TECNIS IOL ZCB00 (REF ZCB0000240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05050474531796), received between Aug 25, 2016 and Apr 21, 2026 — classified as 38 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 69 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT TWO NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE ATTEMPTED BUT NOT IMPLANTED IN THE PATIENT¿S LEFT EYE (OS), RESULTING IN THE PATIENT LEAVING SURGERY APHAKIC. INITIALLY, AN ATTEMPT WAS MADE TO IMPLANT A ZCB00 MODEL LENS IN THE SULCUS OF THE LEFT EYE AND THE LENS WAS FULLY INSERTED; HOWEVER, THE IOL WAS UNSTABLE IN SULCUS AND THE ZONULES WERE NOTED TO BE UNSTABLE/LOOSE. AS A RESULT, THE LENS WAS REMOVED AND AN UNPLANNED ANTERIOR VITRECTOMY WAS PERFORMED. THE PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS REPORTED AS 20/25-3. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO IMPLANT AN AR40E LENS AS AN ANTERIOR CHAMBER IOL (ACIOL) IN THE LEFT EYE. DURING THIS ATTEMPT, PATIENT MOVEMENT OCCURRED AND AN IRIS DIALYSIS WITH SPHINCTER TEAR WAS REPORTED. THE IOL WAS REMOVED, AND NO ADDITIONAL INTERVENTIONS WERE PERFORMED. NO REPLACEMENT IOL WAS IMPLANTED, AND THE PATIENT WAS SENT HOME APHAKIC. ALTHOUGH SUTURES WERE INITIALLY INDICATED, FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT NO ADDITIONAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LENS MODEL ZCB00. A SEPARATE REPORT WILL BE SUBMITTED FOR THE AR40E MODEL

