TECNIS IOL ZCB00 (REF ZCB0000160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474531635), received between Mar 30, 2017 and Sep 1, 2026 — classified as 25 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during implantation of a single-piece non-preloaded monofocal intraocular lens (IOL), the capsule broke. As a result, the doctor did not implant the reported lens and opted to use a AR40e lens model to complete the procedure. The event occurred during implantation/application. The product was not available for return for investigation. No further information was provided.

  Patient problems: Capsular Bag Tear

  MAUDE report 50553720 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, THE PATIENT EXPERIENCED A CAPSULAR RUPTURE WITH INADEQUATE CAPSULAR SUPPORT. A THREE-PIECE LENS WAS SUBSEQUENTLY USED, AND THE INCISION WAS CLOSED WITH 10-0 NYLON SUTURES. PATIENT CONTACT WAS MADE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24847773 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POSTERIOR CAPSULE OPACIFICATION WAS NOTED DURING (B)(6) 2024 YTTRIUM ALUMINUM GARNET (YAG) EVALUATION AND WAS RESOLVED BY PERFORMING YAG LASER CAPSULOTOMY ON (B)(6) 2024. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 24818222 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POSTERIOR CAPSULE OPACIFICATION WAS NOTED DURING (B)(6) 2024 YTTRIUM ALUMINUM GARNET (YAG) EVALUATION AND WAS RESOLVED BY PERFORMING YAG LASER CAPSULOTOMY THAT SAME DAY. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/25 AND POST-OPERATIVE WAS 20/20. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 24817930 ↗
• 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 A YTTRIUM ALUMINUM GARNET (YAG) EVALUATION AND A YAG LASER CAPSULOTOMY PROCEDURE WAS PERFORMED THAT DAY. THE PATIENT CAN PERFORM HER DAILY ACTIVITIES AS SHE DID PRIOR TO THE SURGICAL PROCEDURE. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 25 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 23712920 ↗
• 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 A 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 30 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 23712797 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, A POSTERIOR CAPSULE TEAR OCCURRED. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS SUBSEQUENTLY REMOVED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22396523 ↗
• MalfunctionNov 12, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A MARK. WHEN THE IOL WAS INSERTED IT WAS NOTICED THAT THERE WAS A MARK ON THE HAPTIC FROM THE INSERTION. THE DOCTOR DECIDED TO REPLACE IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667991 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE. REPORTEDLY THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER DUE TO DECREASED VISION AND OCULAR RISK. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20183851 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT¿S OPERATIVE EYE. THE IOL WAS INSERTED AND THEN REMOVED DUE TO A CAPSULE TEAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-JNJ 15.0 DIOPTER LENS. DOCTOR THINKS HE MAY HAVE CAUSED THE CAPSULE TEAR AND NOT THE IOL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17909564 ↗
• MalfunctionJan 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AFTER OPENING A BOX CONTAINING AN INTRAOCUAR LENS (IOL), IT WAS FOUND THAT THE PACKAGING INSIDE WAS NOT WELL SEALED. THE DOCTOR DEEMED THE PRODUCT NO LONGER STERILE AND DID NOT USE THE IOL FOR SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13160432 ↗
• InjuryJul 27, 2021Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT WAS NOT SEEING CLEARLY WITH THE IMPLANT. THE INCISION WAS REOPENED AND SUTURE WAS USED AFTER THE REPLACEMENT LENS WAS PLACED INTO THE OPERATIVE EYE. THERE WAS NO INJURY AND PATIENT WAS DOING WELL POST OPERATIVELY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12235645 ↗
• MalfunctionJul 13, 2021Mechanical Problem; Mechanical Problem

  RECEIVED REPORT INDICATING THE MONOFOCAL INTRAOCULAR LENS (IOL) SEEMINGLY HAD DIFFRACTIVE RINGS. THERE WAS NO INTERVENTION SUCH AS, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE IOL WAS LEFT IMPLANTED AND THEREFORE WILL NOT BE RETURNED. PER THE CUSTOMER NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164128 ↗
• InjuryMar 18, 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 FROM PATIENT'S LEFT EYE AS THE PATIENT HAD LEFT OVER ASTIGMATISM AFTER CATARACT SURGERY. ALSO THE PATIENT HAS HAD BLURRY VISION AND HALOS RELATED TO ASTIGMATISM. PATIENT HAS KERATOCONUS. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. THERE WAS NO DELAY IN PROCEDURE. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL, DFR00V AND DIFFERENT DIOPTER 21.0 LENS. PATIENT IS HAPPY BUT STILL HEALING. PATIENT/USER OUTCOME: VISUAL ACUITY PRE-OP: UNCORRECTED 20/40. VISUAL ACUITY POST-OP: UNCORRECTED 20/25. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Impairment

