TECNIS SIMPLICITY DCB00 (REF DCB0000185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 05050474636057), received between Nov 13, 2020 and Feb 6, 2026 — classified as 10 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  A TORN CAPSULAR BAG WAS NOTED AFTER THE IMPLANTATION OF A DCB00 MODEL INTRAOCULAR LENS (IOL). THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH AN AR40E 18.0 IOL, THAT WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THERE WAS NO INCISION ENLARGEMENT AND NO SERIOUS PATIENT INJURY DURING THE PROCEDURE. SUTURES WERE APPLIED, THOUGH NOT AS A PROPHYLACTIC MEASURE, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS EXCELLENT. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24285121 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE FOR AN UNKNOWN REASON. IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED ANY HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24250903 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S OPERATIVE EYE AFTER IT ROTATED AND DID NOT SIT IN THE BAG. THE REMOVE IOL WAS REPLACED WITH A THREE-PIECE LENS. NO VITRECTOMY WAS PERFORMED ON THE PATIENT. THE ORIGINAL LENS WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835368 ↗
• MalfunctionNov 19, 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 23600641 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT SURGEON IMPLANTED A PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. REPORTEDLY THE LENS HAD A FAULT IN THE MIDDLE WHEREBY THERE WAS A DEFORMITY. THE LENS HAD TO BE CUT AND REMOVED, WHICH DID NOT RESULT IN ANY INJURY TO THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999877 ↗
• MalfunctionAug 19, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS JAMMED. THE CUSTOMER STATED THAT THE LENS WAS IMPLANTED AND EXPLANTED IN SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845706 ↗
• MalfunctionJul 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS MISSING A HAPTIC WHICH WAS NOTICED BY THE DOCTOR AFTER THE IOL WAS INSERTED INTO THE PATIENT¿S EYE. HE ROTATED THE LENS AND DECIDED NOT TO REMOVE IT TO SEE HOW THE PATIENT WILL RESPOND. DURING A POST-OPERATIVE VISIT ON (B)(6) 2025, THE SURGEON SCHEDULED AN EXPLANTATION PROCEDURE. THE IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH THE SAME MODEL AND DIOPTER. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SYMPTOMS. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414714 ↗
• MalfunctionApr 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED WITH MISSING HAPTIC. THE DOCTOR NOTICED THE MISSING HAPTIC AFTER IMPLANTATION AND DECIDED TO LEAVE THE IOL IMPLANTED WITHOUT ANY ISSUES. IT REMAINS IMPLANTED. NO INJURY OR INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931732 ↗
• MalfunctionApr 22, 2025Crack; Crack

