TECNIS IOL ZCB00 (REF ZCB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 05050474531772), received between Aug 25, 2016 and Aug 7, 2026 — classified as 44 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  It was reported that a non-preloaded monofocal intraocular lens (IOL) was inserted into the eye; however, upon insertion, the lens was observed to be cracked. As a result, the lens was removed during the same surgical procedure. The complaint device was discarded . No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184303 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A SCHEDULED CLINICAL STUDY VISIT, POSTERIOR CAPSULE OPACIFICATION (PCO) WAS OBSERVED IN THE SUBJECT¿S LEFT EYE FOLLOWING IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE EVENT WAS MANAGED WITH A YTTRIUM-ALUMINUM-GARNET (YAG) CAPSULOTOMY, WHICH WAS PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE EVENT DID NOT IMPACT THE SUBJECT¿S DAILY ACTIVITIES, AND THE SUBJECT FULLY RECOVERED. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IMPROVED FROM A PREOPERATIVE MEASUREMENT OF 20/40 TO A POSTOPERATIVE MEASUREMENT OF 20/16. THE REPORTED ISSUE INVOLVED BOTH OF THE PATIENT'S EYES. THIS REPORT PERTAINS TO THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25808351 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT AN ISSUE WITH THE HAPTIC OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IDENTIFIED, DESCRIBED AS BROKEN OR DETACHED; HOWEVER, THE EXTENT OF THE HAPTIC DAMAGE COULD NOT BE DETERMINED. NO FORCE WAS REPORTED DURING DELIVERY. THE FULLY IMPLANTED IOL WAS REMOVED FROM THE PATIENT¿S LEFT EYE AND SUCCESSFULLY REPLACED DURING THE SAME PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER POWER. NO PATIENT INJURY WAS REPORTED, AND NO UNPLANNED SURGICAL INTERVENTIONS OR MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS FINE AND NO ADDITIONAL SURGICAL INTERVENTIONS ARE PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399480 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24336632 ↗
• 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 SINISTER (LEFT 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 23712495 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT SURGEON FOUND LENS BROKEN DURING THE INJECTION, RESULTING IN THAT THE SURGERY COULDN'T BE PERFORMED. THE SURGEON IMMEDIATELY REPLACED WITH OTHER LENSES. THE SURGERY WENT SMOOTHLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378208 ↗
• MalfunctionMay 19, 2025Contamination; Contamination

  SOME TYPE OF SPECK ON THE INTERNAL PART OF THE ZCB00 MODEL INTRAOCULAR LENS (IOL). THE DOCTOR VIGOROUSLY PERFORMED VISCOELASTIC REMOVAL AND TRIED TO CLEAN EVERYTHING OUT OF THE PATIENT'S EYE, BUT THE ITEM STILL REMAINED ON THE LENS. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS NOT REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048901 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS AN IRIS DEFECT. ONCE THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), THE LENS BAG BROKE, AND THE IOL NEEDED TO BE TAKEN OUT. INFORMATION ABOUT THE REPLACEMENT IOL IS UNKNOWN. SUTURES WERE REQUIRED AND A VITRECTOMY WAS PERFORMED. IT IS UNKNOWN IF THE INCISION WAS ENLARGED. THE PROCEDURE WAS DELAYED 1.5 HOURS. MEDICATIONS PRESCRIBED WERE KENALOG, MIOSTAT, AND DIAMOX. A PATCH & SHIELD WAS PLACED OVER THE PATIENT¿S OS. IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED, AND PATIENT STATUS POST PROCEDURE IS ALSO UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21749102 ↗
• InjuryMar 13, 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). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO A REFRACTIVE ERROR AND REPLACED WITH A ZLU300 23.0 DIOPTER IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21602388 ↗
• MalfunctionOct 7, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS HAD A SCRATCH ON THE LENS. IT WAS INITIALLY INSERTED INTO THE EYE BUT WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER J&J INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION SUGGESTS THAT THE PATIENT HAD AN EXCELLENT OUTCOME. THERE WERE NO ERRORS IN LOADING OR INSERTING THE LENS, HOWEVER, THE DEFECT ON THE IOL WAS NOTICED AFTER THE LENS UNFOLDED IN THE EYE. NO PATIENT INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385957 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT LEFT EYE DURING SAME PROCEDURE DUE TO HAPTIC BROKEN. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND VITRECTOMY WAS NOT REQUIRED. THE LENS WAS REPLACED WITH SAME J &J MODEL LENS. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531643 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED THAT TECNIS NON-PRELOADED INTRAOCULAR LENS WAS DAMAGED AND NOT USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671865 ↗
• MalfunctionApr 14, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OBSERVED TO BE BROKEN DURING INSERTION INTO THE PATIENT'S EYE. THE IOL WAS REMOVED FROM THE EYE. PATIENT STATUS PROVIDED AS TEMPORARILY IMPAIRED. VISION PRE-OPERATIVE: PERCEPTION OF LIGHT AND VISION POST-OPERATIVE: 6/36 PINHOLE 6/24. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748199 ↗
• InjuryMar 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE STICKING TOGETHER. THE MANEUVERS REQUIRED TO GET THE IOL OPEN WHICH GENERATED A CAPSULE RUPTURE. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Capsular Bag Tear