  MAUDE report 11520836 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS GIVEN INCORRECT INTRAOCULAR LENS (IOL) WHICH HE INSERTED INTO PATIENT'S EYE. ONCE HE DISCOVERED IT WAS THE INCORRECT IOL, EXPLANT OF IOL WAS PLANNED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE SURGEON WAS HANDED A MONOFOCAL LENS WHEN HE WAS SUPPOSED TO BE GIVEN A MULTIFOCAL LENS. THE LENS THEN WAS EXPLANTED ON A DIFFERENT DATE AND REPLACED WITH ZCB00 SN (B)(4), NEVERTHELESS THE CONTACT PERSON DOES NOT KNOW OTHER INFORMATION SURROUNDING THE EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 11499613 ↗
• MalfunctionAug 20, 2020Contamination; Contamination

  IT WAS REPORTED AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, DEBRIS WAS OBSERVED ON THE LENS. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434194 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S POSTERIOR CAPSULE TORE. THERE WAS NO VITREOUS LOSS. A SULCUS LENS WAS PUT IN AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear

  MAUDE report 9297685 ↗
• InjuryOct 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED THAT HE HAD ZCB00 INTRAOCULAR LENSES IMPLANTS IN BOTH EYES. THE RIGHT EYE (OD) IMPLANT WAS PERFORMED (B)(6) OF 2017. THE LEFT EYE (OS) IMPLANT WAS DONE ON (B)(6) 2019 (2/7/2019). THIS REPORT REPRESENT THE LEFT EYE. PATIENT HAS FLOATERS IN BOTH EYES, BUT IT IS WORSE IN THE LEFT EYE. THE PATIENT IS SEEING HALOS, GLARES, FLARES AND WHAT LOOKS LIKE SPIDER WEBS AROUND LIGHT SOURCES. THESE SYMPTOMS HAVE BEEN NOTED OVER THE LAST THREE (3) MONTHS. THE PATIENT HAD A YTTRIUM-ALUMINUM GARNET (YAG) POSTERIOR CAPSULOTOMY PROCEDURE PERFORMED ON (B)(6) 2019 WHICH HE STATES DID NOT HELP HIM. PATIENT STATES HIS SYMPTOMS HAVE BECOME MORE ACUTE AND INDICATED THAT HE HAS MORE ISSUES WITH FLOATERS NOW THAN BEFORE. ON (B)(6) 2019, THE PATIENT SAW A RETINA SPECIALIST AND AN ANOTHER OPHTHALMOLOGIST ON (B)(6) 2019. THE RETINA SPECIALIST TOLD HIM THAT HE MAY NEED TO HAVE A VITRECTOMY DONE; PATIENT DID NOT KNOW THE REASON FOR THIS. THE PATIENT NOTES THAT HE DOES NOT HAVE MUCH FAITH IN THE RETINA SPECIALIST AND DOES NOT WANT TO SEE THAT DOCTOR. THE PATIENT REPORTED THAT HE SAW ANOTHER OPHTHALMOLOGIST, BUT THEY COULD NOT GET HIS LEFT EYE VISON CORRECTED AND COULD NOT GIVE HIM GLASSES TO

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9183079 ↗
• MalfunctionSep 26, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THERE WAS AN UNFOLDING ISSUE WITH THE INTRAOCULAR LENS (IOL). THE LENS WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE AND THE SURGERY WAS COMPLETED WITH ANOTHER LENS (DIFFERENT MODEL AND DIOPTER). THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9125411 ↗
• InjuryMay 21, 2019Adverse 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 LEFT EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT A HIGHER DIOPTER (20.0). THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION REVEALED NO ADDITIONAL INTERVENTION WAS REQUIRED. THE DATE THE SYMPTOMS WERE FIRST REPORTED WAS NOT AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8629868 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +16.0 DIOPTER) WAS REMOVED FROM PATIENT¿S RIGHT EYE AND THE PATIENT LEFT APHAKIC. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT VITRECTOMY WAS PERFORMED. PATIENT WAS DOING FINE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED,

  Patient problems: Vitrectomy

  MAUDE report 8490212 ↗
• InjuryJan 2, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO VISUAL ISSUES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.0. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8210972 ↗
• InjuryJul 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIC MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +16.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7666312 ↗
• InjuryJul 5, 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 COLLAPSED AFTER A ZCB00 16.0 DIOPTER INTRAOCULAR LENS WAS INSERTED INTO THE LEFT EYE (OS). THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A ZA9003 15.5 DIOPTER LENS. NO INCISION ENLARGEMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7663065 ↗
• InjuryJun 1, 2018Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING IMPLANTATION, THE INTRAOCULAR LENS (MODEL ZCB00 +16.0 DIOPTER) DID NOT UNFOLD EVENLY IN THE EYE. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED FROM THE EYE. NO SUTURES WERE USED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7560533 ↗