TECNIS IOL ZCB00 (REF ZCB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05050474531703), received between Nov 7, 2016 and Jun 26, 2026 — classified as 38 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 81 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, WAS REMOVED WITH ASSOCIATED VITREOUS MATERIAL AND REQUIRED REPLACEMENT. PATIENT MOVEMENT DURING THE PROCEDURE WAS NOTED. THE COMPLAINT DEVICE WAS DISCARDED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25641572 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO BOTH THE PATIENT¿S LEFT AND RIGHT EYE. THE DAY AFTER THE SURGERY THE PATIENT REPORTED SEEING RIDGES ON THE SIDES OF THE EYES LIKE BEVELED GLASS. THE PATIENT WAS INFORMED BY HER PHYSICIAN THAT SHE WAS SEEING THE SUTURES. THE PATIENT STATED THAT THE SYMPTOMS HAVE NOT GONE AWAY. SHE IS EXPERIENCING GLARE THAT MAGNIFIES LIGHT AND INTERFERES WITH HER VISION WHEN SHOPPING IN STORES AND GOING TO RESTAURANTS. PATIENT CAN DRIVE BUT SEES A HALF-MOON IN THE PREREFERRAL VISION ON THE OUTSIDE OF HER LEFT EYE. IT OBSTRUCTS HER VISION WHEN MAKING TURNS WHILE DRIVING. HER PHYSICIAN SAID IT WAS TOO RISKY FOR HER TO DRIVE AND THE PROCEDURE OCCURRED LONG AGO. ADDITIONALLY, SHE HAS TO MUCH CAR TISSUE FOR AN IOL EXCHANGE AND SHE WILL HAVE TO GET USED TO THIS. THE PHYSICIAN ALSO ADVISED HER TO SEE A DIFFERENT DOCTOR AT THE SAME PRACTICE BUT SHE DID NOT BECAUSE SHE DOES NOT HAVE CONFIDENCE IN THE RECOMMENDED DOCTOR. HOWEVER, THE PATIENT TRIED TO GET A SECOND OPINION AT A DIFFERENT FACILITY, (B)(6). REPORTEDLY, SHE WAS NOT ACCEPTED. THE PATIENT HAD A BRAIN ANEURISM SEVERAL YEARS AGO THAT DID NOT IMPACT HER VISION. T

  Patient problems: Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 25627335 ↗
• InjuryJun 1, 2026Break; Difficult to Insert

  IT WAS REPORTED THAT A FULLY IMPLANTED SINGLE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE IN THE SAME PROCEDURE. THE REASON FOR THE REMOVAL WAS UNSPECIFIED. IT WAS ALSO MENTIONED THAT VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. THE INCISION WAS ALSO ENLARGED. THERE WAS ALSO A REPORTED SURGICAL DELAY IN PROCEDURE. PATIENT STATUS WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352711 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE LENS ITSELF WAS DESCRIBED AS BEING FINE, BUT THE PATIENT EXPERIENCED DIFFICULTY SEEING, WHICH WAS BELIEVED NOT TO BE CAUSED BY THE LENS. THE PATIENT WAS SUBSEQUENTLY PROVIDED WITH A CHAMBER IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25236926 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL IOL (MODEL ZCB00) WAS FOUND TO HAVE A BROKEN HAPTIC. THE DEVICE CONTACTED THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913480 ↗
• InjuryApr 5, 2026Break

  DURING APPLICATION INTO THE PATIENT'S EYE, A DEFECT ON THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS NOTED. THE IOL WHICH WAS PARTIALLY INSERTED WAS REMOVED AND THE SAME PROCEDURE WAS COMPLETED USING A BACK-UP ZCB00 19.5 IOL, WHICH WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). AN UNPLANNED VITRECTOMY WAS PERFORMED HOWEVER, NO INCISION ENLARGEMENT OR SUTURES WERE NEEDED. PATIENT PROGNOSIS POST PROCEDURE WAS REPORTED AS GOOD. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787035 ↗
• MalfunctionAug 29, 2025Difficult to Insert; Difficult to Insert

