TECNIS SIMPLICITY DCB00 (REF DCB0000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 05050474636101), received between Feb 5, 2021 and Sep 18, 2026 — classified as 14 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Scratched Material

  It was reported that, during handling and prior to insertion, the preloaded monofocal intraocular lens (IOL) was scratched during the loading process. There was no patient contact with the device. The IOL was discarded. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821161 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765422 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243879 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024248 ↗
• MalfunctionJun 26, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT DURING INTRAOCULAR LENS (IOL) PREPARATION, IT WAS OBSERVED A RUPTURE (TEAR) WHILE THE LENS WAS STILL IN THE CARTRIDGE/INJECTOR. UPON IDENTIFICATION OF THE DEFECT, THE LENS WAS IMMEDIATELY DISCARDED AND ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETED THE PROCEDURE. THROUGH FOLLOW-UP WE LEARNED THAT THE ISSUE WAS OBSERVED PRIOR PATIENT CONTACT. PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639941 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY AND NOT USED ON A PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523776 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT DURING INSERTION OF A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC SNAPPED OFF. THE IOL WAS REMOVED AND A REPLACED WITH AN IOL OF THE SAME MODEL AND DIOPTER. THE IOL WAS IMPLANTED SUCCESSFULLY WITHOUT ANY FURTHER INTERVENTION. IT WAS BELIEVED THAT THIS WAS A DEFECTIVE LENS AND THE HAPTIC WAS ALREADY DAMAGED PRIOR TO INSERTION. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913517 ↗
• MalfunctionFeb 13, 2026Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH ON IT, IT WAS OPENED AND NOT USED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338865 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819118 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN THE RIGHT (OD) AND LEFT EYE (OS), THE PATIENT DEVELOPED POSTERIOR CAPSULE OPACIFICATION (PCO) IN BOTH EYES. THE ISSUE FOR BOTH EYES WAS FIRST NOTED DURING A SUBJECT VISIT. THE PCO WAS RESOLVED WITH A YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY PROCEDURE ON (B)(6) 2025 OS, AND ON (B)(6) 2025 OD. THERE WERE NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REPORTED. THE PATIENT'S PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS RECORDED AS 30 OS AND 20 OD, AND POST-OPERATIVE BSCVA IMPROVED TO 20 FOR BOTH EYES. NO LIMITATIONS IN ACTIVITIES OF DAILY LIVING WERE REPORTED BY THE PATIENT. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED IN BOTH EYES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE OD. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE EVENT FOR THE OS.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23796928 ↗
• MalfunctionNov 26, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT UPON INSERTION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED A BLEMISH ON THE LENS AND THE SURGEON SUBSEQUENTLY REMOVED IT FROM PATIENT'S OPERATIVE EYE BY CUTTING IT IN HALF. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). IT WAS UNKNOWN IF THERE WAS PATIENT INJURY, COMPLICATIONS, OR SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663226 ↗
• 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 23608871 ↗
• 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 23608365 ↗
• MalfunctionNov 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT LENS HAPTIC WAS STUCK TOGETHER WHEN IMPLANTED INTO THE EYE. THERE WAS DELAY IN PROCEDURE AND SURGEON HAD TO USE A SECOND INSTRUMENT TO SEPARATE THE HAPTICS. PATIENT WAS NOTED TO HAVE POOR VISION POST OP. NO SIGNIFICANT IMPACT TO DAILY ACTIVITIES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23589827 ↗
• MalfunctionNov 7, 2025Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTICS STUCK TOGETHER INSIDE THE EYE. THE SURGEON EMPLOYED A SECOND INSTRUMENT TO SEPARATE THE HAPTICS, WHICH CAUSED A DELAY OF APPROXIMATELY ONE MINUTE. THE PATIENT¿S STATUS WAS UNKNOWN, AND DAILY ACTIVITIES WERE NOT AFFECTED. THE INCISION WAS NOT ENLARGED, A VITRECTOMY WAS NOT PERFORMED, AND NO MEDICATIONS WERE ADMINISTERED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND IT IS UNCLEAR WHETHER SUTURES WERE REQUIRED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500869 ↗
