TECNIS SIMPLICITY DCB00 (REF DCB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 05050474636071), received between Aug 21, 2020 and Sep 1, 2026 — classified as 20 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50553770 ↗
• MalfunctionAug 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50394044 ↗
• MalfunctionJul 27, 2026Break

  It was reported that the preloaded monofocal intraocular lens (IOL) had a torn or broken haptic. Additional information received confirmed that the haptic was bent/broken. It is unknown whether the damage was due to use error or whether any resistance was encountered or excessive force was applied during lens delivery. The cartridge and lens did not come into contact with the patient's left eye, as the event was observed during handling prior to implantation. The procedure was completed using a backup lens of the same model and diopter power. No patient injury was reported, and no vitrectomy, incision enlargement, or suturing was required. It remains unknown whether the device caused or contributed to the event. The patient's outcome was reported as unknown. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50043174 ↗
• MalfunctionJul 27, 2026Crack

  It was reported that the preloaded Johnson and Johnson (JnJ) Intraocular lens (IOL) was implanted into the patient¿s eye. However, the side of the cartridge split during the insertion process. Reportedly, the IOL was implanted successfully with no patient issues. No complications such as vitrectomy, sutures, or incision enlargement. Only the cartridge is available for return.Johnson and Johnson performed follow-up to confirm if the location of the crack was at the tip. The doctor said the cartridges are cracking on the side. It¿s a hairline crack but she can see it. When the doctor starts to inject the lens that¿s when the side of cartridge cracks. The Johnson and Johnson investigation was completed on Jul 10, 2026. The suspect product was received and evaluated. The cartridge tip was observed to be stretched. Because the cartridge was initially reported to have split during patient contact and the investigation confirmed damage to the cartridge tip, this event became reportable based on the investigation results. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50031933 ↗
• MalfunctionJun 10, 2026Break; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED TO HAVE THE FRONT HAPTIC STUCK. NO PATIENT IMPACT WAS REPORTED. FURTHER FOLLOW-UP INDICATED THAT DURING THE PROCEDURE, THE LENS WAS ONLY PARTIALLY DELIVERED INTO THE EYE BECAUSE THE HAPTIC BECAME STUCK ON THE PLUNGER DURING DELIVERY, RATHER THAN PRIOR TO INSERTION. ADDITIONALLY, NO EXTRA SURGICAL MANEUVERS OUTSIDE THE STANDARD OF PRACTICE WERE REQUIRED TO DELIVER OR POSITION THE LENS. NO PATIENT INJURY WAS REPORTED, AND NO UNPLANNED SURGICAL INTERVENTIONS WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO ADDITIONAL PROCEDURES ARE PLANNED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465195 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATARACT OPERATION WAS PERFORMED ON PATIENT. A MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS INITIALLY IMPLANTED. DURING THE PROCEDURE, A POSTERIOR CAPSULE RENT OCCURRED AT THE 6 O'CLOCK POSITION WHILE ROTATING THE IOL, RESULTING IN VITREOUS LOSS. VISCOELASTIC WAS INJECTED, THE MAIN WOUND WAS EXTENDED, AND THE INTRAOCULAR LENS WAS REMOVED DURING THE SAME PROCEDURE. AN ANTERIOR VITRECTOMY WAS THEN PERFORMED. AFTER THIS A THREE-PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25361283 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OPENED AND CORRECTLY FILLED WITH VISCOELASTIC; HOWEVER, AT THE MOMENT OF ENGAGEMENT, IT BROKE. THEREFORE, THE CUSTOMER WAS UNABLE TO PROCEED WITH THE IMPLANTATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24920946 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OPENED AND CORRECTLY FILLED WITH VISCOELASTIC; HOWEVER, AT THE MOMENT OF ENGAGEMENT, IT BROKE. THEREFORE, THE CUSTOMER WAS UNABLE TO PROCEED WITH THE IMPLANTATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24920945 ↗
• MalfunctionApr 16, 2026Crack

