TECNIS IOL ZCB00 (REF ZCB0000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 05050474531734), received between Sep 1, 2016 and Sep 18, 2026 — classified as 56 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that the haptic of the non-preloaded monofocal intraocular lens (IOL) was found to be broken while preparing the lens for insertion into the eye. There was patient contact with the device. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820637 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, INTO THE PATIENT¿S RIGHT EYE, POSTERIOR CAPSULE OPACIFICATION WAS NOTED DURING A POSTOPERATIVE EXAMINATION. THE CONDITION WAS SUCCESSFULLY TREATED WITH YAG LASER CAPSULOTOMY, AND THE PATIENT FULLY RECOVERED WITH NO IMPACT ON ACTIVITIES OF DAILY LIVING. BEST CORRECTED VISUAL ACUITY (BCVA) IMPROVED FROM 20/25 PREOPERATIVELY TO 20/20 POSTOPERATIVELY. THE DIRECTIONS FOR USE WERE FOLLOWED AND THE COMPLAINT DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25671126 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POSTERIOR CAPSULE OPACIFICATION (PCO) FOLLOWING IMPLANTATION OF A SINGLE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE CONDITION WAS IDENTIFIED DURING A POSTOPERATIVE SITE EXAMINATION AND WAS SUBSEQUENTLY RESOLVED WITH A YAG LASER CAPSULOTOMY PROCEDURE. THE PREOPERATIVE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/30, WHICH IMPROVED POSTOPERATIVELY TO 20/20. THE PATIENT WAS FULLY RECOVERED AND THE IOL REMAINS IMPLANTED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED, AND THE DIRECTIONS FOR USE WAS FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25671090 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A SINGLE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE CAPSULAR BAG BROKE. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24981760 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED AFTER IT WAS FULLY INSERTED INTO PATIENT'S EYE. LENS WAS REMOVED IN SAME PROCEDURE. THE PATIENT ACHIEVED A POST-OPERATIVE BEST CORRECTED VISUAL ACUITY OF 6/20. THERE WERE NO OCCURRENCES OF UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS. THE DIRECTIONS FOR USE WERE FOLLOWED AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958550 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT EYE WAS REPORTEDLY EXCHANGED FOR AN UNSPECIFIED REASON FOLLOWING ITS INITIAL IMPLANTATION. THE REPLACEMENT IOL WAS A JOHNSON & JOHNSON MODEL OF THE SAME TYPE, BUT WITH A DIFFERENT DIOPTER POWER (ZCB00, 23.0). NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 24508451 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A MONOFOCAL INTRAOCULAR LENS (IOL) IN THE LEFT EYE ON (B)(6) 2025. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A COMPLETE ABSENCE OF FOCUS FOR BOTH NEAR AND DISTANCE VISION ALONG WITH CONSTANT DISTORTED VISION AND INTENSE LIGHT HALOS IN LOW-LIGHT ENVIRONMENTS. THE CONDITION SEVERELY COMPROMISED THEIR ABILITY TO DRIVE AND WORK AT NIGHT. THESE ISSUES WERE REPORTED TO THE SURGEON FROM THE FIRST POSTOPERATIVE DAY, AND TREATMENT WITH PILOCARPINE 0.5% WAS INITIATED TO INDUCE MIOSIS; HOWEVER, THIS PROVIDED ONLY TEMPORARY RELIEF AND CAUSED CONJUNCTIVAL HYPEREMIA, WITH HALOS RETURNING AFTER THE EFFECT WORE OFF. IT WAS NOTED THAT THE PHYSICIAN ADVISED AGAINST REPLACING THE IOL DUE TO SURGICAL RISKS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Hyperemia

  MAUDE report 24310488 ↗
• MalfunctionFeb 9, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, WAS OPENED BUT NOT USED AFTER THE SURGEON OBSERVED THAT THE LENS APPEARED ABNORMAL OR POSSIBLY STUCK. NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293974 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT EYE DURING A CLINICAL STUDY, IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT AND LEFT EYE. DURING A POST-OPERATIVE EXAMINATION FOR BOTH EYES POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED. REPORTEDLY THE DIRECTIONS FOR USE WERE FOLLOWED. THE SYMPTOMS WERE NOT DEBILITATING AND THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENTS BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVELY WAS 40 AND BSCVA POST OPERATIVE WAS REPORTED AS 20. ON (B)(6) 2024, DURING A YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT) EVALUATION THE PCO IN THE RIGHT EYE WAS RESOLVED BY THE YAG LASER CAPSULOTOMY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23764702 ↗
• MalfunctionJul 31, 2025Break; Break

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. EXTENT OF PATIENT CONTACT AND PATIENT PROGNOSIS POST-PROCEDURE ARE BOTH UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682739 ↗
• InjuryApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF LENS DISPLACEMENT, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, LI61SE. THERE WAS NO MEDICAL INTERVENTIONS, NO PATIENT INJURY, AND NO SURGICAL INTERVENTIONS DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21861818 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED WHICH WAS NOTICED ON INSERTION OF THE IOL INTO A PATIENT'S RIGHT EYE. THE FULLY INSERTED LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME DIOPTER. THE INCISION WAS ENLARGED, BUT NO DELAY IN PROCEDURE REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE NECESSARY. IT WAS NOTED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE. THE ISSUE DID NOT AFFECT PATIENT'S DAILY ACTIVITIES. THE PATIENT FULLY RECOVERED FROM THE PROCEDURE AND NO COMPLICATIONS WERE REPORTED. THE PRODUCT WAS DISCARDED AFTER USE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 21329398 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT UNKNOWN COMPLAINT. PROCEDURE WAS COMPLETED WITH A NON-J&J LENS. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 21144143 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT WHEN DOCTOR DID THE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) INSERTION, THERE WAS RESISTANCE, WHEN PUSHED INTO THE EYE. IOL WAS FULLY INSERTED INTO PATIENT'S EYE. THERE WAS A DEFECT AT THE HAPTIC OPTIC JUNCTION, THEREFORE DOCTOR REMOVED THE IOL DURING THE SAME PROCEDURE AND REPLACED IT WITH BACKUP IOL. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441418 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE PROCEDURE THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS CHANGED FOR A SULCUS LENS DUE TO PATIENT WITH MODERATE ZONULAR DEHISCENCE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18361567 ↗
• MalfunctionOct 31, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING INSERTION OF IOL INTO THE PATIENT EYE, A PLASTIC-LIKE FOREIGN MATERIAL WAS SEEN ENTERING INTO THE EYE. THE IOL WAS FULLY INSERTED AND FOREIGN MATERIAL WAS REMOVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044512 ↗
• MalfunctionOct 28, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. THERE WAS PATIENT CONTACT. IT WAS REPLACED WITH ANOTHER UNKNOWN J&J MODEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026781 ↗
• MalfunctionJul 12, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. STATUS OF PATIENT CONTACT WITH THE PRODUCT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17308813 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) BROKE WHEN TRYING TO IMPLANT. IT CANNOT BE PLACED IN THE PATIENT'S EYE. IT WAS LEARNED THROUGH COMPLAINT FORM INFORMATION THAT DURING IMPLANTATION, IOL WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE, THERE WAS A 20 MIN. DELAY IN PROCEDURE, AND SUTURES PERFORMED. IT WAS LEARNED THAT AMOUNT OF SUTURE USED WAS FOR REGULAR STANDARD OF CARE. A NON-JOHNSON AND JOHNSON LENS WAS USED AS BACK-UP LENS. THERE WAS SIGNIFICANT CORNEAL EDEMA. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015179 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT¿S OPERATIVE EYE, THE BAG BROKE. THE LENS WAS TAKEN OUT AND A DIFFERENT IOL, A 3-PIECE LENS WAS IMPLANTED (SERIAL NUMBER OF REPLACEMENT LENS WAS NOT A VALID JOHNSON & JOHNSON LENS NUMBER). THE PATIENT OUTCOME WAS NOT PROVIDED, BUT IT WAS INDICATED THAT THERE WAS NO INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16397313 ↗
• MalfunctionSep 8, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15387017 ↗
• InjuryJul 5, 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 PATIENT'S OPERATIVE EYE. THE REASON FOR EXPLANT WAS NOT PROVIDED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS REPORTED. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14921486 ↗
• MalfunctionJan 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) RIPPED OFF DURING IMPLANTATION INTO PATIENT'S LEFT EYE. THE LENS WAS CUT OUT AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261597 ↗
• MalfunctionJan 6, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT AND HAPTIC BROKE OFF. IT IS UNKNOWN IF THE LENS HAD BEEN INSERTED OR NOT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13184094 ↗
• InjuryNov 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO PATIENT'S LEFT EYE AND WAS REMOVED BECAUSE THE OPTIC WAS TORN. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND CUSTOMER BELIEVES THAT SUTURES MIGHT HAVE BEEN DONE. PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821237 ↗