TECNIS IOL ZCB00 (REF ZCB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 05050474531697), received between Sep 2, 2016 and Aug 27, 2026 — classified as 31 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  It was reported that during cataract surgery, a non-preloaded monofocal intraocular lens (IOL) was implanted in the patient's eye. Following insertion of the IOL, the optic was observed to be cracked. There was patient contact with the device. The affected IOL was removed and replaced with an identical backup lens, and the procedure was completed successfully. The crack in the optic was first noted after lens insertion. The reporter indicated that the damage was not due to use error. It is unknown whether the tip of the cartridge was damaged. No patient injury, including capsule tear, was reported. No unplanned medical or surgical interventions, such as vitrectomy, incision enlargement, or sutures, were required. The current patient outcome is unknown. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476464 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 30 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 LEFT EYE WAS RESOLVED BY THE YAG LASER CAPSULOTOMY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THIS REPORT CAPTURES THE LEFT EYE. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0003094.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23764703 ↗
• MalfunctionNov 11, 2025Wrong Label; Wrong Label

  THE ZCB0000190 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). HOWEVER, A PACKAGING OR LABELING ISSUE RESULTED IN THE USE OF AN INCORRECT LENS; THE INTENDED IOL WAS A ZCB00 29.0. THERE IS NO INDICATION THE ZCB00 HAS BEEN REMOVED/EXPLANTED FROM THE PATIENT'S OD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527495 ↗
• MalfunctionNov 7, 2025Scratched Material; Scratched Material

  IT WAS REPORTED BY THE PATIENT THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) THAT IS CURRENTLY IMPLANTED IN THE RIGHT EYE IS SCRATCHED. THE PATIENT ALSO COMPLAINED OF BLURRY VISION. THE PATIENT WANTED TO KNOW IF THE LENS COULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23502635 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT EXPERIENCED INTOLERABLE DYSPHOTOPSIA. THE SYMPTOMS PERSISTED DESPITE ADJUSTMENTS, AND THE PATIENT REPORTED FEELING UNSAFE AND UNABLE TO DRIVE. AN IOL EXCHANGE WAS PERFORMED IN A SECONDARY SURGICAL PROCEDURE, REPLACING THE IMPLANT WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO INDICATION THAT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME REMAINS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23477783 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED TORIC IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A DIFFERENT MODEL OF JOHNSON & JOHNSON IOL. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22523997 ↗
• InjuryJul 16, 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). POST-OPERATIVELY, THE PATIENT CHANGED HER MIND DUE TO REFRACTIVE TARGET, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; THE INFORMATION REGARDING THE REPLACEMENT IOL IS UNAVAILABLE. PATIENT SYMPTOMS PERSISTED FOR FOURTEEN (14) DAYS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IN UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22516871 ↗
• MalfunctionApr 18, 2025Material Opacification; Material Opacification