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS COMING OUT OF THE SIDE OR TIP OF THE DEVICE AND DEVICE DID NOT WORK AS INTENDED. THE IOL MAY HAVE BEEN EXITING FROM THE TOP OR SIDE, POSSIBLY DUE TO A MICRO-CRACK. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885837 ↗
• InjuryMar 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF WRONG POWER, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS, B&L IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21658514 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IRIS FIXATED LENS, MODEL AR40, WAS IMPLANTED INSTEAD OF THE ORIGINAL PRELOADED INTRAOCULAR LENS (IOL) AS THERE WAS A CAPSULE TEAR. THE MATERIAL WAS DISCARDED AND NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21569169 ↗
• MalfunctionJan 10, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE BROKE DURING HANDLING WHEN THE SURGEON PUSHED THE PRELOADED MONOFOCAL INTRAOCULAR LENS FOR THE HYDRATION. THE LENS ALSO BROKE IN THE CARTRIDGE. THERE WAS NO CONTACT BETWEEN SIMPLICITY AND THE PATIENT. DIRECTIONS OF USE WERE FOLLOWED AND PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129835 ↗
• InjuryDec 26, 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 PATIENT'S RIGHT EYE AS THE PATIENT EXPERIENCED DYSPHOTOPSIA AND A GASH FOLLOWING AN EYE PROCEDURE. THE PATIENT WAS REPORTED TO HAVE BEEN PERMANENTLY IMPAIRED, WITH SOME DAILY ACTIVITIES AFFECTED. THE LENS WAS REMOVED AND REPLACED WITH NON JNJ LENS IN A SECONDARY PROCEDURE. THE PATIENT HAD FULLY RECOVERED. THE BEST SPECTACLE CORRECTED VISUAL ACUITY PRE-OP WAS: 20/30 AND THE BEST SPECTACLE CORRECTED VISUAL ACUITY POST-OP WAS: 20/15.NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21023634 ↗
• MalfunctionOct 1, 2024Crack; Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED/DEFECTIVE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS PROVIDED REPORTING A CRACKED INJECTOR TIP. THROUGH FOLLOW UP, IT WAS CLARIFIED THAT THE DEFECTIVE DEVICE WAS DUE TO THE CARTRIDGE TIP DAMAGE. THERE WAS NO LENS DAMAGE. THE CUSTOMER WAS ABLE TO FULLY INSERT AND IMPLANT THE LENS. A BACK-UP LENS WAS NOT REQUIRED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS UNKNOWN. THE LENS REMAINS IMPLANTED. THE DELIVERY SYSTEM WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348997 ↗
• MalfunctionSep 6, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164161 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED AND A HAPTIC WAS MISSING. THE IOL HAD TO BE REMOVED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS FULLY INSERTED AS A REPLACEMENT AND REMOVED DURING THE SAME PROCEDURE, AS THE HAPTIC WAS MISSING AS WELL. IT WAS ALSO REPORTED THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY. THE PATIENT STATUS WAS UNKNOWN. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT, SUTURES, OR A VITRECTOMY WERE REQUIRED. THROUGH FOLLOW UP, IT WAS LEARNED THERE WAS NO SECONDARY SURGERY ON AN ANOTHER DATE PERFORMED. THE LENS IMPLANTED ON THE THIRD TRY WAS ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). THERE WAS NO ISSUES. IT IS UNKNOWN WHICH SERIAL NUMBER WAS THE ORIGINAL LENS OR THE REPLACEMENT LENS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE INTRAOCULAR LENS MODEL DCB00 SERIAL NUMBER (SN) 3846422344. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE DCB00 SN 3867372344.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029238 ↗
• MalfunctionAug 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED AND A HAPTIC WAS MISSING. THE IOL HAD TO BE REMOVED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS FULLY INSERTED AS A REPLACEMENT AND REMOVED DURING THE SAME PROCEDURE, AS THE HAPTIC WAS MISSING AS WELL. IT WAS ALSO REPORTED THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY. THE PATIENT STATUS WAS UNKNOWN. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT, SUTURES, OR A VITRECTOMY WERE REQUIRED. THROUGH FOLLOW UP, IT WAS LEARNED THERE WAS NO SECONDARY SURGERY ON AN ANOTHER DATE PERFORMED. THE LENS IMPLANTED ON THE THIRD TRY WAS ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). THERE WAS NO ISSUES. IT IS UNKNOWN WHICH SERIAL NUMBER WAS THE ORIGINAL LENS OR THE REPLACEMENT LENS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE INTRAOCULAR LENS MODEL DCB00 SERIAL NUMBER (SN) (B)(6). A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE DCB00 SN.(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013688 ↗
• MalfunctionAug 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) TORE WHILE ENGAGING AND THE CARTRIDGE TIP HAD CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969264 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE LENS, IT WAS NOTICED THERE WAS A CRACK IN THE OPTICAL CENTER OF THE LENS. THE LENS HAD TO BE CUT INTO 2 PIECES, THE INCISION ENLARGED AND THE 2 PIECES REMOVED. NEW LENS WAS PLACED WITHOUT ISSUE. THE PATIENT WAS DOING FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19924067 ↗
• MalfunctionJul 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE WITH NO PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW UP IT WAS LEARNED THAT THE TRAILING HAPTIC WAS MISSING, NO PATIENT CONTACT WAS REAFFIRMED. NO PATIENT INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823664 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED WHEN TAKING THE DCB00 MODEL LENS OUT OF THE PACKAGE, THE INTRAOCULAR LENS (IOL) WAS DAMAGED. THERE WAS NO PATIENT CONTACT WITH THE IOL. BACK-UP IOL WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581376 ↗
• InjuryJun 19, 2024Break; Break

  IT WAS REPORTED DURING IMPLANTATION THE DCB00 MODEL INTRAOCULAR LENS (IOL), THE BACK HAPTIC BROKE AND THERE WAS PATIENT CONTACT WITH THE CARTRIDGE TIP. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND MEDICAL ATTENTION WAS NOT REQUIRED. IT IS UNKNOWN IF SUTURES WERE REQUIRED AND UNKNOWN IF MEDICATION WAS PRESCRIBED. IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS TEMPORARILY IMPAIRED HOWEVER PATIENT'S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19567279 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAS HAPTIC DISFIGURED DURING IMPLANTATION, WHILE BEING PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE. BUT SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER LENS. THE PATIENT FULLY RECOVERED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, UNKNOWN IF SUTURES PERFORMED OR IF THERE WAS DELAY IN PROCEDURE. DIRECTIONS FOR USE WAS FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367665 ↗
• MalfunctionMay 21, 2024Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY DUE TO THE HAPTIC "SNAPPING" AND THE IOL FAILING TO DEPLOY. THROUGH FOLLOW UP IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367300 ↗
• MalfunctionApr 2, 2024Break; Mechanical Jam; Break; Mechanical Jam

  PER COMPLETED COMPLAINT FORM REPORT WAS ON DEFECTIVE LENS/CARTRIDGE RELEASE PER MD, DURING HANDLING. IT ALSO NOTED LENS STUCK IN CARTRIDGE AND LENS SCRATCHED. NO PATIENT CONTACT HOWEVER FORM NOTED THAT RIGHT SIDE OF EYE AFFECTED. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF PATIENT'S DAILY LIFE. NO OTHER INFORMATION WAS PROVIDED OR CLARIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021409 ↗