TECNIS IOL ZCB00 (REF ZCB0000180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05050474531673), received between Oct 27, 2016 and Jun 25, 2026 — classified as 29 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO BOTH THE PATIENT¿S LEFT AND RIGHT EYE. THE DAY AFTER THE SURGERY THE PATIENT REPORTED SEEING RIDGES ON THE SIDES OF THE EYES LIKE BEVELED GLASS. THE PATIENT WAS INFORMED BY HER PHYSICIAN THAT SHE WAS SEEING THE SUTURES. THE PATIENT STATED THAT THE SYMPTOMS HAVE NOT GONE AWAY. SHE IS EXPERIENCING GLARE THAT MAGNIFIES LIGHT AND INTERFERES WITH HER VISION WHEN SHOPPING IN STORES AND GOING TO RESTAURANTS. PATIENT CAN DRIVE BUT SEES A HALF-MOON IN THE PREREFERRAL VISION ON THE OUTSIDE OF HER LEFT EYE. IT OBSTRUCTS HER VISION WHEN MAKING TURNS WHILE DRIVING. HER PHYSICIAN SAID IT WAS TOO RISKY FOR HER TO DRIVE AND THE PROCEDURE OCCURRED LONG AGO. ADDITIONALLY, SHE HAS TO MUCH CAR TISSUE FOR AN IOL EXCHANGE AND SHE WILL HAVE TO GET USED TO THIS. THE PHYSICIAN ALSO ADVISED HER TO SEE A DIFFERENT DOCTOR AT THE SAME PRACTICE BUT SHE DID NOT BECAUSE SHE DOES NOT HAVE CONFIDENCE IN THE RECOMMENDED DOCTOR. HOWEVER, THE PATIENT TRIED TO GET A SECOND OPINION AT A DIFFERENT FACILITY, (B)(6). REPORTEDLY, SHE WAS NOT ACCEPTED. THE PATIENT HAD A BRAIN ANEURISM SEVERAL YEARS AGO THAT DID NOT IMPACT HER VISION. T

  Patient problems: Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 25627003 ↗
• MalfunctionFeb 13, 2026Material Opacification

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD BLACK SPECKS. UPON OPENING THE IOL BOX, THE TECHNICIAN NOTICED A BLACK SPEC ON THE ACTUAL IOL. THE IOL DID NOT GET IMPLANTED, AND IT NEVER TOUCHED THE PATIENT¿S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339207 ↗
• InjuryDec 4, 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). ON (B)(6) 2024 POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED DURING SUBJECT YTTRIUM ALUMINUM GARNET (YAG) EVALUATION. THE PATIENT CAN PERFORM HER DAILY ACTIVITIES AS SHE DID PRIOR TO THE SURGICAL PROCEDURE. A YAG LASER CAPSULOTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2024. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20 AND POST-OPERATIVE WAS 20. PATIENT PROGNOSIS WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23712583 ↗
• MalfunctionSep 18, 2025Break; Break

  THE HAPTIC OF THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS TORN/BROKEN; THE HAPTIC LOOKED IRREGULAR. AS A PRECAUTIONARY MEASURE, THE CUSTOMER OBTAINED A NEW IOL. EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092598 ↗
• MalfunctionAug 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) OF A PATIENT. THE LENS WAS REMOVED DURING THE SAME PROCEDURE DUE TO THE PRESENCE OF A FIBER EMBEDDED IN IT. A DIFFERENT LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874760 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS INDENTED FROM THE SHOOTER. THERE WAS A HOLE IN THE BOTTOM OF THE CARTRIDGE. THE LENS WAS FULLY INSERTED AND REMOVED AND REPLACED WITH THE SAME MODEL LENS AND SAME DIOPTER IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE IOL LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551821 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE MONOFOCAL NON PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN. ISSUE WAS OBSERVED AFTER IMPLANTATION OF THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428953 ↗
• MalfunctionAug 2, 2024Break; Break

  IT WAS REPORTED THE NON PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS CRACKED. THERE WAS PATIENT CONTACT WITH THE IOL HOWEVER, THE EXTENT IS UNKNOWN. THE SUSPECT 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 19901060 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS DAMAGED AND NOT IMPLANTED. THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459567 ↗
• MalfunctionJan 27, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE AND REPLACED DURING THE SAME PROCEDURE AS IT HAD FOLDING ISSUE. ACCOUNT PROVIDED THAT THE IOL CAME OUT AT A WEIRD ANGLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13371167 ↗
• InjuryJan 19, 2022Adverse 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 THE LEFT EYE DUE TO BLURRY VISION. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS 20/80 -1. THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/20. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT IS VERY HAPPY WITH THE OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13290307 ↗
• MalfunctionNov 19, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC WAS MISSING. THE TEMPORAL HAPTIC WAS NOT ATTACHED TO THE LENS. THE EVENT MAY POSSIBLY BE RELATED TO USER ERROR. THERE WAS PATIENT CONTACT IN THE RIGHT EYE. THE LENS WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844915 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS REMOVED IMMEDIATELY AFTER IMPLANT AS THE CAPSULE TORE AND THE SURGEON HAD TO PERFORM A VITRECTOMY. IT WAS REPORTED THAT NOTHING WAS WRONG WITH THE LENS. ADDITIONAL CLARIFICATION WAS PROVIDED THAT THE CAPSULE TORE AFTER THE IOL WAS FULLY INSERTED, SO THE IOL WAS IMMEDIATELY REMOVED DURING THE SAME PROCEDURE. THE IOL WAS DISCARDED. IT WAS NOT KNOWN IF THE CAPSULE TEAR WAS ATTRIBUTED TO PATIENT ANATOMY ISSUE. A COMPETITOR'S 3-PIECE LENS WAS IMPLANTED AS A REPLACEMENT AND SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12572869 ↗
• MalfunctionSep 21, 2021Break; Break

