TECNIS SIMPLICITY DCB00 (REF DCB0000240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05050474636163), received between Jan 15, 2021 and Jun 16, 2026 — classified as 12 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Scratched Material

  IT WAS REPORTED THAT DURING SURGERY INVOLVING THE PRELOADED INTRAOCULAR LENS (IOL), THE INJECTOR SCRATCHED THE OPTIC OF THE LENS. THE DAMAGE WAS NOT IDENTIFIED UNTIL AFTER IMPLANTATION, AND THE SURGEON ELECTED NOT TO EXPLANT THE LENS. NO RESISTANCE OR IRREGULARITY OF THE DEVICE WAS PERCEIVED DURING IOL INJECTION. THE PATIENT WAS INFORMED OF THE SCRATCH ON THE LENS. POST-OPERATIVE VISIT THE DAY AFTER SURGERY REVEALED NO VISUAL DISTURBANCES OR OTHER ABNORMALITIES. NO ADVERSE EFFECTS HAVE BEEN REPORTED TO DATE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524110 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS TWISTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT LENS, AND THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS CONTACTED REGARDING THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25357217 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, WAS IDENTIFIED AS DEFECTIVE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280753 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT PRELOADED MONOFOCAL INTRAOCULAR LENS HAPTIC WAS BROKEN UPON OPENING PRODUCT PACKAGING. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208313 ↗
• MalfunctionApr 23, 2026Break; Crack; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING HANDLING, PRIOR TO INSERTION, THE PRELOADED MONOFOCAL INTRAOCULAR LENS WAS FOUND TO BE FAULTY. THE PLUNGER ADVANCED BENEATH THE LENS, CAUSING THE LENS TO BECOME LODGED IN THE CARTRIDGE. THERE WAS NO PATIENT IMPACT, AS THE SURGEON IDENTIFIED THE ISSUE EARLY AND SUCCESSFULLY IMPLANTED A BACK-UP LENS OF THE SAME MODEL AND DIOPTER TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED, AND THERE WAS NO PATIENT CONTACT WITH THE FAULTY DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975024 ↗
• MalfunctionApr 22, 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 PRODUCT INVESTIGATION (PI) COMPLETION DATE (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948917 ↗
• MalfunctionMar 6, 2026Crack; Mechanical Jam

  CUSTOMER REPORTED THAT THEIR LENS CONTACT WITH THE EYE AND BECAME STUCK INSIDE THE CARTRIDGE. THE CUSTOMER INDICATED THAT THE CARTRIDGE TIP WAS DAMAGED OR CRACKED. IT WAS NOT POSSIBLE TO CONFIRM THIS CONDITION WITH CERTAINTY PRIOR TO USE; HOWEVER, DURING THE SURGICAL PROCEDURE, DIFFICULTIES WERE ENCOUNTERED IN HANDLING THE DEVICE, WHICH REASONABLY SUGGESTS THE PRESENCE OF A DEFECT IN THE CARTRIDGE, A SITUATION THAT COULD NOT BE DETECTED BEFORE ITS USE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528490 ↗
• MalfunctionMar 6, 2026Crack; Mechanical Jam

  CUSTOMER REPORTED THAT THEIR LENS CONTACT WITH THE EYE AND BECAME STUCK INSIDE THE CARTRIDGE. THE CUSTOMER INDICATED THAT THE CARTRIDGE TIP WAS DAMAGED OR CRACKED. IT WAS NOT POSSIBLE TO CONFIRM THIS CONDITION WITH CERTAINTY PRIOR TO USE; HOWEVER, DURING THE SURGICAL PROCEDURE, DIFFICULTIES WERE ENCOUNTERED IN HANDLING THE DEVICE, WHICH REASONABLY SUGGESTS THE PRESENCE OF A DEFECT IN THE CARTRIDGE, A SITUATION THAT COULD NOT BE DETECTED BEFORE ITS USE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528472 ↗
• MalfunctionMar 6, 2026Break; Crack; Device Difficult to Setup or Prepare

