TECNIS SIMPLICITY DCB00 (REF DCB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 05050474636118), received between Nov 13, 2020 and Sep 24, 2026 — classified as 15 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892420 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50031937 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). THE PATIENT¿S COUSIN, WHO IS AN OB-GYN DOCTOR, REPORTED TO JOHNSON AND JOHNSON THAT THE PATIENT HAD JOHNSON AND JOHNSON INTRAOCULAR LENSES IMPLANTED IN BOTH EYES AND EXPERIENCED SIGNIFICANT VISION ISSUES THREE WEEKS AFTER THE IMPLANTATION. THIS REPORT CAPTURES THE LEFT EYE. THE PATIENT REPORTED BLURRY VISION IN THE LIGHT, THE INABILITY TO SEE AT NIGHT, AND INCREASING DIFFICULTY WITH DAILY FARMING ACTIVITIES. INCLUDING OPERATING MACHINERY AND DRIVING WHICH AFFECTS HIS INDEPENDENCE AND SAFETY. THE PATIENT RESIDES IN A FARMING COMMUNITY. REPORTEDLY, THE PATIENT¿S PHYSICIAN ADVISED WAITING SIX MONTHS FOR A LASER PROCEDURE DUE TO A FILM DEVELOPING OVER HIS EYES. THE PATIENT¿S COUSIN EXPRESSED DISSATISFACTION WITH OPHTHALMIC CARE PRACTICES IN THEIR STATE, SPECIFICALLY NOTING THAT OPTOMETRISTS, RATHER THAN OPHTHALMOLOGISTS, ARE DIRECTING PATIENT CARE. HE REPORTED THAT PATIENTS' MAY NOT BE DIRECTLY CONSULTING WITH SURGEONS PRIOR TO PROCEDURES. HE IS CONCERNED ABOUT THE PROCESS, SUGGESTING THAT OTHER FARMERS IN THE AREA HAVE EXPERIENCED SIMILAR VISION PROBLEMS AND QUESTIONED WHETHER THERE MAY BE AN IS

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 25446779 ↗
• InjuryMay 15, 2026Ejection Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE IMPLANTATION OF A MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL), THE LENS IMPINGED ON CAPSULE, CAUSING AN ANTERIOR CHAMBER RUPTURE AND REQUIRING AN ANTERIOR VITRECTOMY. THE LENS WAS NOT IMPLANTED. THE INCIDENT TOOK PLACE DURING THE IMPLANTATION OR APPLICATION PROCESS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25191847 ↗
• MalfunctionApr 19, 2026Break

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS FAULTY AS IT WAS OBSERVED TO BE TWISTED WITHIN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921188 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING INTRAOCULAR LENS (IOL) WITH MODEL DCBOO AND DURING IRRIGATION AND ASPIRATION(VISCOELASTIC REMOVAL), THE OPTIC WAS NOT CENTERED TO THE CAPSULE BAG AND VITREOUS PROLAPSE OCCURRED. ANTERIOR VITRECTOMY PERFORMED. NO FURTHER INFORMATION AVAILABLE. THIS REPORT CAPTURES INFORMATION FOR IOL. ANOTHER REPORT WILL CAPTURE INFORMATION FOR PHACO SYSTEM.

  Patient problems: Vitreous Loss

  MAUDE report 24722658 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), IT HAD A FAULTY HAPTIC, BUT THE SURGEON MANAGED TO IMPLANT THE LENS. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT IS DOING FINE POST-OPERATIVELY. SINCE THE LENS WAS IMPLANTED, ONLY THE DELIVERY SYSTEM IS AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656451 ↗
• MalfunctionMar 2, 2026Crack

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE BY THE SURGEON DURING A PRE-INSERTION CHECK. ACCOUNT INDICATED THAT THE TIP OF THE CARTRIDGE WAS DAMAGED. THE DEVICE WAS IN CONTACT WITH THE PATIENT BUT HE IOL WAS NOT INSERTED. NO PATIENT INJURY RESULTED FROM THIS MALFUNCTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491603 ↗
• MalfunctionMar 2, 2026Crack