• InjuryOct 30, 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),MODEL DCB00 WAS IMPLANTED IN THE PATIENT'S LEFT EYE. DURING POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED EXPERIENCING A CONSTANT DARK ARCH IN THE TEMPORAL FIELD OF VISION. THE INTRAOCULAR LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON JOHNSON AND JOHNSON PRODUCT OF 20.5 DIOPTER. THE PROCEDURE REQUIRED INCISION ENLARGEMENT AND SUTURES, HOWEVER, NO VITRECTOMY REPORTED. NO DELAY IN THE PROCEDURE WAS INDICATED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE THE STANDARD OF CARE WAS MENTIONED. THE PATIENT HAS FULLY RECOVERED. THE DIRECTION FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23430165 ↗
• MalfunctionOct 6, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A DEFECT WAS OBSERVED ON THE EDGE OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AFTER IT HAD BEEN IMPLANTED IN THE PATIENT'S EYE. THE IOL WAS REMOVED, AND A NEW LENS WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE WELL CARED FOR, WITH NO FURTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23228176 ↗
• InjurySep 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A PROCEDURE INVOLVING TECNIS LENS A PRELOADED MONOFOCAL IOL WITH +21.0D SPECIFICATION WAS IMPLANTED BUT WAS FOUND TO BE SPLIT. THE LENS WAS REMOVED FROM THE EYE AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND +21.0D SPECIFICATION. THE PATIENT¿S OUTCOME WAS GOOD, WITH NO ISSUES. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059539 ↗
• MalfunctionAug 20, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THERE WAS AN ISSUE DURING THE PRIMING OF AN INTRAOCULAR LENS WHEREBY A CLICKING SOUND WAS NOTED, AND IT APPEARED THAT THE PLUNGER HAD PENETRATED THE LENS. THERE WAS NO PATIENT INVOLVEMENT AND LENS WAS NOT INSERTED INTO THE PATIENT'S EYE. A BACKUP LENS WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857029 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT WHEN LENS PACKAGED WAS OPENED, IT WAS FOUND THAT THE INTRAOCULAR LENS (IOL) OPTIC WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922389 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IDENTIFIED AS DEFECTIVE. ADDITIONAL INFORMATION INDICATING THAT THE HAPTIC WAS BROKEN AND DAMAGED DURING MANUFACTURING. THE ISSUE WAS DISCOVERED WHEN THE LENS WAS REMOVED FROM THE BOX ON THE BACK TABLE. A NEW J&J LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT WITH IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915071 ↗
• MalfunctionApr 17, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK INSIDE THE CARTRIDGE AND IT WAS BENT. A REPLACEMENT LENS WAS IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE TIP WAS IN CONTACT WITH THE PATIENT'S EYE. THE PATIENT IS WELL WITH A 20/20 VISION. THE REPLACEMENT LENS HAS THE SAME DIOPTER. THE TYPE OF LUBRICATION USED WAS 2% METHYLCELLULOSE FROM A DIFFERENT MANUFACTURER AND IT WAS INTRODUCED IN THE HOLE OF THE CAP. BALANCED SALT SOLUTION WAS NOT USED. THE DWELL TIME WAS LESS THAN 1 MINUTE. AS SOON AS THE 2% METHYLCELLULOSE WAS INTRODUCED, THE INITIAL MOVEMENT (FIRST CLICK) WAS MADE BY THE AUXILIARY DOCTOR. THE SURGEON ALREADY INTRODUCED THE IOL IN THE EYE WHEN THE LENS GOT STUCK WITHOUT PROGRESSION. COMPLETE TURNS WERE PERFORMED WHEN ADVANCING THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857411 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT PRELOADED MONOFOCAL LENS WAS DEFECTIVE AND WASTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529083 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO REPORTED PATIENT INJURY, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE NECESSARY. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THE PATIENT'S POSTOPERATIVE OUTCOME WENT WELL, WITH A FOLLOW-UP SCHEDULED FOR THE NEXT DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 21428639 ↗
• MalfunctionFeb 13, 2025Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND WAS NOT IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE TIP OF THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT'S EYE. DUE TO THE DEFECT IN THE CARTRIDGE ITSELF, IT WAS NOT POSSIBLE TO INSERT THE LENS. IT WAS NOT NECESSARY TO DO ANYTHING EXCEPT REPLACE THE IOL. THE DEFECT WAS IDENTIFIED AS BEING IN THE TIP OF THE CARTRIDGE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377783 ↗