  CUSTOMER REPORTED THAT THEIR LENS WAS FORCED INTO THE EYE, RESULTING IN A BROKEN HAPTIC THAT REQUIRED REMOVAL. DURING THE SURGICAL PROCEDURE, DIFFICULTIES IN HANDLING THE DEVICE WERE OBSERVED, WHICH REASONABLY SUGGESTS THE PRESENCE OF SOME DEFECT IN THE CARTRIDGE, A PROBLEM THAT COULD NOT HAVE BEEN DETECTED BEFORE ITS USE. TO ADDRESS THE COMPLICATIONS, ADDITIONAL SURGICAL MANEUVERS AND INSTRUMENTS, INCLUDING A 2.2 MM BLADE, .12 FORCEPS, AND A CURVED MCPHERSON FORCEPS, WERE UTILIZED, AND THE PRIMARY INCISION WAS WIDENED TO ENSURE PATIENT SAFETY. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 24528406 ↗
• MalfunctionFeb 9, 2026Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE SURGEON REALIZED THE PLUNGER OF PRELOADED INTRAOCULAR LENS (IOL) IS SCRATCHING ON THE LENS. THE PLUNGER HAD DAMAGED THE LENS AND THERE WAS RESISTANCE WHILE TURNING THE INJECTOR. IOL DID NOT TOUCH THE PATIENT EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24295920 ↗
• MalfunctionOct 31, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439236 ↗
• MalfunctionMay 23, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080974 ↗
• MalfunctionMay 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING PRODUCT HANDLING AND PRIOR TO INSERTION, THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) WAS SPLIT WHEN THE DOCTOR WENT TO IMPLANT IT. THERE WAS NO PATIENT CONTACT WITH THE IOL, NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION WAS PRESCRIBED, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY. 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 21954027 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REPORTED AS DEFECTIVE. THE IOL WAS NOT IMPLANTED. NO FURTHER DETAILS OR INFORMATION WERE PROVIDED ABOUT THE SPECIFIC NATURE OF THE DEFECT OR THE CIRCUMSTANCES OF THE INCIDENT. THROUGH FOLLOW-UP, WE LEARNED THAT THE CUSTOMER HAS DISCARDED THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947126 ↗
• MalfunctionApr 25, 2025Scratched Material; Physical Resistance/Sticking; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD STICKY HAPTICS THAT LEFT A MARK ON THE INVOLVED IOL. THERE WERE NO DIFFICULTIES DURING THE PROCEDURE, AND ALL ADVISED INSTRUCTIONS WERE FOLLOWED CORRECTLY. WE LEARNED THROUGH FOLLOW-UP THAT THE LENS REMAINS IN THE PATIENT'S EYE, POSITIONED AT 90° WITH THE MARK AT THE TOP. NO EXPLANT WAS NEEDED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911810 ↗
• InjuryApr 24, 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 SINISTER (LEFT EYE). PATIENT UNDERWENT CEIOL + GONIOTOMY ON (B)(6) 2023. MILD POST-OPERATIVE IRITIS WAS REPORTED (B)(6) 2024. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL INTERVENTION REQUIRED TO ADDRESS POST-OPERATIVE IRITIS HOWEVER, PREDNISOLONE ACETATE DROPS WITH SLOWER TAPER WAS PRESCRIBED. THE MEDICATION WAS NOT OUTSIDE OF STANDARD CARE. PATIENT PROGNOSIS AND VISUAL ACUITY WAS REPORTED AS GOOD AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Uveitis

  MAUDE report 21897872 ↗
• MalfunctionApr 4, 2025Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED WHEN THE SURGEON NOTED THE IOL WAS NOT UNFOLDING PROPERLY. HASKIN'S FORCEPS WERE USED TO EXTRACT THE IOL FROM THE INCISION. A BACK UP LENS WAS IMPLANTED WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775136 ↗
• InjuryMar 25, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN OR DEFECTIVE. THROUGH FOLLOW UP, IT WAS LEARNED THE PATIENT WENT IN FOR A ROUTINE CATARACT SURGERY. DURING THE SURGERY, THE SURGEON INSERTED THE LENS INTO THE PATIENT'S OPERATIVE EYE AND THE LENS WAS BROKEN. THE SURGEON REMOVED THE BROKEN LENS AND INFORMED THE PATIENT THEY COULD NOT TREAT THE CATARACT RIGHT AWAY BECAUSE THEY HAD TO LET THE INFLAMMATION IN THE EYE GO DOWN. THE PATIENT WAS THEN SENT TO A SPECIALIST WHO PERFORMED THE CATARACT SURGERY. THE PATIENT ALSO HAD A CATARACT IN THE OTHER EYE AND REPORTED THE OTHER EYE WAS NOT OPERATED ON RIGHT AWAY DUE TO THE ISSUE WITH THE INFLAMED EYE. THE PATIENT CLAIMS BEING INCAPACITATED AS THE PATIENT WAS RECOVERING FROM THE EYE THAT WAS INFLAMED FROM THE BROKEN LENS AND THE OTHER EYE THAT HAD A CATARACT, SO THE PATIENT COULD NOT SEE. ULTIMATELY, THE PATIENT UNDERWENT ADDITIONAL SURGERIES WHICH WERE NOT SPECIFIED. HOWEVER, THE PATIENT HAS BEEN TREATED FOR HER CATARACTS IN BOTH EYES AND IS FULLY RECOVERED. THE PATIENT HAS AS MUCH VISION AS THE PATIENT WAS EXPECTING AND ANTICIPATED TO HAVE FOLLOWING THE CATARACT SURGERIES HAD SHE HAD THE PROCEDURES AS SCHEDULED IN

  Patient problems: Atrophy; Blurred Vision; Corneal Edema; Dry Eye(s); Inflammation; Intraocular Pressure Increased; Pain

