TECNIS SIMPLICITY DCB00 (REF DCB0000255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05050474636194), received between Apr 7, 2021 and Apr 23, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS TWISTED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE THUS, NO INTERVENTIONS WERE REQUIRED. ACCOUNT INDICATED THAT THE IOL WAS OBSERVED TO BE TWISTED, INSIDE THE CARTRIDGE, UPON OPENING THE PACKAGING. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971463 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 A SALES REP WAS PRESENT IN THE OPERATING ROOM AND INDICATED THAT THE SURGEON COULD NOT DETERMINE WHEN THE CAPSULE BAG RUPTURE OCCURRED; WHETHER DURING POLISHING OR DURING IRRIGATION/ASPIRATION. THE ISSUE WAS FIRST RECOGNIZED WHEN THE SURGEON SAW VITREOUS DURING IMPLANTATION OF A DCB00 LENS. THE SURGEON SAW THE LENS DROP TO THE BOTTOM OF THE EYE AND HAD TO FISH THE LENS OUT. A VITRECTOMY AND SUTURE WAS NECESSARY AND THE PATIENT WAS SENT TO ANOTHER SITE TO REPLACE THE INTRAOCULAR LENS (IOL). THE EVENT CAUSED AN APPROXIMATELY 20 MINUTE DELAY IN THE PROCEDURE. THE AFFECTED EYE WAS THE LEFT EYE. THE PATIENT¿S CONDITION AND RECOVERY STATUS ARE CURRENTLY UNKNOWN. SALES REP NOTED THAT THE SURGEON IS RECENTLY GRADUATED AND BELIEVES THE EVENT WAS NOT RELATED TO THE PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NOTE: THIS REPORT IS FOR THE IOL. A SEPARATE REPORT WILL BE FILED AGAINST THE SLEEVE AND I/A HANDPIECE.

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

  MAUDE report 23773017 ↗
• 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 DEXTER (RIGHT EYE). DOCTOR SUSPECTS TOXIC ANTERIOR SEGMENT SYNDROME (TASS) CASE. THE PATIENT UNDERWENT UNCOMPLICATED CEIOL + GONIOTOMY ON (B)(6) 2025. INTRACAMERAL SHUGARCAINE AND MOXIFLOXACIN WERE BOTH GIVEN AS PART OF STANDARD CARE. ON POO3-4, PATIENT DEVELOPED WORSENING EYE REDNESS, TEARING, AND BLURRED VISION. PATIENT'S VISUAL ACUITY (VA) THIS WEEK HAS BEEN ~20/100 WITH SIGNIFICANT DIFFUSE CORNEAL EDEMA AND FLARE OUT OF PROPORTION TO CELLULAR REACTION, WITHOUT VITRITIS. SHE HAD MINIMAL IMPROVEMENT WITH FREQUENT PF THIS WEEK. (B)(6) 2025 PATIENT WAS SENT TO ANOTHER DOCTOR TO RULE OUT (R/O) ENDOPHTHALMITIS. THE SECOND DOCTOR STATED HE THOUGHT THE APPEARANCE WAS MOST CONCERNING FOR TASS. DOCTORS ARE CONTINUING TREATMENT WITH FREQUENT STEROIDS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Corneal Decompensation; Excessive Tear Production; Eye Irritation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21897857 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT AFTER IMPLANTATION, PERIPHERAL SCRATCHES IN THE SHAPE OF TRIANGLES WERE OBSERVED AT THE EDGE OF THE PRELOADED INTRAOCULAR LENS (IOL) OPTIC. ACCORDING TO THE DOCTOR, THE IOL WAS HANDLED IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS. DESPITE THESE STEPS, THE SCRATCHES WERE NOTICED POST-IMPLANTATION. THE PATIENT HAS NOT REPORTED ANY DISCOMFORT OR COMPLICATIONS SO FAR. THROUGH FOLLOW-UP, WE LEARNED THAT THERE ARE NO PLANS FOR LENS EXPLANT OR ANY SURGICAL INTERVENTION AS THE SCRATCHES ARE LOCATED AT THE EDGE OF THE OPTIC AND THEY DO NOT AFFECT THE QUALITY OF VISION. PATIENT HAS A VISUAL ACUITY OF 6/6. NO ISSUES OR COMPLICATIONS HAVE BEEN OBSERVED IN THE POST-OPERATIVE EXAMINATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529340 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT INJECTOR WAS FAULTY. THE TIP WAS A BIT NARROW AS ONLY A SMALL AMOUNT OF VISCOELASTIC WAS COMING OUT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381681 ↗
• MalfunctionNov 4, 2024Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT AFTER OPENING THE SEALED BOX OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGICAL TEAM NOTICED THAT THE INNER BAG PACKAGING WAS NOT SEALED PROPERLY. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE WAS COMPLETED USING A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601246 ↗
• MalfunctionOct 7, 2024Break; Break

  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 20391576 ↗
• MalfunctionApr 5, 2024Contamination; Contamination