  MAUDE report 16482098 ↗
• MalfunctionJul 19, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, THE IOL WAS REMOVED DURING THE PROCEDURE AS THE SURGEON NOTICED A SCRATCH ON THE LENS AFTER INSERTION. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. IT WAS INDICATED THAT THE EVENT COULD BE DUE TO USE ERROR, HOWEVER, THE INFORMATION COULD NOT BE CONFIRMED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST OPERATION. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061040 ↗
• MalfunctionMay 26, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO BENT/BROKEN HAPTIC AND TORN IOL. REPLACEMENT LENS USED TO COMPLETE THE PROCEDURE WAS THE SAME JOHNSON & JOHNSON MODEL AND DIOPTER SIZE. THE 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 14519903 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANT CARD WAS RECEIVED WITH INDICATION THAT THE SUSPECT INTRAOCULAR LENS (IOL) WAS "IMPLANTED AND REMOVED/ WASTED". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 13546618 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON NOTICED A CAPSULE TEAR WHEN HE FULLY INSERTED THE INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. THE LENS WAS CUT UP, REMOVED AND DISCARDED. THE INCISION WAS ENLARGED AND VITRECTOMY WAS PERFORMED. A COMPETITOR'S LENS WAS USED AS THE REPLACEMENT AND A SUTURES WERE PLACED. THE PATIENT IS DOING WELL POST OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12829950 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) REMOVED AND REPLACED FROM THE EYE DUE TO ANISOMETROPIA. AT 1 DAY POST-OP: THE VISUAL ACUITY (VA) WERE : +0.50, +0.25. BY THE 7TH DAY POST-OP, THE (VA) WERE: +0.50, +0.25, AND AFTER 3 WEEKS, THE VA WERE: +0.50, +0.25. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11520764 ↗
• InjuryDec 4, 2020Adverse 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 FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT HAVING BLURRY VISION. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. ADDITIONAL DETAILS WERE RECEIVED STATING THAT THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS OF SAME MODEL BUT DIFFERENT DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10946495 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CAPSULE TEAR AS THERE WAS INADEQUATE SUPPORT WITH AN INTRAOCULAR LENS (IOL). THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 10729418 ↗
• MalfunctionSep 4, 2020Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE. IN THE PROCESS OF IOL IMPLANTATION, ONE SIDE OF THE LENS HAPTIC WAS STUCK. THE PHYSICIAN USED OPHTHALMIC MICRO TWEEZERS TO CLAMP THE STUCK LENS HAPTIC IN ORDER TO MAKE IT ENTER INTO THE PATIENT'S EYE. IT WAS INDICATED THAT THE OPERATION WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10497312 ↗
• MalfunctionJul 22, 2020Contamination; Contamination

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE, THE SURGEON FOUND WHITE MOLD ON THE LENS OPTIC. THE SURGEON REMOVED THE IOL FROM THE PATIENT¿S EYE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10306293 ↗
• InjuryJun 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC GOT CAUGHT ON THE CAPSULORRHEXIS AND WAS UNABLE TO MOVE DUE TO LOOSE ZONULES. IT WAS INDICATED THE LENS WAS OPENED AND NOT USED THUS INDICATING THE IOL WAS NOT IMPLANTED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THERE WAS NO DAMAGE TO THE OPTIC SURFACE OR LENS HAPTICS AFTER THE LENS WAS CAUGHT IN THE CAPSULORHEXIS. THE LENS DID NOT CONTRIBUTE TO LOOSE ZONULES AND THERE WAS NO UNPLANNED VITRECTOMY. UNPLANNED INCISION ENLARGEMENT WAS PERFORMED AND UNPLANNED SUTURE(S) WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10124821 ↗
• InjuryMar 25, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT¿S LEFT EYE. BUT PATIENT HAD HIGH INTRAOCULAR PRESSURE THAT DIDN'T ALLOW THE IOL TO SIT CORRECTLY IN THE EYE SO IT WAS REMOVED AND REPLACED. IT WAS STATED THERE WAS ALSO A CAPSULE TEAR, AND THE INCISION WAS ENLARGED. IT WAS LEARNED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Increased; No Code Available

  MAUDE report 9878863 ↗