TECNIS IOL ZCB00 (REF ZCB0000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05050474531833), received between Sep 2, 2016 and Nov 6, 2025 — classified as 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT A PATIENT WITH A ZCB00 MODEL INTRAOCULAR LENS (IOL) IMPLANTED IN 2018 HAS IOL OPACIFICATION. THROUGH FOLLOW-UP, WE LEARNED THAT NO VITRECTOMY OR SUTURES WERE REQUIRED DURING IMPLANTATION AND THERE WAS NO DELAY IN PROCEDURE. THE ACCOUNT INDICATED THAT THE INITIAL POSTOPERATIVE PERIOD DID NOT PRESENT COMPLICATIONS, WITH VISUAL ACUITY OF 20/20 MAINTAINED FROM 2018 TO 2025. THE PATIENT WAS EXAMINED ON (B)(6) 2025, THERE WAS PARTIAL OPACIFICATION OF THE IOL WITH A MILD REDUCTION IN TRANSPARENCY AND A SLIGHT DECREASE IN VISUAL ACUITY. NO SIGNS OF INFLAMMATION, DISPLACEMENT, OR ADVERSE REACTION WERE REPORTED. THE IOL REMAINS IMPLANTED. THE ACCOUNT ALSO REPORTED THAT THE PROBABLE CAUSE OF THE OPACIFICATION IS A PHYSICOCHEMICAL ALTERATION OF THE OPTICAL MATERIAL / MINERAL DEPOSITION (CALCIUM). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23492968 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) 26.0D POWER SIZE, WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND REPLACED WITH THE SAME MODEL BUT 3.5 LOWER DIOPTER SIZE POWER IOL DUE TO UNSPECIFIED INJURY. THE PATIENT STATUS INDICATED FULLY RECOVERED. FOLLOW UP WAS ASKED ABOUT THE VISUAL ISSUES AND RESPONSE STATED NOT APPLICABLE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES PERFORMED. DIRECTIONS FOR USE WAS FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20563021 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THERE WAS HAPTIC BENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321432 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEGATIVE DYSPHOTOPSIA WITH THE INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THE IOL WAS EXCHANGED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS FULLY RECOVERED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16812999 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE CUSTOMER DID NOT HAVE ANY FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029044 ↗
• MalfunctionAug 2, 2021Break; Break

  IT HAS BEEN REPORTED THAT DOCTORS COMPLAINED ABOUT A MICROCRACK FOUND AFTER IMPLANTATION OF THE LENS, DURING THE OPERATION. THE CRACK IS LOCATED PARALLEL TO THE PLACE OF TRANSITION OF THE HAPTICS TO THE OPTICS, NOT ON THE OPTICAL ZONE. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. MATERIAL NOT AVAILABLE FOR INVESTIGATION. NO PATIENT INJURY HAS BEEN REPORTED SO FAR. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264431 ↗
• InjuryFeb 18, 2020Break; Break