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE BY THE SURGEON DURING A PRE-INSERTION CHECK. ACCOUNT INDICATED THAT THE TIP OF THE CARTRIDGE WAS DAMAGED. THE DEVICE WAS IN CONTACT WITH THE PATIENT BUT HE IOL WAS NOT INSERTED. NO PATIENT INJURY RESULTED FROM THIS MALFUNCTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491527 ↗
• MalfunctionFeb 26, 2026Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) UPON OPENING THE PACKAGE, THE SEAL WAS FOUND TO BE COMPROMISED, POTENTIALLY DUE TO GLUE FAILURE, WHICH RAISED CONCERNS ABOUT STERILITY. THE SURGEON REPORTED THAT THE SEAL WAS NOT PROPERLY ADHERED. THE LENS WAS NOT USED, DID NOT COME INTO CONTACT WITH ANY PATIENT, AND NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. THE CUSTOMER CONFIRMED THAT THE LENS OF THE AFFECTED INTRAOCULAR LENS WAS NOT IMPLANTED OR EXPOSED TO THE PATIENT. THE DEFECTIVE LENS IS UNAVAILABLE FOR INVESTIGATION, AND THE CUSTOMER REPORTED THAT THE OUTER SHIPPING BOX WAS UNDAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465167 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A CATARACT SURGERY AND SUBSEQUENTLY DEVELOPED ENDOPHTHALMITIS. THERE WAS UNPLANNED VITRECTOMY PERFORMED. THE LENS WAS EXPLANTED AND PATIENT WAS LEFT APHAKIC. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 24318642 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE DURING SURGERY WHEN USING THE PRELOADED INTRAOCULAR LENS (IOL). THE CAPSULE WAS TORN, REPORTEDLY NOT DUE TO THE LENS. THE LENS WAS CUT AND A 3-PIECE IOL WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24241896 ↗
• MalfunctionJan 14, 2026Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE INJECTING THE INTRAOCULAR LENS. UPON INSPECTION, THE LENS WAS FOUND TO BE DAMAGED AND ADHERED TO THE CARTRIDGE WALL. AFTER REPLACING IT WITH A NEW LENS, THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT OR CONTACT WITH THE LENS DAMAGED LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072730 ↗
• MalfunctionJan 6, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH ON THE LENS OPTIC AFTER INSERTION. AS A RESULT, THE LENS WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ILL EFFECTS OR HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976572 ↗
• MalfunctionDec 30, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON OBSERVED A FIBER WHICH THEY WERE UNABLE TO REMOVE FROM THE PATIENT'S LEFT EYE AS THE FIBER APPEARED TO BE WITHIN THE FABRIC OF THE LENS. DUE TO THE RISKS OF REMOVAL, THE SURGEON OPTED TO LEAVE THE IOL IMPLANTED. THE PATIENT IS AWARE OF THE ISSUE. THE PATIENT'S VISION REMAINS EXCELLENT AS PER THE POST OPERATIVE CHECK UP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926376 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885548 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS BROKEN WHEN TRYING TO INJECT INTO THE EYE CAPSULE BAG. IOL WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795825 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED NEGATIVE DYSPHOTOPSIA SYMPTOMS FOLLOWING THE IMPLANTATION OF A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THE VISUAL SYMPTOMS WERE FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION AND PERSISTED FOR APPROXIMATELY SIX MONTHS AND TWO WEEKS. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH +21.0 DIOPTER. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. IT IS UNKNOWN IF ANY MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23779509 ↗
• MalfunctionDec 5, 2025Break; Break

  DURING THE PROCEDURE, IT WAS REPORTED THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS BROKEN AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON IOL, HOYA, THAT WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735501 ↗
• MalfunctionNov 20, 2025Scratched Material; Scratched Material

  IT WAS REPORTED AFTER THE LENS WAS IMPLANTED AND POSITIONED INSIDE THE EYE, A NOTICEABLE SCRATCH WAS FOUND AT THE EDGE OF THE LENS OPTIC. THE SURGICAL PROCEDURE WAS COMPLETE WITH LENS IMPLANTED. THE LENS IMPLANTATION WAS SMOOTH WITH NO OBSTRUCTION. HOWEVER, THE SCRATCH REMAINED CLEAR AND NOTICEABLE AFTER THE VISCOELASTIC WAS REMOVED. THE LENS REMAINED IMPLANTED IN THE EYE AND PATIENT HAD NO DISCOMFORT. 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 23606178 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT WAS FOUND THAT THE LENS WAS BROKEN. IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916578 ↗
• InjuryJul 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). POST-OPERATIVELY, PATIENT IS REPORTING BLURRY VISION, LIKE A FOG, AND BLACK DOTS, WHICH ARE AFFECTING HER ABILITY TO DRIVE AND VIEWING FAR AWAY, AS WELL AS CAUSING DIFFICULTY WITH READING. HER VISION HAS BEEN GREAT UP TO ABOUT A YEAR AGO. PATIENT'S PRIMARY DOCTOR INSTRUCTED HER TO BOOK AN APPOINTMENT TO HAVE A ONE (01) MINUTE LASER PROCEDURE TO "CLEAN THINGS UP." NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22601799 ↗
• MalfunctionJun 24, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED LENS HAD A LOADING ERROR, CAUSING THE LENS TO FOLD UP LIKE AN ACCORDION. THIS OCCURRED DURING HANDLING PRIOR TO INSERTION AND THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324861 ↗
• MalfunctionMay 19, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS EXPLANTED. THROUGH FOLLOW UP WE LEARNED THAT POST IMPLANTATION, THE SURGEON NOTICED A MARK/SCRATCH ON THE OPTIC SURFACE AND DECIDED TO REMOVE AND REPLACE THE IOL IN THE SAME PROCEDURE. THE SURGEON USED A BACK UP IOL WITH SERIAL NUMBER (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048972 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON FOUND A LARGE CRACK IN THE CRYSTAL OPTICAL AREA IN THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) BEFORE IMPLANTING INTO THE PATIENT'S EYE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748774 ↗