TECNIS IOL ZCB00 (REF ZCB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 05050474531741), received between Aug 25, 2016 and Sep 21, 2026 — classified as 46 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 103 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Bag Tear

  MAUDE report 50847404 ↗
• MalfunctionJun 5, 2026Ejection Problem

  IT WAS REPORTED THAT THE A SINGLE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INCORRECTLY INTO THE EYE AND REQUIRED REMOVAL, FOLLOWED BY RELOADING OF ANOTHER LENS. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414797 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, IN THE PATIENT¿S RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25352637 ↗
• InjuryFeb 9, 2026Adverse 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 REFRACTIVE ERROR. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL OF HIGHER DIOPTER 23.0D. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24300131 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS(IOL) WAS INSERTED. AFTER INSERTION, THE HAPTICS WERE NOTED TO BE DISTORTED AND THE IOL OPTIC COULD NOT BE CENTERED. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER INTRAOCULAR LENS (MODEL UNKNOWN) DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND SUTURED. THE PATIENT RECOVERED FULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751087 ↗
• MalfunctionNov 24, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH IDENTIFIED ON IT AFTER IMPLANTATION INTO THE PATIENT'S EYE. THE IOL WAS EXPLANTED DURING THE SAME PROCEDURE. A BACKUP LENS WAS UTILIZED TO COMPLETE THE PROCEDURE, WHICH RESULTED IN A DELAY. THE ACCOUNT CONFIRMED THAT THE INCISION WAS NOT ENLARGED, NO VITRECTOMY OR SUTURES WERE REQUIRED. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640288 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO DYSPHOTOPSIA. THE LENS WAS REMOVED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER DURING THE SECONDARY SURGICAL PROCEDURE. UNPLANNED SUTURES WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22158305 ↗
• MalfunctionMay 19, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS HAD A SCRATCH ON IT NEAR THE HAPTIC-OPTIC JUNCTION. IT WAS REMOVED AND REPLACED WITH A BACKUP IOL OF THE SAME TYPE AND POWER. THERE WAS NO PATIENT INJURY AND THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049030 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DECENTRALIZED BECAUSE OF ZONULYSIS. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21886179 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). FOR UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 19.0 DIOPTER IOL. THERE IS NO INDICATION OF MEDICAL INTERVENTION OR SURGICAL INTERVENTION DURING THE EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21506133 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POSTERIOR CAPSULE RUPTURE (PCR) AFTER MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) INSERTION. IOL WAS CHANGED. THERE WAS DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21203270 ↗
• MalfunctionAug 22, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THERE WAS SOMETHING ON THE SURFACE OF THE NON PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) AND THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT INJURY AND NO SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034015 ↗
• MalfunctionAug 13, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) GOT STUCK IN THE INCISION OF THE PATIENT'S LEFT EYE, IOL REMOVED AND ENLARGED THE INCISION PUT NEW LENS IN. SURGEON ASKED FOR A SECOND LENS SAME DIOPTER. SURGERY COMPLETED SUCCESSFULLY USING BACK-UP IOL. NO PATIENT HARM. NO OTHER INFORMATION PROVIDED.

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

  MAUDE report 19977415 ↗
• MalfunctionJun 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) HAPTIC BROKE OFF/DETACHED WHILE IN THE 1MTEC CARTRIDGE AND THE IOL WAS PARTIALLY INSERTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP ZCB00 21.5 DIOPTER IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION PERFORMED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534393 ↗
• MalfunctionMay 22, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH WHICH WAS NOTICED AFTER INSERTION INTO THE PATIENT'S LEFT EYE. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH THE SAME MODEL LENS OF HIGHER DIOPTER. THERE WAS NO INJURY REPORTED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING WELL. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376177 ↗
• MalfunctionNov 29, 2023Device Difficult to Setup or Prepare; Operating System Becomes Nonfunctional; Device Difficult to Setup or Prepare; Operating System Becomes Nonfunctional