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND AROUND THE LEADING HAPTIC WHEN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE. THE FOREIGN MATERIAL WAS REMOVED AT TIME OF PROCEDURES AND SURGERY WAS COMPLETED WITHOUT ANY ADVERSE EVENT TO PATIENT. IOL REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054220 ↗
• MalfunctionAug 23, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON HAD IMPLANTED A PRELOADED INTRAOCULAR LENS (IOL) AND OBSERVED TWO (2) SCRATCHES ON THE LENS. THE SURGEON LEFT THE LENS IN THE EYE AS THE SCRATCHES WERE NOTED OUTSIDE THE OPTIC VISION AREA. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE COMPLAINT. THE IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608402 ↗
• MalfunctionApr 28, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS "DEFECTIVE". THE DEVICE PACKAGING WAS OPENED, BUT THE IOL WAS NOT USED FOR THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839841 ↗
• MalfunctionMar 13, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) EJECTED TOO EARLY. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535057 ↗
• MalfunctionFeb 23, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION, THE OPHTHALMOLOGIST NOTICED THAT THE LENS HAD A LARGE CENTRAL LINE ON THE ANTERIOR SURFACE. SHE DECIDED TO REMOVE IT, SO SHE ENLARGED THE INCISION, PARTIALLY CUT THE LENS AND REMOVED IT. ANOTHER IOL WAS THEN IMPLANTED. THE PATIENT HAD NO INJURY; HOWEVER, THE DURATION OF THE OPERATION WAS EXTENDED BY 10 MINUTES. THROUGH FOLLOW WE CONFIRMED THAT THE LARGE CENTRAL LINE WAS A SCRATCH ON THE CENTRAL PART OF THE OPTIC. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433350 ↗
• MalfunctionNov 14, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, THE HAPTICS WERE STUCK TO THE OPTIC. THERE WAS MANIPULATION WHERE A PADDLE WAS USED ON THE OPTIC SURFACE OF THE IOL TO MOVE THE HAPTICS. THIS RISKED SCRATCHING THE SURFACE OF THE LENS. THERE WAS A DELAY IN TREATMENT OF TWO MINUTES. THERE WERE NO INTERVENTIONS PERFORMED. NO PATIENT INJURY WAS REPORTED. THE PATIENT HAS FULLY RECOVERED. THE IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789059 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED AND WAS OBSERVED DURING PROCEDURE IN THE PATIENT'S RIGHT EYE. SURGEON'S OPINION IS THAT THE PATIENT'S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM OR ANY SURGICAL INTERVENTION REQUIRED. A MONARCH CARTRIDGE WAS USED WITH DUOVISC VISCOELASTIC SYSTEM. IT IS UNCLEAR IF THE MONARCH CARTRIDGE USED WITH PRELOADED DEVICE OR IF IT WAS USED WITH REPLACEMENT LENS. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 14416482 ↗
• MalfunctionMay 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE, HOWEVER; IT WAS REMOVED FROM THE EYE AS IT WAS MISSING A HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14293542 ↗
• MalfunctionApr 1, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT HAS BEEN REPORTED THAT PRODUCT WAS DEFECTIVE. THROUGH FOLLOW-UP IT WAS LEARNT THAT AT THE MOMENT TO INJECT AND FIT, THE HAPTICS CAME OUT BENT AND IT WAS DECIDED TO DISCARD IT AND IMPLANT A SIMILAR LENS; THE TIP AND THE LENS WERE IN CONTACT WITH THE PATIENT'S EYE; ONLY SECONDS OF DELAY AND PATIENT IS UNDER FAVORABLE EVOLUTION AND HAPPY WITH VISION GOTTEN. CUSTOMER IS NOT ABLE TO CONFIRM IF WHETHER THIS MATERIAL IS AVAILABLE OR NOT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979739 ↗
• MalfunctionFeb 14, 2022Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE. ACCOUNT PROVIDED THAT THE LENS WAS LOADED AS USUAL; HOWEVER, IT WAS SCRATCHED. SURGERY WAS COMPLETED USING A BACK-UP LENS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE LENS IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13527063 ↗
• MalfunctionFeb 11, 2022Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED DEVICE WAS DEFECTIVE. PHOTO OF THE DEVICE WAS PROVIDED, THE IMAGE APPEARS TO SHOW TIP OF CARTRIDGE WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518946 ↗
• MalfunctionSep 30, 2021Break; Failure to Advance; Break; Failure to Advance

  THE CUSTOMER REPORTED A KINKED HAPTIC AND THE SURGEON WAS NOT HAPPY WITH THE LOADING OF THE TECNIS SIMPLICITY PRELOADED INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558540 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL DCB00, WAS DAMAGED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533896 ↗
• MalfunctionAug 12, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) TORE OFF IN THE EYE, DURING IMPLANTATION. THE LENS WAS REMOVED AND A NEW IOL WAS IMPLANTED WITH GOOD SURGERY RESULTS. THERE WAS NO PATIENT INJURY AND NO SURGICAL COMPLICATIONS REPORTED. THE IOL WAS DISCARDED IN THE FIELD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316544 ↗
• MalfunctionApr 12, 2021Scratched Material; Scratched Material

  IT WAS REPORTED BY THE SURGEON THAT A DCB00 INTRAOCULAR LENS (IOL) HAD A SCRATCH ON THE TOP CORNER OF THE OPTIC. THE LENS IS STILL IMPLANTED AND THE PATIENT IS DOING FINE. NO FURTHER ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649019 ↗
• InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TECNIS SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DUE TO MECHANICAL ISSUES. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATION. THE CUSTOMER INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11626157 ↗