TECNIS SIMPLICITY DCB00 (REF DCB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 05050474636125), received between Apr 6, 2021 and Sep 23, 2026 — classified as 20 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Scratched Material; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874888 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201831 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient developed endophthalmitis in the left eye following implantation of a monofocal one-piece intraocular lens (IOL). Additional information indicated that a culture was performed and yielded a positive result, with Enterococcus faecalis (4+ growth) identified. The infection was reported to be recurrent in nature, resulting in explantation of the IOL on (b)(6) 2026. Prior to explantation, the symptoms reportedly significantly interfered with the patient's daily activities. The lens was not replaced. The patient was reported to be aphakic and experiencing corneal edema and intraocular inflammation, with silicone oil fill present and vision reported as counting fingers. The current treatment plan is to await clearance of the infection.During the cataract procedure, topical treatment was reported. No subconjunctival, systemic, or intraocular treatment was reported, and no unplanned vitrectomy was required. No over-the-counter medications were reported. Information regarding prescribed medications was not provided. The reporter indicated that no pattern had been observed among similar cases and stated that the cause of the endophthalmitis was uncertain. No Jo

  Patient problems: Endophthalmitis

  MAUDE report 50181834 ↗
• MalfunctionJul 27, 2026Scratched Material

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046754 ↗
• MalfunctionJun 25, 2026Difficult to Fold, Unfold or Collapse

  THE CUSTOMER REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL), A HAPTIC BECAME ADHERED TO THE OPTICAL ZONE OF THE LENS AFTER IMPLANTATION INTO THE CAPSULAR BAG. THE SURGICAL TEAM SEPARATED THE HAPTIC AFTER MULTIPLE ATTEMPTS USING AN INTRAOCULAR LENS POSITIONING HOOK, AFTER WHICH THE HAPTIC GRADUALLY UNFOLDED AND MOVED INTO THE CORRECT POSITION WITHIN THE CAPSULAR BAG. THE ADHESION OF THE HAPTIC TO THE OPTICAL ZONE INCREASED THE COMPLEXITY OF THE SURGERY AND RESULTED IN A PROLONGED PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630591 ↗
• MalfunctionJun 19, 2026Operating System Becomes Nonfunctional; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) PLUNGER CUT THE LENS IN HALF WHEN ADVANCING IN THE PATIENTS EYE. THERE WAS NO PATIENT CONTACT. THE PRODUCT HAS BEEN DISCARDED AND NOT AVAILABLE FOR PRODUCT EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565609 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED REGARDING A JOHNSON & JOHNSON (J&J) INTRAOCULAR LENS (IOL). THE PATIENT¿S COUSIN REPORTED THAT THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF J&J INTRAOCULAR LENSES AND SUBSEQUENTLY DEVELOPED SIGNIFICANT VISION ISSUES APPROXIMATELY THREE WEEKS POSTOPERATIVELY. THIS REPORT PERTAINS TO THE RIGHT EYE. THE PATIENT REPORTED EXPERIENCING BLURRED VISION IN LIGHTED CONDITIONS, INABILITY TO SEE AT NIGHT, AND INCREASING DIFFICULTY PERFORMING DAILY FARMING ACTIVITIES, INCLUDING OPERATING MACHINERY AND DRIVING, WHICH HAS IMPACTED THE PATIENT¿S INDEPENDENCE AND SAFETY. THE PATIENT RESIDES IN A FARMING COMMUNITY. THE PATIENT¿S PHYSICIAN REPORTEDLY ADVISED WAITING SIX MONTHS TO UNDERGO A LASER PROCEDURE DUE TO THE DEVELOPMENT OF A FILM OVER THE PATIENT¿S EYES. THE REPORTER EXPRESSED DISSATISFACTION WITH LOCAL OPHTHALMIC CARE PRACTICES, STATING THAT OPTOMETRISTS, RATHER THAN OPHTHALMOLOGISTS, ARE DIRECTING PATIENT CARE. THE REPORTER FURTHER INDICATED THAT PATIENTS MAY NOT ALWAYS CONSULT DIRECTLY WITH SURGEONS PRIOR TO PROCEDURES. ADDITIONALLY, THE REPORTER EXPRESSED CONCERN THAT OTHER INDIVIDUALS IN THE LOCAL FARMING COMMUNITY MAY HAVE EXPERIENCED SIMILAR VISION I

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 25446752 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO A MYOPIC SURPRISE. ANOTHER JOHNSON & JOHNSON LENS, MODEL DCB00 18.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE CUSTOMER STATED THAT NO FURTHER INFORMATION REGARDING THE COMPLAINT IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 25211868 ↗
• MalfunctionApr 29, 2026Contamination

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOTED TO HAVE RED SPECS AFTER IMPLANTATION. THE LENS WAS DELIVERED AND IMPLANTED AS IT WAS INITIALLY DEEMED ACCEPTABLE, DESPITE THE PRESENCE OF SPECS OBSERVED IN THE DELIVERY SYSTEM. NO DETAILS WERE PROVIDED REGARDING THE PATIENT¿S CONDITION, VISUAL ACUITY OUTCOMES, OR WHETHER ADDITIONAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035331 ↗
• MalfunctionApr 23, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974600 ↗
• MalfunctionApr 11, 2026Crack; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PLUNGER OF A SINGLE-PIECE, PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CAME THROUGH THE SIDE OF THE TIP AND WAS UNABLE TO ADVANCE THE LENS. THE EVENT WAS OBSERVED DURING HANDLING, PRIOR TO INSERTION BUT DURING FOLLOW UP THE ACCOUNT STATED THE CARTRIDGE TOUCHED THE PATIENT'S EYE. THERE WAS PATIENT CONTACT BUT NO HARM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A JOHNSON AND JOHNSON IOL WITH THE SAME MODEL AND DIOPTER AS A BACKUP REPLACEMENT. THERE WERE NO UNPLANNED MEDICAL OR SURGICAL INTERVENTION, AND THE DEVICE WAS NOT REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THIS WAS FOR THE PATIENT'S RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847777 ↗
• MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; Wrong Label