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. HOWEVER, THE SIDE OF THE CARTRIDGE SPLIT DURING THE INSERTION PROCESS. REPORTEDLY, THE IOL WAS IMPLANTED SUCCESSFULLY WITH NO PATIENT ISSUES. NO COMPLICATIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. ONLY THE CARTRIDGE IS AVAILABLE FOR RETURN. THE DOCTOR CLARIFIED THAT THE CARTRIDGE CRACKED ON THE SIDE. IT IS A HAIRLINE CRACK, BUT SHE CAN SEE IT. WHEN THE DOCTOR STARTS TO INJECT THE LENS THAT¿S WHEN THE SIDE OF THE CARTRIDGE CRACKS. THE CARTRIDGE WAS RETURNED. HOWEVER, WHEN THE COMPLAINT PRELOADED SIMPLICITY CARTRIDGE WAS RECEIVED IT SHOWED THE CARTRIDGE TIP WAS SLIGHTLY DEFORMED. BECAUSE THE TIP WAS DEFORMED AND IT WAS INITIALLY REPORTED THAT THE DEVICE HAD PATIENT CONTACT THEN THIS CASE HAS BEEN UPDATED TO A REPORTABLE EVENT AND THE AWARE DATE IS THE PI COMPLETION DATE APRIL 01, 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902551 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON OBSERVED A PIECE OF FABRIC IN THE LENS. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP DEVICE. THERE WAS NO REPORT OF PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397649 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND BROKEN. THE LENS WAS NOT IMPLANTED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE LENS WAS DAMAGED AND IN PIECES. THE CARTRIDGE TIP MADE CONTACT WITH THE LEFT EYE, AND IT WAS NOTICED THAT THE LENS HAD SPLIT. THE USER DID NOT APPLY FORCE TO DELIVER THE LENS. A REPLACEMENT LENS, ALSO FROM JOHNSON & JOHNSON WITH THE SAME MODEL AND DIOPTER (DCB00, 19.5 D), WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY OR ANY MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299237 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse; Material Opacification

  IT WAS REPORTED THAT DURING THE UNFOLDING PROCESS OF A SINGLE-PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A CENTRAL INCLUSION DEFECT THAT RESEMBLED A BUBBLE WAS OBSERVED. THE DOCTOR USED MICRO SCISSORS AND FORCEPS TO CUT AND REMOVE THE LENS IN PIECES. SUBSEQUENTLY, A REPLACEMENT IOL WAS IMPLANTED WITHOUT COMPLICATIONS. THE LENS LOADER PREPARATION AND INSERTION PROCESS WENT SMOOTHLY AND WITHOUT ISSUES. THE TECH AND THE DOCTOR STATED THAT THE ISSUES THAT OCCURRED WERE NOT CAUSED BY AN ERROR DURING PREPPING, LOADING, OR INSERTION. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IOL WAS FULLY IMPLANTED IN THE PATIENT'S LEFT EYE WHEN THE MALFUNCTION WAS OBSERVED. THE REPLACEMENT WAS A NON-JOHNSON AND JOHNSON IOL. THERE WERE NO REPORTED PATIENT INJURIES. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. NO MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. THE PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225075 ↗
• 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 23609677 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXPLANTED DURING A PROCEDURE THAT PROGRESSED INTO A VITRECTOMY. A BACKUP LENS WAS USED TO COMPLETE THE SURGERY DURING THE SAME PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22986511 ↗
• MalfunctionAug 28, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON OBSERVED A SCRATCH ON THE PRELOADED INTRAOCULAR LENS (IOL) AND THEREFORE CHOSE NOT TO USE IT ON THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE DID NOT FUNCTION AS INTENDED. ADDITIONAL INFORMATION REVEALED A CENTRAL SCRATCH ON THE OPTIC, NOTICED DURING INSERTION. THE LENS WAS FULLY INSERTED AND THEN REPLACED WITH AN UNKNOWN IOL. THE PATIENT HAS GOOD VISION WITH THE REPLACEMENT IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917232 ↗
• InjuryAug 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT 'S LEFT EYE AS THE EYES WERE NOT WORKING WELL TOGETHER DUE TO A MECHANICAL COMPLICATION. THE REPLACEMENT LENS WAS THE SAME MODEL BUT HIGHER DIOPTER (22.0D). THE INCISION WAS ENLARGED AND SUTURE USED. NO MEDICATIONS OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. NO PATIENT INJURY WAS REPORTED. THE PATIENT OUTCOME IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22877665 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED A HAPTIC OF THE DEVICE WAS FOUND TO BE BROKEN OR MISSING. THERE WAS NO PATIENT INVOLVEMENT, AND NO CONTACT WITH THE PATIENT'S EYE OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734047 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, WE LEARNED THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE DEVICE WAS DISCARDED BY STAFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612549 ↗
• MalfunctionMay 20, 2025Scratched Material; Scratched Material

