TECNIS IOL ZCB00 (REF ZCB0000185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 05050474531680), received between Aug 29, 2016 and Feb 9, 2026 — classified as 30 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON- PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNKNOWN REASON. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24298362 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR AN UNKNOWN IOL IN THE LEFT EYE. THE REASON FOR THE EXPLANT REMAINS UNKNOWN. IT IS UNCLEAR WHETHER A PRODUCT PROBLEM, USE ERROR, OR PATIENT-RELATED SYMPTOMS WERE INVOLVED, AND WHETHER THOSE SYMPTOMS AFFECTED DAILY ACTIVITIES OR RESULTED IN A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY. NO PATIENT INJURY OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT OUTCOME WAS REPORTED AS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23466014 ↗
• MalfunctionSep 11, 2025Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  WHEN SETTING UP FOR PROCEDURE, IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS PACKAGED INCORRECTLY FROM THE FACILITY AND CAUSED THE LENS TO HAVE A DEFECT ALMOST LIKE SHARK BITES IN THE LENS. THE IOL WAS UNABLE TO BE USED FOR THE PROCEDURE AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028170 ↗
• MalfunctionJul 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT IN ITS CONTAINER BUT WAS LOOSE IN THE PACKAGING (OUTER BAG), AND THEREFORE IT WAS NOT LOADED. ACCOUNT CONFIRMED THAT THE IOL DID NOT COME INTO CONTACT WITH THE PATIENT. THROUGH FOLLOW-UP, WE LEARNED THAT THE STERILITY PROBLEM WITH THE LENS HAS BEEN PRESENT SINCE THE INTERNAL PACKAGE WAS REMOVED FROM ITS CONTAINER. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561780 ↗
• MalfunctionJul 8, 2025Break; Break

  THE ACCOUNT REPORTED EXPERIENCING DIFFICULTY IN FOLDING THE MONOFOCAL INTRAOCULAR LENS (IOL) AND IDENTIFIED AN ISSUE WITH HAPTIC MALFORMATION. IT WAS INDICATED THAT THE SURGERY COMPLETED IN SAME PROCEDURE. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22450427 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN IOL OF THE SAME MODEL, BUT LOWER DIOPTER (15.5D). NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22401041 ↗
• InjuryMar 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S RIGHT EYE. THE CUSTOMER REPORTED THAT THE IOL WAS PARTIALLY INSERTED BUT ALSO INDICATED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. IN ABUNDANCE OF CAUTION THIS EVENT IS BEING REPORTED AS THE IOL FULLY INSERTED AND THEN REMOVED. REPORTEDLY, UNPLANNED SUTURES WERE REQUIRED. THERE WERE NO DELAYS IN THE PROCEDURE. THE PATIENT¿S STATUS WAS REPORTED AS ¿FULLY RECOVERED¿. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692932 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED, THE PATIENT'S CAPSULE WAS TORN/BAG WAS OPEN. THE DOCTOR IS UNSURE WHY THE EVENT OCCURRED. THE IOL WAS REMOVED AND REPLACED WITH A 3-PIECE AR40E 17.0 DIOPTER IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT HAS BEEN REFERRED TO ANOTHER FACILITY FOR VITREOUS PROLAPSE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 19249241 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE, THE DOCTOR NOTICED PIECES OF LENS MATERIAL ON THE IOL CASING. FURTHER INSPECTION REVEALED THAT THE EDGE OF THE LENS WAS CRUSHED. THE IOL REMAINS IMPLANTED. THE PATIENT IS REPORTEDLY DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167778 ↗
• MalfunctionJun 19, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD SCRATCHES ON THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159908 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE AS THE PATIENT HAD AN UNSTABLE CAPSULE, THEREFORE, THE SURGEON WANTED A DIFFERENT LENS. THE INCISION WAS NOT ENLARGED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT HAS RECOVERED. THE LENS WAS DISCARDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16401409 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THE ZCB00 INTRAOCULAR LENS (IOL) WAS DAMAGED DURING THE PROCEDURE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955197 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULE WAS UNABLE TO HOLD THE INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13361739 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS DAMAGED AND THE IOL WAS CUT AND REMOVED FROM THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IT WAS INDICATED THAT THE IOL IS NOT BEING RETURNED FOR EVALUATION. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AT ONE WEEK POST-OP 20/25 VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006961 ↗
