TECNIS IOL ZCB00 (REF ZCB0000140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474531598), received between Dec 30, 2016 and Jul 10, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SCHEDULED CLINICAL STUDY VISIT, POSTERIOR CAPSULE OPACIFICATION WAS OBSERVED IN THE SUBJECT¿S RIGHT EYE FOLLOWING IMPLANTATION OF A NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE ISSUE WAS MANAGED WITH YTTRIUM-ALUMINUM-GARNET (YAG) CAPSULOTOMY WHICH WAS PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE EVENT DID NOT IMPACT THE PATIENT¿S DAILY ACTIVITIES. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED. THE BEST CORRECTED VISUAL ACUITY (BCDVA) IMPROVED FROM PREOPERATIVE 20/30 TO POSTOPERATIVE 20/16. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25788477 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, POSTERIOR CAPSULAR OPACIFICATION (PCO) WAS OBSERVED IN THE PATIENT'S LEFT EYE. THE CONDITION WAS SUCCESSFULLY TREATED WITH A YAG CAPSULOTOMY. THE PATIENT FULLY RECOVERED WITH NO IMPACT ON ACTIVITIES OF DAILY LIVING. THE BEST-CORRECTED VISUAL ACUITY (BCVA) IMPROVED FROM 20/40 PREOPERATIVELY TO 20/20 POSTOPERATIVELY. THE COMPLAINT DEVICE REMAIN IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25769457 ↗
• MalfunctionJan 24, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD DEFECT ON THE CENTER OF THE LENS. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577123 ↗
• InjurySep 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A DISLOCATED IOL BAG COMPLEX. A PARS PLANA VITRECTOMY (PPV) WAS REQUIRED, HOWEVER, AN INCISION ENLARGEMENT WAS NOT REQUIRED. ALSO NOTED GONIOTOMY, YAMANE INTRASCLERAL HAPTIC FIXATION. THE PROCEDURE WAS COMPLETED WITH AN NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS EXCELLENT POST-OPERATIVE (OP). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 12454264 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE AND REMOVED DURING THE SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888602 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD HAPTIC BROKE IN THE CARTRIDGE WHILE BEING INJECTED IN THE PATIENT'S LEFT EYE. LENS DID TOUCH THE PATIENT. LENS WAS CUT OUT WITH NO DAMAGE AND WAS REPLACED. NO VITRECTOMY, SUTURES, ENLARGED INCISION, AND NO CAPSULE TEAR. NO POST-OP INJURIES ARE REPORTED AND A NEW LENS WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325761 ↗
• MalfunctionNov 13, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT MODEL OF THE INTRAOCULAR LENS (IOL) INSIDE THE BLISTER WAS WRONG. THE MODEL DESCRIBED ON THE BOX WAS ZCB00, HOWEVER, THERE WAS MULTIFOCAL LENS INSIDE THE BLISTER. THE LENS WAS IMPLANTED INTO PATIENT''S EYE. THE PATIENT HAD NO INDICATION TO USE THIS MODEL OF LENS, ONCE SHE HAD A FUX DYSTROPHY. THE PATIENT HAS J5 20/20 POST-OP VISION. AS PER THE SURGEON, A SECONDARY SURGERY/MEDICAL INTERVENTION WILL BE DONE, BUT THEY ARE STILL EVALUATING THE NECESSITY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10840876 ↗
• InjuryJan 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARTRIDGE WAS BROKEN. ADDITIONAL INFORMATION FROM FOLLOW UP STATES THAT AN NON-JOHNSON & JOHNSON ((B)(4)) CARTRIDGE WAS USED ALONG WITH JOHNSON & JOHNSON INTRAOCULAR LENS(IOL). THE LENS WAS PARTIALLY INSERTED INTO THE EYE. INCISION WAS ENLARGED TO REMOVE THE IOL FROM THE EYE. THERE WAS NO PATIENT INJURY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK UP LENS. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9630209 ↗
• InjuryDec 3, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE IN PATIENT'S EYE DURING INSERTION AND WAS REMOVED DURING SAME PROCEDURE. THE INCISION WAS ENLARGED. ANOTHER LENS, SAME MODEL AND DIOPTER WAS USED FOR THE REPLACEMENT. PATIENT REPORTED AS FINE POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9407618 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT HAPTIC WAS BROKEN DURING INSERTION OF TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00, +14.0 DIOPTER). THERE WAS PATIENT CONTACT WITH THE LENS. REPORTEDLY THE LENS WAS REPLACED WITH SAME MODEL AND +14.5, A LARGER DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO MEDICAL INTERVENTION. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8068187 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS TRYING OUT A SMALLER BLADE TO MAKE INCISION ENLARGEMENTS BEFORE CATARACT IMPLANTATION. THE DOCTOR INSERTED THE INSERTION SYSTEM, ENCOMPASSING A ZCB00 14.0 DIOPTER LENS, INTO THE ''SMALLER'' INCISION SITE AND AS THE LENS ADVANCED INTO THE PATIENT'S LEFT EYE (OS), THE LEADING HAPTIC CAUGHT CAUGHT ON THE INCISION SITE. THEREFORE, THE INSERTION SYSTEM/LENS WAS REMOVED, THE INCISION SITE WAS ENLARGED, AND THEN REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7793071 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 14.0 DIOPTER INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME SURGICAL PROCEDURE DUE TO THE PATIENT EXPERIENCING A RANT IN THE EYE/CAPSULAR TEAR. THE ACCOUNT COMMENTED THAT THERE WERE NO ISSUES WITH THE LENS. REPORTEDLY, THE LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7741848 ↗
• MalfunctionMay 17, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS SCRATCHED AND ALSO NOTED TO HAVE A DEFECT. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. THE LENS WAS REMOVED FROM PATIENT¿S OPERATIVE EYE WITHOUT PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521098 ↗
• MalfunctionAug 23, 2017Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE SIDE OF THE INTRAOCULAR LENS (IOL) WAS DENTED. THE ISSUE WAS NOTICED WHEN REMOVING THE IOL FROM THE PACKAGING. THERE WAS NO PATIENT CONTACT OR INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6815822 ↗
• MalfunctionJun 9, 2017Crack; Environmental Compatibility Problem; Crack; Environmental Compatibility Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CRACKED. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6628987 ↗
• MalfunctionDec 30, 2016Scratched Material; Scratched Material

  A SCRATCH ON A ZCB00 INTRAOCULAR LENS (IOL) WAS NOTICED AFTER IT WAS IMPLANTED. THE IOL WAS THEN REMOVED IN THE SAME PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6216742 ↗