  PATIENT IMPLANT CARD WAS RECEIVED INDICATING THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE IOL WAS PARTIALLY PLACED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND REMOVED DURING THE SAME PROCEDURE; THE DOCTOR DISCOVERED IOL WAS TOO BIG. ANOTHER JOHNSON & JOHNSON ZA9003 LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510861 ↗
• InjuryJun 15, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED BY DOCTOR ON THE PATIENT'S LEFT EYE AND HE DID NOT LIKE THE WAY IT WAS SPINNING. THERE WAS NO PATIENT INJURY. VITRECTOMY AND SUTURES WERE PERFORMED AND PROCEDURE WAS COMPLETED USING A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. PATIENT WAS DOING GREAT. SUSPECT PRODUCT WAS THROWN AWAY. ADDITIONAL DETAILS RECEIVED CONFIRMED THAT THE DOCTOR DID NOT LIKE THE WAY IT WAS SPINNING MEANT DIFFICULTY POSITIONING LENS INTO THE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005769 ↗
• MalfunctionMay 6, 2021Break; Break

  THE ACCOUNT REPORTED BROKEN LENS WITH AN INTRAOCULAR LENS. THERE WAS PATIENT CONTACT. IT WAS INDICATED THAT THE LENS WAS NOT RETURNED AS IT WAS WASTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785642 ↗
• MalfunctionApr 7, 2021Material Too Rigid or Stiff; Scratched Material; Material Too Rigid or Stiff; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR FELT THE INJECTOR A BIT STIFF AND HE PULLED BACK THE CARTRIDGE FROM PATIENT'S LEFT EYE. BEFORE ATTEMPTING FOR RE-INSERTION, DOCTOR NOTICED A CHIP IN THE LENS. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT ONLY THE CARTRIDGE TIP WAS INSERTED INTO THE EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND DIOPTER (SN (B)(4)). THE PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629183 ↗
• MalfunctionApr 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC BROKE OFF AND THERE WAS PATIENT CONTACT WITH THE LENS. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS IN THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628304 ↗
• InjuryJan 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED AND ATTEMPTED TO BE IMPLANTED IN A PATIENT¿S RIGHT EYE. HOWEVER, THE CAPSULAR BAG BROKE AND A VITRECTOMY WAS PERFORMED. THE LENS WAS INSERTED THEN REMOVED AND A 3-PIECE LENS OF A DIFFERENT MODEL (17.0 DIOPTER) WAS USED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY, NO POST OPERATIONAL ISSUES AND THE REPORTEDLY THE PATIENT DID WELL AFTER SURGERY. IT WAS INDICATED THAT THE PROBLEM WAS RELATED TO PATIENT ANATOMY. THE USED IMPLANT WAS DISCARDED AT THE CUSTOMER SITE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11144209 ↗
• InjuryApr 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT HE NOTICED A TEAR IN THE PATIENT'S CAPSULAR BAG ONCE A ZCB00 INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH A 3 PIECE NON-JOHNSON AND JOHNSON IOL. INCISION WAS ENLARGED ALONG WITH VITRECTOMY PERFORMED. IN ADDITION, SUTURES WERE USED TO COMPLETE THE PROCEDURE. THE CURRENT PATIENT STATUS WAS REPORTED AS DOING OKAY. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9951861 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9942126 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED FROM PATIENT'S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9918949 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCB00 INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF HYPEROPIC SHIFT AND DECREASED VISUAL ACUITY. THE REPLACEMENT LENS IS SCHEDULED TO BE A TECNIS 25.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9248577 ↗
• InjuryJul 31, 2019Break; Break

  IT WAS REPORTED THAT A MODEL ZCB00 INTRAOCULAR LENS (IOL) WAS DEFECTIVE WHILE INSERTING INTO THE EYE. IT WAS NOTED THAT THERE WAS ALSO INCISION ENLARGEMENT. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8844400 ↗
• InjuryJul 24, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) OPTIC WAS STUCK IN THE WOUND DURING DELIVERY; THEREFORE, THE SURGEON REMOVED AND REPLACED WITH ANOTHER LENS INSTEAD OF REFOLDING THE LENS. INCISION WAS ENLARGED BUT NO HARM TO THE PATIENT. REPORTEDLY, PATIENT HAS RECOVERED FROM THE SURGERY. THE CUSTOMER ALSO INDICATED THAT THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8820983 ↗