGED FROM THE OPERATING ROOM (OR) WITH AN INTRAOCULAR LENS (IOL). IT IS UNKNOWN IF THE PRODUCT HAD PATIENT CONTACT. NO HARM TO THE PATIENT REPORTED. THE DEVICE WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455311 ↗