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) EXPERIENCED AN UNEXPECTED POSTOPERATIVE MYOPIC SHIFT OF APPROXIMATELY -1.25 DIOPTERS IN THE LEFT EYE, WHICH DIFFERED FROM THE INTENDED REFRACTIVE OUTCOME. THE IMPLANTED LENS WAS EXPECTED TO PRODUCE RESULTS CONSISTENT WITH THE PATIENT¿S RIGHT EYE BECAUSE PREOPERATIVE AND POSTOPERATIVE BIOMETRY MEASUREMENTS FOR BOTH EYES WERE NEARLY IDENTICAL. THE TREATING PHYSICIAN SUGGESTED THAT THE DISCREPANCY MIGHT BE DUE TO THE LENS LABELED AS 22.00 DIOPTER (D) WHEN IT COULD POTENTIALLY BE CLOSER TO 23.00D. NO ADDITIONAL ADVERSE EVENTS OR HARM TO THE PATIENT WERE INDICATED. THE PHYSICIAN REPEATED THE BIOMETRY, CONFIRMING THE ACCURACY OF THE MEASUREMENTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24328784 ↗
• MalfunctionJan 8, 2026Material Opacification

  IT WAS REPORTED THAT A PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED TO HAVE A BLACK SPOT ON THE LENS INSIDE THE INSERTER PRIOR TO IMPLANTING THE INTRAOCULAR LENS. THE OCCURRENCE TOOK PLACE DURING HANDLING, BEFORE INSERTION, WITH NO CONTACT MADE WITH THE PATIENT. THE IOL WAS NOT USED AND INSTEAD A BACKUP LENS WAS UTILIZED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007481 ↗
• MalfunctionDec 12, 2025Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, SURGEON OBSERVED A SCRATCH ON THE IOL. IOL REMAINS IN THE EYE. THE CARTRIDGE TIP WAS FOUND TO BE DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795697 ↗
• 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 23609536 ↗
• 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 23601037 ↗
• 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 23601021 ↗
• 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 23600474 ↗
• MalfunctionNov 7, 2025Break; Material Too Rigid or Stiff; Break; Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING PRIMING OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON FELT RESISTANCE FROM THE PLUNGER. AFTER THE IOL WAS IMPLANTED, THE SURGEON FOUND A CRACK ON THE IOL. THROUGH FOLLOW UP, WE LEARNED THAT THE IOL REMAINS IMPLANTED AND THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498770 ↗
• InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) DISLOCATED DURING SURGERY AND WAS REMOVED IN PIECES. ANOTHER LENS WAS IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

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

  MAUDE report 23432945 ↗
• MalfunctionOct 27, 2025Use of Device Problem; Use of Device Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS DISCARDED DUE TO USER ERROR AS PER THE DOCTOR. WHEN ASKED WHEN THE ISSUE FIRST IDENTIFIED, BOTH "DURING HANDLING/PRIOR TO INSERTION" AND "LENS INSERTED AND REMOVED DURING SAME PROCEDURE" INFORMATION WERE PROVIDED AS ANSWERS. IT IS UNKNOWN IF THE SAME PROCEDURE WAS COMPLETED USING A BACK-UP LENS; HOWEVER, THERE WAS NO INCISION ENLARGEMENT, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397695 ↗
• MalfunctionOct 15, 2025Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FAILED WHILE ENGAGING THE LENS AND SCRATCHED THE LENS. THERE WAS NO PATIENT CONTACT. A DIFFERENT LENS WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287200 ↗
• MalfunctionOct 15, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A CATARACT SURGERY, A PRELOADED SINGLE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED TO BE DAMAGED DURING HANDLING PRIOR TO ANY CONTACT WITH THE PATIENT. IT IS UNKNOWN HOW THE LENS WAS DAMAGED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286330 ↗
• MalfunctionAug 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN LENS WAS INSERTED INTO THE PATIENT'S EYE, THE HAPTICS STUCK TO THE INTRAOCULAR LENS (IOL) OPTIC AND WOULD NOT UNFOLD. DUOVISC VISCOELASTIC WAS USED. THE SURGEON TRIED TO RELEASE HAPTICS WITH BSS AND PROVISC AND MANIPULATED WITH DRYSDALE. THE HAPTICS EVENTUALLY UNFOLDED. SURGERY WAS DELAYED FOR 5 MINUTES. THERE WAS NO INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867973 ↗
• MalfunctionAug 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN LENS WAS INSERTED INTO THE PATIENT'S EYE, THE HAPTICS STUCK TO THE INTRAOCULAR LENS (IOL) OPTIC AND WOULD NOT UNFOLD. DUOVISC VISCOELASTIC WAS USED. THE SURGEON TRIED TO RELEASE HAPTICS USING IRRIGATION AND ASPIRATION, DRYSDALE, AND PROVISC BUT WITHOUT SUCCESS. THE HAPTICS EVENTUALLY UNFOLDED AFTER TEN MINUTES. SURGERY WAS DELAYED FOR AT LEAST TEN MINUTES. THERE WAS NO INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867893 ↗