  MAUDE report 21692809 ↗
• MalfunctionMar 11, 2025Break; Crack; Ejection Problem; Break; Crack; Ejection Problem

  THE DOCTOR REPORTED ISSUES WITH A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) DURING SURGICAL PROCEDURES, SPECIFICALLY NOTING THAT THE LENS GETS STUCK IN THE MOUTHPIECE OF THE CARTRIDGE, CARTRIDGE TIP AND LENS APPEARED DAMAGE. THE CARTRIDGE/LENS HAD PATIENT CONTACT, WERE INSIDE THE PATIENT'S LEFT EYE TO BE IMPLANTED, BUT THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS. NO MEDICAL/SURGICAL INTERVENTION WAS NECESSARY AND NO SURGICAL INTERVENTION IN FUTURE IS PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569838 ↗
• MalfunctionDec 3, 2024Mechanical Jam; Scratched Material; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PLUNGER OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS DIFFICULT TO ADVANCE AND ONCE ADVANCED THE LENS WAS OBSERVED TO BE SCRATCHED. THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH THE BACK UP LENS OF THE SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE ISSUE WAS NOTICED DURING IMPLANTATION AND APPLICATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20837432 ↗
• MalfunctionNov 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED A SCRATCH ON THE LENS WHILE IMPLANTING IT INTO THE EYE. HE REMOVED THE LENS AND REPLACED IT WITH A BACKUP LENS. THERE WERE NO COMPLICATIONS AND THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798584 ↗
• MalfunctionNov 26, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS LENS SCRATCHED. THE LENS WAS INSERTED INTO THE EYE AND BEFORE THE SURGEON POSITIONED THE LENS, OBSERVED THE SCRATCH ON THE LENS. THE IOL WAS REMOVED FROM THE PATIENT'S OPERATIVE EYE AND CUT WITH A LENS CUTTER. THE LENS WAS REPLACED DURING THE SAME SURGERY WITH ANOTHER LENS OF THE SAME STRENGTH. THERE WAS NO PATIENT HARM AND NO CONCERNS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781798 ↗
• MalfunctionOct 2, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT DEPLOY CORRECTLY. IT LOOKED LIKE IT WAS ROLLED UP. IT WAS LEARNED THAT THE SUSPECT IOL LOOKED LIKE IT WAS THROWN AWAY. IT APPEARED THAT WHEN THE SURGEON WAS DEPLOYING, IT APPEARED THAT THE IOL WASN'T NORMAL. THE IOL NEVER TOUCHED OR HARMED THE PATIENT, AND NO FURTHER TREATMENT OF THE PATIENT WAS NECESSARY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356441 ↗
• MalfunctionSep 27, 2024Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  THE TRAILING HAPTIC OF THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE REMAINED UNFOLDED INITIALLY AND WAS STUCK INSIDE THE CYLINDER, WHICH WAS GENTLY REMOVED AND EXTERNALIZED AND GRABBED WITH A 0 CURVED CALMAN AND GENTLY REMOVED FROM THE SLEEVE KEEPING THE HAPTIC INTACT. THE HAPTIC WAS THEN PLACED UNDERNEATH THE ANTERIOR CAPSULAR FLAP WITH A GOOD CIRCULAR CAPSULORRHEXIS AND THE POSTERIOR CAPSULE INTACT. THE LENS WAS GENTLY NUDGED TO THE CENTER. THE IRRIGATION AND ASPIRATION (I&A) UNIT WAS USED TO REMOVE THE REMAINING VISCOELASTIC. THE WOUND WAS THEN HYDRATED WITH BALANCED SALT SOLUTION (BSS) AND CHECKED FOR LEAKAGE, AND NONE WAS FOUND. ADDITIONAL 0.1 ML OF BRANDED VIGAMOX WAS PLACED IN THE WOUND AND THEN RECHECKED FOR LEAKAGE, AND NONE WAS FOUND. SUBCONJUNCTIVAL INJECTION OF DEXAMETHASONE WAS PLACED 180 DEGREES AWAY FROM THE WOUND AREA. LIGHT CAUTERY WAS USED TO APPROXIMATE THE CONJUNCTIVA OVER THE WOUND AREA. MAXITROL GENERIC OINTMENT WAS PLACED IN THE EYE FOLLOWED BY REMOVAL OF THE LID SPECULUM. TWO (02) LIGHT EYE PATCHES AND FOX SHIELD WERE PLACED IN THE EYE. NUCLEAR SCLEROTIC CATARACT, OCULAR DEXTER (RIGHT EYE) WAS REPORTED AS THE PRE-OPERATIVE DIAGNOSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319154 ↗
• MalfunctionAug 22, 2024Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A FAULTY CARTRIDGE TIP. THE TIP SPLIT IN TWO AND THE IOL COULD NOT BE DEPLOYED. ONLY THE CARTRIDGE TIP HAD CONTACT WITH THE PATIENT'S EYE AND THERE WAS NO INJURY INVOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043553 ↗