  Patient problems: Zonular Dehiscence

  MAUDE report 24948364 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE INVOLVING A ZCB00 MODEL INTRAOCULAR LENS (IOL) A VITRECTOMY WAS PERFORMED AND THE LENS WAS CHANGED. THERE WAS PATIENT CONTACT. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22378935 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED WITH AN ANOTHER COMPANY IOL DURING A SECONDARY SURGICAL PROCEDURE. NO INJURY OR INTERVENTION WAS REPORTED AND THE PATIENT FULLY RECOVERED. PERSONAL INFORMATION CANNOT BE PROVIDED DUE TO DATA PRIVACY REGULATIONS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21021178 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS DAMAGED. THE IOL WAS NOT IN A CONDITION FOR IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696151 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSTERIOR CAPSULE TEAR. IOL HAD TO BE REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19102268 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE IS NO INFORMATION ABOUT THE REPLACEMENT IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617148 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD BENT HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314867 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE LENS WAS STUCK IN THE CARTRIDGE. THERE WAS NO CONTACT WITH THE PATIENT'S EYE. A REPLACEMENT LENS WAS USED AND THE ZCB00 LENS THAT WAS USED LED TO A POSTERIOR CAPSULE RUPTURE. AS A RESULT OF THE COMPLICATION, A POSTERIOR VITRECTOMY WAS PERFORMED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17889863 ↗
• MalfunctionAug 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) AS INSERTED AND REMOVED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) IN THE SAME PROCEDURE; THUS NOT IMPLANTED. THE REASON FOR THE IOL REMOVAL WAS NOT SPECIFIED. IT IS UNKNOWN IF ANOTHER IOL WAS IMPLANTED INTO THE PATIENT'S OS AND PATIENT STATUS POST-PROCEDURE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626593 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED DUE TO A HAPTIC MALFUNCTION. FOLLOW-UP WAS DONE BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066382 ↗
• MalfunctionMay 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED INTO THE PATIENT´S EYE, THE SURGEON NOTICED, THAT THE TRAILING HAPTIC WAS CUT OFF. IT TOOK HIM A WHILE TO CUT THE IOL INTO SMALLER PIECES TO REMOVE IT BEFORE IMPLANTING A NEW LENS. THE SURGEON DID NOT FEEL ANY DIFFERENCE WHEN SCREWING THE LENS FORWARD COMPARED TO OTHER IOL'S, NO RESISTANCE AT ALL. THE PHYSICIAN FOLLOWED THE DIRECTIONS FOR USE (DFU). NO DETAILS ON THE PATIENT OUTCOME SINCE NO POST-OPERATIVE CHECK HAS TAKEN PLACE. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925009 ↗
• MalfunctionApr 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE PHYSICIAN DID NOT LIKE HOW THE ZCB00 INTRAOCULAR LENS (IOL) WAS SITTING IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) AFTER THE IOL UNFOLDED SO HE REMOVED IT. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED. THERE WAS NO PATIENT INJURY HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL AND/OR MEDICAL INTERVENTION. PATIENT STATUS POST-OPERATIVELY WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718031 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED ZONULYSIS IN THEIR OPERATIVE EYE POST INTRAOCULAR LENS (IOL) IMPLANTATION. THE IOL WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 16621870 ↗
• MalfunctionMar 15, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT ZCB00 INTRAOCULAR LENS WAS INSERTED AND REMOVED FROM THE PATIENTS RIGHT EYE DUE TO LOADING ISSUE. THE LENS WAS TORN. PATIENT HAS RECOVERED. THE LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16547760 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPIRED/DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547005 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, THE LENS WAS REMOVED AS THE POSTERIOR CAPSULE OPENED AND REPORTED CAPSULE TEAR/COLLAPSE. THE INCISION WAS ENLARGED AND VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15492021 ↗
• MalfunctionMay 26, 2022Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DOCTOR HAD A SECOND CONSECUTIVE CASE (FIRST CASE WAS THE FIRST EYE OF THE SAME PATIENT THE PREVIOUS WEEK) OF INTERNAL AND CENTRAL RUPTURE OF THE LENS WHEN INJECTING THEM IN THEIR OWN CARTRIDGE AND INJECTOR. BOTH NEEDED TO BE REMOVED AND REPLACED. THEY HAVE NOT HAD ANY MORE CASES LIKE THESE TWO BUT FIND THAT HAVING TWO CONSECUTIVE INCIDENTS IS NOT NORMAL. THROUGH FOLLOW-UP WE LEARNED THAT THE DOCTOR NOTICED ANOMALIES WHEN IMPLANTING THE LENSES, SPECIFICALLY AN AXIS-TO-AXIS TRANSVERSAL LINE. AS A RESULT, SHE REMOVED THE LENSES AND IMPLANTED NEW ONES. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR THE SECOND EYE. A SEPARATE REPORT IS BEING FILED FOR LENS (B)(4) (FIRST EYE OF THIS SAME PATIENT. EVENT DATE (B)(6) 2022).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14505563 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED INTO THE UNFOLDER AND INSERTED INTO PATIENT'S LEFT EYE. HOWEVER, AS WITHDRAWING THE UNFOLDER, THE HAPTIC BROKE. THE LENS WAS REMOVED FROM THE EYE AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079419 ↗
• InjuryDec 27, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM PATIENT'S RIGHT EYE AS THE LENS STARTED TO FALL TO THE BACK OF THE EYE. ACCOUNT INDICATED THAT THE CAPSULAR BAG WAS UNSTABLE AND THE SURGEON HAD TO USE A 3 PIECE LENS. HENCE, A COMPETITOR LENS WAS USED AS THE REPLACEMENT IOL TO COMPLETE THE SURGERY. NO OTHER INTERVENTION WAS REQUIRED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 13091156 ↗
• MalfunctionDec 10, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT AN INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED AND HAPTIC WAS BENT. THE EVENT WAS OBSERVED WHILE INSERTING LENS INTO PATIENT'S RIGHT EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE DONE. PATIENT WAS DOING WELL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980101 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12485707 ↗
• MalfunctionAug 9, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) MODEL ZCB00 WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO LENS BEING SCRATCHED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298450 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS(IOL), MODEL ZCB00, WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT HAVING TOO MUCH MYOPIC OUTCOME. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES PERFORMED. THE REPLACEMENT LENS WAS OF THE SAME MODEL BUT DIFFERENT DIOPTER. PATIENT WAS REPORTEDLY DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12243015 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS DAMAGED DURING INSERTION OF LENS. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196411 ↗
• MalfunctionJul 14, 2021Break; Material Fragmentation; Inaccurate Delivery; Break; Material Fragmentation; Inaccurate Delivery

  IT WAS REPORTED THAT A TECNIS ONE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) GOT STUCK IN THE INCISION OF THE PATIENT'S LEFT EYE, AND THE HAPTIC BROKE OFF. NO SUTURES OR VITRECTOMY WERE REQUIRED. THE LENS WAS REPLACED WITH A SAME MODEL AND DIOPTER LENS. THE PATIENT IS FINE POST-OP. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169891 ↗