• MalfunctionSep 29, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551159 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT EYE DUE TO THE SURGEON NOTICING A SLIGHT TEAR ON THE CAPSULE. THE IOL WAS REPLACED WITH ANOTHER LENS OF DIFFERENT MODEL DURING THE SAME PROCEDURE. THE PATIENT HAS REPORTEDLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12443418 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAD BEEN PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE WHEN IT WAS FOUND THAT THERE WAS A BENT/BROKEN HAPTIC. PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168096 ↗
• MalfunctionJul 14, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THERE WAS A SCRATCH ON THE INTRAOCULAR LENS (IOL) AND THERE WAS PATIENT CONTACT. THE IOL WAS REMOVED FROM THE PATIENT¿S OPERATIVE EYE AND A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS SUCCESSFULLY INSERTED. THERE WAS NO PATIENT INTERVENTION, NO SUTURES, AND NO VITRECTOMY. THE LENS WAS DISCARDED AND IS NOT BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164519 ↗
• MalfunctionMar 26, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL), THE SURGEON REALIZED THAT THERE WAS A MARK IN THE CENTER OF THE LENS. HE THEN HAD TO REMOVE THE IOL AND IMPLANT ANOTHER ONE DURING THE SAME SURGERY. THE SUSPECT IOL WAS DISPOSED OF IN THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576679 ↗
• MalfunctionFeb 3, 2021Difficult to Fold, Unfold or Collapse; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Advance

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED LENS IN THE PATIENT'S RIGHT EYE, BUT WAS THEN REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO FOLDING ISSUE AND HAVING PROBLEM WITH THE UNFOLDER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND SAME DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274565 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED POST-OP INFECTION AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. FURTHER FOLLOW-UP STATED THAT THE CUSTOMER ¿S FACILITY HAS A TOXIC ANTERIOR SEGMENT SYNDROME (TASS) OUTBREAK AND A THOROUGH INVESTIGATION IS BEING DONE BUT A KNOWN CAUSE HAS NOT YET BEEN CONFIRMED. FOR THIS EVENT OUR IOL AND HEALON ENDOCOAT FOR DUET WERE INDICATED AS SUSPECT PRODUCTS. HOWEVER, IT WAS STATED THAT STEROID DROPS WERE GIVEN TO THE PATIENT AS MEDICAL INTERVENTION. THE PATIENT FULLY RECOVERED WITH THE IOL REMAINING IMPLANTED. NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR SUSPECT IOL. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE SUSPECT HEALON ENDOCOAT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11206113 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE RIGHT EYE OF A PATIENT WHICH WAS IMPLANTED WITH AN INTRAOCULAR LENS. THE EVENT OCCURRED FIRST DAY POST OPERATION. POST OPERATIONAL DROPS GIVENT TO THE PATIENT WERE BESIVANCE, PROLENSA. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POST-OP MEDICATIONS WERE DUREZOL / BESIVANCE/ILEVRO. IT WAS CONFIRMED THAT THE PATIENT HAS PATIENT RECOVERED AND NO PATIENT INJURY WAS REPORTED. THE LENS REMAINS IMPLANTED AND THE HEALON PRODUCT IS NOT AVAILABLE FOR RETURN. THE SURGERY CENTER INDICATED THAT THEY FULLY INVESTIGATED THE ISSUE; HOWEVER, THE CAUSE IS UNDETERMINED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR IS FOR THE SUSPECT INTRAOCULAR LENS, MODEL ZCB00. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HEALON ENDOCOAT DUET.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11205852 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A VITRECTOMY. THE INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 10858185 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE A CAPSULE TEAR/COLLAPSE IN THE LEFT (OS) EYE AFTER INSERTION OF A MODEL ZCB00 TECNIS INTRAOCULAR LENS (IOL). THE SURGEON REMOVED AND REPLACED WITH A MODEL ZA9003 LENS DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 10446732 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9455916 ↗