  INITIALLY REPORTED THAT SOME BLACK DOTS HAD BEEN FOUND ON THE SURFACE OF THE OPTIC OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) RIGHT AFTER IMPLANTATION AND THE SURGEON DECIDED NOT TO EXCHANGE IOL ON THE DAY BUT IOL EXCHANGE MAY HAPPEN DEPENDING ON THE PATIENT'S DISCOMFORT AND POST-OP RESULT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 4/24/2025 STATED THAT THE SURGEON CONFIRMED THAT THE "BLACK DOTS FOUND ON THE SURFACE OF THE OPTIC¿ ARE NOT FOREIGN MATERIAL BECAUSE SHE TRIED TO REMOVE IT DURING THE SURGERY BUT NOTHING WAS IMPROVED. SO, SHE THOUGHT THIS ISSUE IS ASSOCIATED WITH LENS OPTIC ITSELF. THESE BLACK DOTS DID NOT LEAD TO VISUAL IMPAIRMENT AND PATIENT DOES NOT FEEL ANY DISCOMFORT AFTER SURGERY. DOCTOR DECIDED NOT TO EXCHANGE INTRAOCULAR LENS (IOL) SINCE THERE WAS NO VISUAL IMPAIRMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869145 ↗
• MalfunctionFeb 11, 2025Failure to Fold; Use of Device Problem; Scratched Material; Ejection Problem; Failure to Fold; Use of Device Problem; Scratched Material; Ejection Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS NOT FOLDED PROPERLY AND WAS SCRATCHED; LENS WAS NOT FULLY INSERTED. IT UNKNOWN IF THE PROCEDURE WAS COMPLETED USING ANOTHER LENS HOWEVER, THERE WAS NO MEDICAL INTERVENTION AND NO PATIENT INJURY. PATIENT PROGNOSIS POST-PROCEDURE REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360920 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED AND IT WAS NOTICED AFTER IMPLANTATION THERE WAS A DEFECT IN THE CENTER OF THE OPTIC OF THE LENS. IT WAS STATED THAT THE DEFECT WAS NOT DUE TO THE PUSHROD OVERRIDING THE OPTIC. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358653 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE OF CAPSULE TEAR WITH A MONOFOCAL INTRAOCULAR LENS (IOL) WHICH INDICATED TO BE UNCLEAR PER SURGEON HOW THE CAPSULE TEAR OCCURRED. IT WAS NOTED THAT THERE WAS NO PRODUCT QUALITY ISSUE, NO PATIENT ANATOMY ISSUE. THERE WAS PATIENT CONTACT WITH THE SUSPECT PRODUCT, EYE AFFECTED WAS THE LEFT EYE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS, THOUGH UNKNOWN MODEL AND SERIAL NUMBER. ALSO UNKNOWN IF THERE WAS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES PERFORMED. THE DEVICE CANNOT BE RETURNED AS IT HAS BEEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20626762 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHACO WAS DONE UNTIL THE MONOFOCAL NON PRELOADED INTRAOCULAR LENS (IOL) INSERTION. UPON VISCO REMOVAL, IT WAS NOTED THAT THERE WAS A ZONULAR DIALYSIS 180 DEGREE FROM 7 O'CLOCK. IOL WAS REMOVED DURING SAME PROCEDURE. VITRECTOMY WAS PERFORMED AND SUTURES WERE REQUIRED. MEDICATIONS WERE PRESCRIBED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 20287415 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT AN ANTERIOR VITRECTOMY WAS PERFORMED BY THE SURGEON AND A BACKUP LENS WAS UTILIZED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184190 ↗
• MalfunctionJan 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE, THE SURGEON FOUND YELLOW MATERIAL IN THE EYE. BOTH THE IOL AND FOREIGN MATERIAL WAS REMOVED AND A NEW IOL WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477759 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNKNOWN REGAIN. OTHER PATIENT INJURIES, INTERVENTIONS AND OUTCOMES WAS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 17873853 ↗
• MalfunctionAug 8, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN REMOVED DUE TO A GASH; A SCRATCH WAS NOTICED ON THE OPTIC. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477529 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) HAPTIC WAS DAMAGED AND THERE WAS PATIENT CONTACT. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE SUSPECT LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114436 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS WERE INDICATED. IT WAS INDICATED THE PRODUCT WILL NOT BE RETURNED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 16260470 ↗
• MalfunctionMay 13, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED DUE TO A BENT HAPTIC. THE SAME PROCEDURE COMPLETED SUCCESSFULLY USING ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT OUTCOME WAS REPORTED AS GOING GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401743 ↗
• MalfunctionOct 22, 2021Break; Break

  IT WAS REPORTED THAT A SMALL CRACK WAS OBSERVED ON THE INTRAOCULAR LENS (IOL) AFTER BEING PLACED A COUPLE OF YEARS EARLIER. REPORTEDLY, THE IMPLANT PROCEDURE WAS UNCOMPLICATED. SURGEON BRIEF DESCRIPTION OF THE EVENT REVEALED THAT A CRACK WAS IDENTIFIED BELOW THE VISUAL AXIS UPON A ROUTINE FOLLOW-UP VISIT. NO YTTRIUM ALUMINUM GARNET (YAG) WAS PERFORMED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686253 ↗
• InjuryOct 18, 2021Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO PATIENT'S LEFT EYE WITHOUT ANY PROBLEM. HOWEVER, POST-OPERATIVE EXAMINATION REVEALED A MIGRATED HAPTIC. THE LENS WAS EXPLANTED AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Macular Edema; Red Eye(s); Visual Impairment

  MAUDE report 12652638 ↗
• MalfunctionSep 7, 2021Break; Failure to Fold; Use of Device Problem; Break; Failure to Fold; Use of Device Problem

  IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) WAS NOT INSERTED DUE TO LOADING/FOLDING ISSUE AND THE HAPTIC WAS BENT WRONG DURING HANDLING. THERE WAS PATIENT CONTACT AND THE PATIENT HAS RECOVERED. THE LENS WAS DISCARDED AT THE CUSTOMER'S FACILITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436993 ↗
• InjuryMay 10, 2021Adverse 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 DUE TO THE PATIENT EXPERIENCING DECREASED AND BLURRY VISION. VISUAL ACUITY PRE-OP: 20/30 -2 UNCORRECTED. VISUAL ACUITY POST-OP: 20/25 UNCORRECTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS VERY HAPPY WITH THE OUTCOME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11803104 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE LENS WAS DAMAGED, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER DESPITE SEVERAL FOLLOW UPS. IT IS UNKNOWN IF THE LENS IS AVAILABLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345830 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS(IOL) WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325469 ↗