  RECEIVED A REPORT FROM A PATIENT STATING THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HIS RIGHT EYE. THE PATIENT IS EXPERIENCING BLURRY VISION AND CLAIMS THE IOL MIGHT BE SCRATCHED. THE IOL REMAINS IMPLANTED. REPORTEDLY, THE EVENT OCCURRED ABOUT A WEEK PRIOR TO THEM CALLING JNJ WHICH MEANS THE EVENT OCCURRED AROUND MAY 30, 2025. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP BUT THE TELEPHONE NUMBER PROVIDED BY THE PATIENT WAS NOT WORKING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 22056909 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998964 ↗
• MalfunctionApr 29, 2025Crack; Crack

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED TIGHTNESS WHILE DEPLOYING A PRELOADED INTRAOCULAR LENS (IOL), REQUIRING EXTRA EFFORT. THE CARTRIDGE TIP STRETCHED UNUSUALLY, WHICH WAS NOT TYPICAL. THE SCRUB NURSE NOTED NO RESISTANCE DURING LENS PREPARATION. DESPITE THESE ISSUES, THE SURGEON IMPLANTED THE LENS. THE USED LENS WAS RETAINED FOR POTENTIAL RETURN, AND NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931727 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DURING THE INITIAL PROCEDURE THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY. PATIENT DEVELOPED POST-OPERATIVE ENDOPHTHALMITIS THREE (03) DAYS AFTER UNDERGOING UNCOMPLICATED CATARACT SURGERY. PATIENT'S DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. MEDICAL ATTENTION WAS REPORTED AND MEDICATION WAS PRESCRIBED; INFORMATION REGARDING TYPE OF MEDICAL ATTENTION AND MEDICATION ARE UNKNOWN. PATIENT'S OD VISION PRE-OPERATIVE WAS 20/25 AND POST-OPERATIVE WAS LIGHT PERCEPTION (LP). PATIENT STATUS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Endophthalmitis; Visual Impairment

  MAUDE report 21931236 ↗
• InjuryApr 28, 2025Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS LEAD TO THE HAPTIC UNFOLDED IRREGULARLY, WHICH CAUSED THE HAPTIC TO GRASP THE POSTERIOR CAPSULE AND RESULTED IN A RUPTURED POSTERIOR CAPSULE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21922681 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TOUCHED THE EYE WHEN THE SURGEON NOTICED THAT A CHUNK OF THE LENS WAS MISSING, SO THE SURGEON TOOK THE LENS OUT AND REPLACED IT WITH THE BACK UP IOL. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE IOL WAS CUT OUT AND REPLACED AND THAT THERE WAS NO PATIENT INJURY DURING THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767749 ↗
• MalfunctionMar 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, REMOVED AND REPLACED DURING THE SAME SURGERY AS THE TRAILING HAPTIC WAS DETACHED/MISSING. THE SURGEON HAD TO CUT THE IOL IN ORDER TO REMOVE IT AND REPLACE WITH ANOTHER LENS. THERE WAS A DELAY IN PROCEDURE, HOWEVER, THE LENGTH OF TIME WAS NOT PROVIDED. A VITRECTOMY AND SUTURES WERE NOT REQUIRED, HOWEVER, IT IS UNKNOWN IF THE INCISION WAS ENLARGED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638899 ↗