TECNIS SIMPLICITY DCB00 (REF DCB0000160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474636002), received between Nov 11, 2020 and Nov 20, 2025 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 23610076 ↗
• MalfunctionAug 15, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING IMPLANT, PRELOADED INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE SCRATCH AND IT WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814418 ↗
• MalfunctionFeb 11, 2025Break; 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 21357826 ↗
• MalfunctionAug 3, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE MONOFOCAL PRELOADED INTRAOCULAR LENS HAPTICS WERE AMPUTATED AND WOULD NOT BE VIABLE FOR PATIENTS. THROUGH FOLLOW-UP, WE LEARNED THAT IT WAS ONLY THE INJECTOR WHICH TOUCHED THE EYE. NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452308 ↗
• MalfunctionJul 8, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A CRACK ON THE LENS. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283918 ↗
• MalfunctionJun 15, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) "WOULD NOT LOAD PROPERLY" IN THE CARTRIDGE, "STAYED FOLDED", AND WAS "TWISTED IN THE CARTRIDGE", WHICH WAS VISIBLE AND NOT ABLE TO BE USED FOR THE PATIENT. THE LENS WAS COMPLETELY FOLDED OVER AND STUCK TOGETHER IN THE CARTRIDGE; "IT WAS FOLDED BEFORE BEING PUSHED INTO TIP". IT WAS ALSO NOTED THAT THE HAPTIC WAS DAMAGED. THE ISSUE WAS NOTICED WHILE LOADING, PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. THE ISSUE WAS NOT DUE TO USE ERROR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND DIOPTER). BALANCED SALT SOLUTION (BSS) WITH NO ADDITIVES WAS USED AT ROOM TEMPERATURE AS A CARTRIDGE LUBRICANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136553 ↗
• MalfunctionApr 10, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE PRELOADED DEVICE MISFIRED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710638 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE LENS WAS NOT IMPLANTED BUT CONTAMINATED ON FILED WITH A BROKEN HAPTIC. THE PRODUCT HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14708426 ↗
• MalfunctionMay 26, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE, BUT THE LENS WAS IMPLANTED INTO PATIENT'S LEFT EYE. HOWEVER, THE SURGEON NOTICED A CRACK IN THE PRELOADED LENS AFTER IT WAS IMPLANTED INTO THE EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS OF DIFFERENT MODEL, BUT OF SAME DIOPTER WAS USED AS THE REPLACEMENT. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519429 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON NOTICED A CRACK IN THE PRELOADED LENS WHEN IT WAS IMPLANTED INTO PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED AND ANOTHER LENS OF DIFFERENT MODEL, BUT OF SAME DIOPTER WAS USED AS THE REPLACEMENT. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492522 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH CARE PROVIDER REPORTED THE INTRAOCULAR LENS (IOL) MIGHT HAVE CAUSED A TEAR IN THE EYE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW-UP THE CUSTOMER STATED IT IS LIKELY THAT THE CAPSULE TORE. THEY CONFIRMED THAT THE IOL WAS INSERTED BUT THEN REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. THE REPLACEMENT LENS IS ANOTHER JOHNSON & JOHNSON IOL OF A DIFFERENT MODEL AND DIOPTER (MODEL ZA9003, 15.0 DIOPTER). IT WAS NOTED THAT SUTURES WERE REQUIRED. REMOVED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14460170 ↗
• MalfunctionMay 12, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD LOADING ERROR AND THE LEADING HAPTIC WAS KINKED. THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED DURING HANDLING AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACKUP LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14385745 ↗
• MalfunctionOct 20, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TECNIS SIMPLICITY PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND WAS REMOVED DUE TO IT BEING SCRATCHED. A REPLACEMENT LENS OF MODEL DCB00, 16.0 DIOPTER WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669720 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO IS ALSO A DOCTOR, REPORTED THAT HE WAS IN A CAR ACCIDENT. HE HAD A CORNEAL TRANSPLANT BACK IN (B)(6). HOWEVER, JOHNSON & JOHNSON SURGICAL VISION (JJSV) RECORDS, PATIENT IMPLANT CARD INDICATE THE JJSV INTRAOCULAR LENS (IOL) WAS IMPLANTED IN (B)(6) 2021. THE PATIENT REPORTED THAT HE HAD A CORNEAL TRANSPLANT, STITCHES WERE INSTALLED, THE LENS WAS PUT IN AT THE SAME TIME AND THE TRAUMATIC CATARACT WAS REMOVED. THE PATIENT WAS INFORMED THAT HIS HEALING IS GOING VERY WELL. THAT BECAUSE HE LEADS A VERY HEALTHY LIFESTYLE, HIS HEALING WOULD BE FASTER THAN THE AVERAGE PERSON AND IT WOULD BE MAYBE 3-6 MONTHS BEFORE THE STITCHES WOULD BE REMOVED. WHEN THE STITCHES WERE REMOVED, THE DOCTOR TOLD THE PATIENT THAT HIS EYE LOOKED LIKE IT HAD BEEN HEALING FOR A YEAR. TWO MONTHS LATER THEY HAD 2/3 OF THE STITCHES REMOVED AND HIS DOCTOR SAID THERE WERE 3 LEFT THAT WOULD DISSOLVE IN ABOUT IN A MONTH. THAT WOULD HAVE BEEN IN (B)(6). THE DOCTOR SAID HIS VISION WOULD BE BLURRY. IN (B)(6), THE PATIENT'S VISION WAS NOT GETTING ANY BETTER, SO HE GOT A SECOND OPINION. THE DOCTOR TOLD HIM HE HAD 6 STITCHES AND UNDERNEATH THE LENS HE HAD SCAR TISSUE THAT THE DOCTOR WOULD NEED TO LASER OFF. THE PAT