  IT WAS REPORTED THAT THE OPTIC OR HAPTIC OF THE INTRAOCULAR LENS (IOL) DID NOT FEEL SMOOTH. THE IOL WAS CUT OUT, REMOVED DURING THE SAME PROCEDURE FROM THE PATIENT'S RIGHT EYE. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. A VITRECTOMY WAS REQUIRED, HOWEVER, THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 9722595 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE, AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT LOWER DIOPTER (24.5). ADDITIONAL INFORMATION RECEIVED REPORTED VISUAL DISTURBANCE, UNEXPECTED POST-OP REFRACTION AND RESIDUAL MYOPIA IN THE RIGHT EYE (OD). AN INCISION ENLARGEMENT WAS PERFORMED AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8899425 ↗
• MalfunctionJun 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS DEBRIS OBSERVED ON THE INTRAOCULAR LENS. THERE WAS NO PATIENT CONTACT. THIS EVENT WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8717189 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN INSERTING AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE CAPSULAR BAG WAS UNSTABLE. THE IOL WAS CUT OUT, REMOVED DURING THE SAME PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. REPORTEDLY, THE INCISION WAS ENLARGED, HOWEVER, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8656853 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT HAPTIC ISSUE. REPORTEDLY THE PRODUCT WAS NOT IN CONTACT WITH PATIENT'S EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8431214 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG TORE WHILE A ZCB00 26.0 DIOPTER LENS WAS BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH AN AR40E 25.0 DIOPTER LENS DURING THE SAME SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WERE NO PROBLEMS DESPITE THE CAPSULAR TEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7807869 ↗
• InjuryJul 12, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCB00 +26.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE IN 2016, AFTER A NORMAL UNCOMPLICATED SURGERY. THE PATIENT RETURNED TO THE SURGEON IN (B)(6) 2018, COMPLAINING OF POOR VISION AND STRONG NOTICEABLE HALOS IN THE RIGHT EYE THAT HAVE INCREASED OVER TIME. REPORTEDLY, THE SURGEON INSPECTED THE LENS AND NOTICED TWO (2) PARALLEL PALE GREY/WHITE STRIPES ACROSS THE VISUAL AXIS OF THE LENS. HE HAS TRIED TO YAG (YTTRIUM ALUMINUM GARNET) THINKING IT WAS PCO (POSTERIOR CAPSULAR OPACIFICATION) BUT THIS WAS INEFFECTIVE AND HE THINKS THE STRIPES ARE ACTUALLY INTEGRATED IN THE LENS SO NOT PCO. AS THIS IS THE PATIENT'S ONLY FUNCTIONAL EYE, HE IS RELUCTANT TO REMOVE THE LENS UNLESS ABSOLUTELY NECESSARY. FURTHER FOLLOW UP WITH THE SURGEON ON (B)(6) 2018, REPORTED THAT THE LENS IS STILL IN THE EYE. THE SURGEON INDICATED HE WAS PLANNING TO REFER THE PATIENT TO ANOTHER ANTERIOR CHAMBER SPECIALIST FOR REVIEW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 7684134 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (MODEL ZCB00) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE, THE SURGEON NOTICED A DAMAGED SPOT ON THE OPTIC EDGE. ACCORDING TO THE ACCOUNT, THE LENS WAS CAREFULLY EXAMINED AND LOADED CORRECTLY IN THE CARTRIDGE, BUT IT MUST HAVE GOT DAMAGED ON THE TIGHTEST PART OF THE CARTRIDGE BEFORE IMPLANTATION. REPORTEDLY, THE LENS REMAINS IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673859 ↗
• MalfunctionFeb 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK SPOT WAS NOTICED ON AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE ISSUE WAS REALIZED AS THE LENS WAS BEING PREPARED TO BE LOADED IN THE CARTRIDGE. THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7275769 ↗
• InjuryDec 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A REFLECTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT PERFORMED OR SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 25.0. ALSO, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7103004 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017 WITH USE OF A 1MTEC30 CARTRIDGE. POST-OPERATIVELY, ONE DAY AFTER SURGERY, THE DOCTOR DIAGNOSED THE PATIENT WITH HYPOPYON, FIBRIN MEMBRANE, SNOWSTORM, WHICH CLEARED QUICKLY ON INTENSE STEROIDS. IN ADDITION TO STEROIDS, THE PATIENT ALSO RECEIVED OMIDRIA. THE DOCTOR ALSO STATED THE PATIENT HAD SIGNIFICANT ENDOTHELIAL FOLDS-EDEMA, POSSIBLE TOXIC ANTERIOR SYNDROME (TASS), AND FIBRIN. THE CASE WAS ROUTINE - NOTHING OUT OF ORDINARY, THIS CASE SEEMED MORE C/W TASS LIKE PRESENTATION. NO IOL EXPLANT HAS BEEN OR WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE INTRAOCULAR LENS AND A SEPARATE REPORT WILL BE PROVIDED FOR THE CARTRIDGE.

  Patient problems: Edema; No Code Available

  MAUDE report 6982524 ↗
• MalfunctionMay 17, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DEBRIS ON THE INTRAOCULAR LENS (IOL). THE IOL DID NOT TOUCH THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6574332 ↗
• InjuryApr 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE AND FOR THE PATIENT REQUIRING A DIOPTER CHANGE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. ADDITIONALLY, THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6515062 ↗
• MalfunctionMar 29, 2017Break; Torn Material; Break; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TORE IN THE CARTRIDGE AND THE HAPTIC WAS BROKEN. REPORTEDLY, THE LENS TOUCHED THE PATIENT'S EYE. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443669 ↗
• InjurySep 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT THE WRONG LENS WAS IMPLANTED. THE ERROR WAS RECOGNIZED AND THE PATIENT WAS RE-PREPPED AND RE-DRAPED. THE WRONG LENS WAS REMOVED AND THE CORRECT LENS WAS IMPLANTED. THE INCORRECT LENS WAS LABELED ZCB00 (MONOFOCAL) AND THE CORRECT LENS FOR THE PATIENT WAS LABELED ZKB00 (MULTIFOCAL) AT THE SURGERY CENTER. UNFORTUNATELY, IN SPITE OF NUMEROUS CHECKS BY SEVERAL INDIVIDUALS INCLUDING THE OPHTHALMOLOGIST, NO ONE PICKED UP THE DISCREPANCY OF LENS TYPE (MONOFOCAL VERSUS MULTIFOCAL). PATIENT WAS DOING OKAY AFTER SURGERY BUT ON THE THIRD DAY POST-OP, PATIENT COULD ONLY COUNT FINGERS. VISION ON (B)(6) 2016 WAS 20/40 AND INTRA-OCULAR PRESSURE WAS 31. PATIENT HAD ACHING AND SORENESS. PATIENT WAS GIVEN COMBIGAN FOR THE EYE PRESSURE. ADDITIONALLY, AS THE INITIAL LENS WAS BEING REMOVED, THE LENS ENGAGED THE IRIS AND CAUSED SOME BLEEDING. THE PHYSICIAN OBSERVED THE EYE AND BLEEDING HAD STOPPED. NO VITRECTOMY WAS PERFORMED. HOWEVER, INCISION WAS ENLARGED TO REMOVE THE INITIAL LENS AND SUTURES WERE USED TO STITCH THE IRIS THAT TORE. AFTER THE SECONDARY PROCEDURE, THE AFFECTED EYE WAS AT 20/20 AND THE PRESSURE WAS AT 13 AT THE PATIENT'S POST OP VISIT ON (B)(6) 2016.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled; No Code Available

  MAUDE report 5927016 ↗