TECNIS SIMPLICITY DCB00 (REF DCB0000155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474635999), received between Aug 9, 2021 and Sep 30, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the preloaded monofocal intraocular lens (IOL) was explanted due to unknown reason. Additional information received indicated that the lens was discarded by operating room staff. No additional information was provided.

  Patient problems: Eye Injury

  MAUDE report 50949039 ↗
• MalfunctionJun 24, 2026Physical Resistance/Sticking

  DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC OF A SINGLE-PIECE PRELOADED MONOFOCAL IOL WAS OBSERVED TO ADHERE TO THE OPTIC AFTER DELIVERY INTO THE CAPSULAR BAG. MULTIPLE ATTEMPTS USING AN IOL POSITIONING HOOK WERE REQUIRED TO SEPARATE THE ADHERED HAPTIC. FOLLOWING SEPARATION, THE HAPTIC GRADUALLY UNFOLDED AND WAS SUCCESSFULLY POSITIONED WITHIN THE CAPSULAR BAG. THE ADHESION OF THE HAPTIC INCREASED PROCEDURAL DIFFICULTY AND RESULTED IN PROLONGED SURGICAL TIME. NO PRODUCT REPLACEMENT WAS REQUIRED DURING THE PROCEDURE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614552 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED FROM THE PATIENT'S LEFT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25491563 ↗
• 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 23609620 ↗
• MalfunctionJun 21, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303498 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE, THE PATIENT EXPERIENCED DYSPHOTOPSIA, GLARE, GHOSTING, STARBURST, HALOS, AND REDUCED CONTRAST SENSITIVITY. SYMPTOMS PERSISTED FOR FOUR MONTHS. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT FULLY RECOVERED. DIRECTIONS FOR USE WAS FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 21026865 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY INSERTED PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY SURGERY DUE TO DYSPHOTOPSIA, GLARE, GHOSTING, STARBURST, HALOS, AND REDUCED CONTRAST SENSITIVITY. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. DIRECTIONS FOR USE WERE FOLLOWED. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (LI61AO +16.0). NO UNPLANNED SUTURES, VITRECTOMY, OR INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 20887781 ↗
• MalfunctionJul 24, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS JAMMED BETWEEN THE PLUNGER AND THE INJECTOR WALL WHILE ATTEMPTING TO INJECT. THE PLUNGER DAMAGED THE HAPTIC. SO THE LENS WAS NOT IMPLANTED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE ISSUE WAS NOTICED DURING HANDLING/PRIOR TO INSERTION. USE ERROR IS UNKNOWN, AS TECHNICIAN DID NOT SEE THE ISSUE UNTIL AFTER THE DOCTOR SAID SOMETHING ABOUT IT THERE WAS NO ABNORMAL CONDITION NOTICED. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS WITH THE SAME MODEL AND DIOPTER. THERE WAS NO PATENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. REPORTEDLY THE SCRUB NURSE LIKELY DID NOT USE ENOUGH BSS (BALANCED SALT SOLUTION) WHILE PRIMING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822639 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) THAT IS NEEDED TO BE UN-OPENED BUT WHEN OPENED THE LENS IT WAS ALREADY DAMAGED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068760 ↗
• MalfunctionJun 1, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR HAD A SCRATCHED DCB00 INTRAOCULAR LENS. ADDITIONAL INFORMATION REVEALED THAT THE SCRATCH WAS NOTICED AFTER HYDRATION, PRIOR TO INSERTION AND THE LENS DID NOT MAKE ANY CONTACT WITH PATIENT. THERE WAS NO USE ERROR AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING UNKNOWN BACKUP LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040296 ↗
• MalfunctionApr 21, 2023Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PREPPED PER MANUFACTURER INSTRUCTIONS FOR USE (MIFU) AND HANDED TO THE SURGEON FOR INSERTION INTO THE RIGHT EYE. THE SURGEON IMPLANTED THE LENS BUT OBSERVED THAT THE INSERTER SPLIT THE OPTIC OF THE LENS IN HALF DURING INSERTION. HALF OF THE LENS WAS TRAPPED IN THE INSERTER AND THE OTHER HALF WAS REMOVED FROM THE PATIENTS EYE. A BACKUP LENS WAS PULLED AND THE SURGERY CONTINUED WITHOUT ISSUE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY. THERE WERE NO ADVERSE EVENTS NOTED AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. IT WAS NOTED THAT IT WAS HIGHLY UNLIKELY THAT THE ISSUE WAS DUE TO USE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792484 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE AND THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER) IN THE SAME PROCEDURE DUE TO A CRACK IN THE LENS/DEFECTIVE LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163514 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT THE LENS WAS DAMAGED. THE EVENT WAS NOTICED PRIOR TO PATIENT CONTACT. IN THE SURGEON¿S OPINION THE PRODUCT CAUSED OR CONTRIBUTE TO THE EVENT. REPORTEDLY, THE EVENT OCCURRED DURING PRELOADING. LIKELY MEANT DURING PREPARATION. AS THIS A PRELOADED DEVICE, FOLLOW-UP WAS DONE TO GET CLARIFICATION ON THE REPORTED ISSUE, BUT THE CUSTOMER DID NOT RESPOND WITH CLARIFICATION. REPORTEDLY, THERE WAS NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A NON-PRELOADED JNJ LENS, IOL MODEL ZCB00 15.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978531 ↗
• MalfunctionOct 31, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A MISSING/DETACHED HAPTIC. THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S LEFT EYE. THE ISSUE WAS OBSERVED WHILE INSERTING INTO THE EYE. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND DIOPTER). THE PATIENT OUTCOME IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700846 ↗
• MalfunctionFeb 18, 2022Break; Failure to Fold; Inaccurate Delivery; Break; Failure to Fold; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED LENS WAS DAMAGED WHEN THE CUSTOMER TRIED TO USE IT. IT WAS STATED THAT THE LEAD HAPTIC DEPLOYED AT AN ANGLE THAT THE SURGEON WAS UNABLE TO INSERT IT INTO THE CAPSULE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564543 ↗
• MalfunctionAug 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A BLACK FIBER ON IT. IT WAS OBSERVED AFTER THE IMPLANTATION OF THE LENS INTO THE PATIENT'S OPERATIVE EYE. THE SURGEON IRRIGATED THE FIBER OUT AND PROCEEDED TO USE THE LENS. IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298493 ↗