  Patient problems: Blurred Vision; Deposits

  MAUDE report 12593452 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE EXAMINATION (SEVERAL DAYS AFTER SURGERY) REVEALED A REFRACTIVE ERROR (+4 ) DIOPTER SHIFT. THE INTRAOCULAR LENS (IOL) WAS REMOVED WITHOUT CUT AND ANOTHER LENS WAS INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12517005 ↗
• InjuryJul 13, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT'S EYE DUE TO ISSUE OF LABELLING CAUSING TO IMPLANT +16D LENS INSTEAD OF +26D LENS. PER ADDITIONAL INFORMATION RECEIVED THERE WAS NO WOUND ENLARGEMENT, NO SUTURES AND NO COMPLICATIONS. COMPETITIVE TORIC IOL WAS USED AS REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162848 ↗
• MalfunctionJun 10, 2021Break; Inaccurate Delivery; Mechanical Jam; Break; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT A DCB00 INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE AND HAD BENT/ BROKEN HAPTIC. LENS WAS STUCK IN CARTRIDGE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. PATIENT HAS RECOVERED. THIS EVENT WAS OBSERVED WHILE INSERTING LENS INTO PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980613 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) TORE INSIDE OF THE PATIENT'S EYE. VITRECTOMY WAS PERFORMED AND A REPLACEMENT LENS WAS PLACED DURING THE SAME PROCEDURE. THROUGH FOLLOW-UP IT WAS CLARIFIED THAT THE IOL TORE THE PATIENT'S EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11971323 ↗
• MalfunctionFeb 4, 2021Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A STRESS LINE ON THE SALT. THE LENS WAS FULLY INSERTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280643 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS COULD NOT BE ADVANCE THE AT FIRST AND FINALLY WHEN LENS WAS ADVANCED THE SURGEON DID NOT LIKE THE WAY THE LENS LOOKED. THERE WAS NO PATIENT CONTACT, PATIENT INJURY OR MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11061277 ↗
• MalfunctionDec 2, 2020Contamination; Contamination

  IT WAS INITIALLY REPORTED THAT THERE WAS FOREIGN BODIES FOUNDED UNDER THE OPTIC OF A TECNIS SIMPLICITY INTRAOCULAR LENS (IOL) AFTER IT WAS INSERTED INTO THE PATIENT'S LEFT (OS) EYE. THE SURGEON WAS ABLE TO VACUUM OUT THE SMALL PIECE, AND THE LENS REMAINS IMPLANTED. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10933171 ↗
• InjuryNov 11, 2020Break; Break

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS PARTIALLY DELIVERED INTO THE PATIENT EYE AND WAS THEN REMOVED. MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE PERFORMED. THE BACK-UP LENS USED WITH A DIFFERENT MODEL AND DIFFERENT DIOPTER LENS (AR40E 15.5D). THE PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. SUSPECT PRODUCT WILL NOT BE RETURNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10826502 ↗