  IT WAS REPORTED UPON IMPLANTATION THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED, THERE WAS A LOT OF RESISTANCE WHILE TRYING TO INJECT AND THE PLUNGER WOULDN'T ADVANCE CORRECTLY. THE IOL WAS CUT OUT AND THE PROCEDURE WAS COMPLETED USING A BACK-UP LENS WITH THE SAME DIOPTER. THERE WAS NO PATIENT INJURY AND THE CASE PROCEEDED AS PLANNED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235111 ↗
• MalfunctionNov 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED UPON IMPLANTATION THE MODEL ZCB00 INTRAOCULAR LENS (IOL) WAS DAMAGED, THE PLUNGER WENT UNDER THE LENS AND WOULD NOT ADVANCE. THE IOL WAS CUT OUT AND THE PROCEDURE WAS COMPLETED USING A BACK-UP LENS WITH THE SAME DIOPTER. THERE WAS NO PATIENT INJURY AND THE CASE PROCEEDED AS PLANNED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235081 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOCULAR INTRAOCULAR LENS (IOL) WITH MODEL ZCB00 HAD A CAPSULAR BAG RUPTURED UPON PLACEMENT IN THE EYE. THE LENS WAS REMOVED. A VITRECTOMY WAS REQUIRED. A NEW LENS (ZA9003) WAS INSERTED AND SUTURES WERE REQUIRED. THE PATIENT WAS SHIFTED TO THE RECOVERY ROOM WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED AND IT WAS LEARNT THAT THE SURGERY PROCEEDED NORMALLY WITH LENS REMOVAL. THE CAPSULAR BAG WAS REINFLATED WITH VISCOELASTIC AND THE CAPSULAR BAG WAS INTACT. THE ZCB00 LENS WAS PLACED IN THE EYE USING A SHOOTER AND ALLOWED TO UNFOLD IN THE CAPSULAR BAG. THE INSERTER WAS NOT ADVANCED INTO THE ANTERIOR CHAMBER. A KUGLEN HOOK WAS USED TO PUSH THE TRAILING HAPTIC FROM THE ANTERIOR CHAMBER INTO THE CAPSULAR BAG AND A TEAR IN THE POSTERIOR CAPSULE WAS SEEN WITH THE LEADING HAPTIC GOING THROUGH THE TEAR. IOL WAS BROUGHT BACK INTO THE ANTERIOR CHAMBER AND REMOVED FROM THE EYE BY CUTTING EACH LENS INTO THREE PIECES. LENS WAS REPLACED WITH A THREE-PIECE SULCUS LENS IN SAME SURGICAL PROCEDURE. THE PATIENT REQUIRED AN ANTERIOR VITRECTOMY THAT SAME DAY. PATIENT HAS BEEN REFERRED TO A RETINA SPECIALIST FOR EVALUATION BECAUSE OF THE ANTERIOR VITRECTOMY. APPOIN

  Patient problems: Capsular Bag Tear

  MAUDE report 17864997 ↗
• MalfunctionAug 15, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THERE WERE SURFACE SCRATCHES ON THE INTRAOCULAR LENS (IOL) WHILE INSERTING THE IOL INTO THE PATIENT'S EYE. THE IOL WAS ALSO BROKEN. THE IOL WAS REMOVED AND REPLACED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553042 ↗
• InjuryJul 24, 2023Break; Break

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, FOUND A CRACK IN THE MIDDLE OF IOL. IOL WAS REMOVED. THERE WAS 30 MINUTES OF DELAY IN THE PROCEDURE. MEDICATION WAS PRESCRIBED BUT REASON IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 17382461 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT STABLE AND THERE WAS A CAPSULE TEAR DURING ITS IMPLANTATION. THE IOL WAS THEREFORE REMOVED DURING THE SAME PROCEDURE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17295404 ↗
• MalfunctionJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED. THROUGH FOLLOW-UP WE LEARNED THAT THEY HAD TO REMOVE THE IOL BECAUSE THEY NOTICED A MAJOR ZONULAR DEFECT AND THE IOL WOULD NOT HAVE HELD. NO FURTHER DETAILS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 17243957 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED DURING THE SAME PROCEDURE. THE DOCTOR INSERTED THE LOADED IOL AND NOTED THE HAPTIC BROKE DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO MEDICAL INTERVENTION REQUIRED SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. THIS EVENT DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. REPORTEDLY, THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939048 ↗
• MalfunctionMar 8, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOLS) HAD DENTS; HOWEVER, THEY WERE IMPLANTED IN THE PATIENT'S EYE BECAUSE THE DEFECT WAS AT THE EDGE OF THE OPTICS AND SHOULD NOT AFFECT VISION. NO FURTHER INFORMATION RECEIVED. THIS REPORT IS FOR THE FIRST PATIENT INVOLVED OUT OF 3 PATIENTS TOTAL. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504763 ↗
• MalfunctionFeb 15, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO BENT/BROKEN HAPTIC. THE ISSUE WAS OBSERVED WHILE INSERTING THE IOL INTO THE EYE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383347 ↗