  THE ZCB00 IOL MODEL INTRAOCULAR LENS (IOL) WAS OPENED IN THE FIELD BUT WAS NOT IMPLANTED AS THE LENS WOULD NOT SIT CORRECTLY IN THE PATIENT'S EYE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT 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 22927048 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED BECAUSE IT WAS DEFECTIVE. THE DETAILS ABOUT THE DEFECT WERE NOT PROVIDED. A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689669 ↗
• MalfunctionMay 29, 2025Scratched Material; Ejection Problem; Scratched Material; Ejection Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BECAME TRAPPED IN THE INCISION DURING THE INJECTION, NECESSITATING ITS REMOVAL WITH FORCEPS. UPON REMOVAL, THE IOL WAS LEFT MARKED, NECESSITATING A BACK UP LENS TO COMPLETE THE SURGERY. THROUGH FOLLOW-UP, WE LEARNED IT WAS CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY ADVERSE EVENTS AS A RESULT OF THE INCIDENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109144 ↗
• MalfunctionMar 14, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CRACKED AFTER BEING DELIVERED INTO THE EYE. THE DOCTOR SUCCESSFULLY REMOVED THE LENS WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION REVEALED THAT THE ZCB00 WAS NOTED TO HAVE 2 HORIZONTAL CRACKS IN THE PERIPHERAL OPTIC AREA AFTER IT WAS INSERTED INTO THE EYE. THE IOL WAS SOMEWHAT DIFFICULT TO ADVANCE FORWARD IN THE CARTRIDGE WITH THE INSERTER, AND THERE WAS INITIAL RESISTANCE REGARDLESS OF THE AMOUNT OF VISCOELASTIC USED. IT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER J&J LENS. THE PATIENT APPEARED COMFORTABLE DURING AND IMMEDIATELY POST-PROCEDURE. FURTHER INFORMATION SUGGEST THE PATIENT IS MAKING SLOW BUT APPROPRIATE PROGRESS WITH VISUAL ACUITY WITH NO NEGATIVE OUTCOME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21611364 ↗
• MalfunctionNov 12, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668545 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT SEVERAL MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE DEFECTIVE. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT IOL MODEL ZCB00/SERIAL NUMBER (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER 5 SUSPECT IOLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032008 ↗
• MalfunctionOct 30, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS IMPLANTED INSIDE THE PATIENT'S OPERATIVE EYE, AND THE SURGEON NOTICED A SCRATCH ON THE LENS. THE SURGEON REMOVED THE LENS DURING THE SAME SURGERY WITH COULTERS AND GRASPERS AND USED A BACK UP LENS. ONLY HALF OF THE LENS WAS RETRIEVED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED OUTSIDE STANDARD OF CARE. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT WAS DISCHARGED AS ANY OTHER PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036081 ↗
• MalfunctionJul 24, 2023Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE, BUT THEN REMOVED DUE TO THERE BEING DEPOSITS ON THE LENS. IT WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379603 ↗
• InjuryApr 21, 2023Break; Break

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE IOL FELL BACK INTO THE PATIENT'S EYE. THE IOL WAS BROKEN INTO TWO (2) PIECES. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 16792252 ↗
• MalfunctionApr 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS WASTED, INSERTED AND REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704597 ↗
• MalfunctionDec 9, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT A LINE WAS FOUND ON THE IOL AFTER IT WAS FULLY IMPLANTED INTO THE PATIENT'S EYE. IOL WAS LEFT IN THE PATIENT'S EYE AS THERE WAS NO IMPACT ON THE PATIENT'S VISION. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954098 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED HAVING A PATIENT ISSUE. THEY INDICATED SACK TORN WHILE INSERTING AN INTRAOCULAR LENS (IOL) INTO A PATIENT'S LEFT EYE. THE IOL WAS CUT OUT AND REPLACED. THE INCISION HAD TO BE ENLARGED. IT IS UNCLEAR WHETHER THE IOL CAUSED THE CAPSULE TEAR. THE REPLACEMENT LENS IS A DIFFERENT JOHNSON & JOHNSON IOL MODEL ZA9003, +19.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14739186 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT (PT) THAT IT IS BELIEVED THAT THE DOCTOR IMPLANTED THE WRONG INTRAOCULAR LENSES (IOLS) IN BOTH EYES BECAUSE GLASSES ARE NOW REQUIRED TO DRIVE, READ, AND SEE. THE PT HAS A PRE-EXISTING CONDITION WHERE THE EYEBALLS ARE ¿TILTED.¿ THE DOCTOR HAD THE PT FOLLOW-UP MULTIPLE TIMES, WITH NO MENTION OF AN ISSUE, ONLY THAT THE PT¿S ¿EYES ARE VERY UNIQUE.¿ IN (B)(6) 2022, THE PT WAS REFERRED TO A GLAUCOMA SPECIALIST AND WAS TOLD THAT THE EYES ARE VERY DRY, NOT PRODUCING TEARS, AND THAT GLASSES ARE NEEDED AS THE PT CANNOT SEE WELL. THE PT IS USING PRESERVATIVE FREE LUBRICATING DROPS 4-5 TIMES A DAY. THE PT WAS TOLD THAT IT IS POSSIBLE THAT THE VISION IS BEING IMPAIRED, AND THE PT IS LOSING THE SIGHT FROM THE CORNERS. THE PT CAN STILL PERFORM DAILY ACTIVITIES, BUT MUST BE MORE CAREFUL, AS CERTAIN TIMES THE PT CAN¿T SEE AT ALL, CAUSING BALANCE TO BE OFF. THE DOCTOR PERFORMED A LASER TREATMENT WHICH ¿LIFTS THE LENS UP AND TAKES OUT ALL THE JUNK.¿ ANOTHER DOCTOR ADVISED THE PT THAT THE LASER TREATMENT SHOULD NOT HAVE BEEN PERFORMED BECAUSE NOW THE EYE PRESSURE IS AFFECTED, AND IT IS UNKNOWN IF IT IS DUE TO THE LASER. THE PT HAS A HISTORY OF LASIK SURGERY 20 YEARS AGO.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Glaucoma; Headache; Insufficient Information; Visual Impairment

  MAUDE report 14722078 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BENT/ BROKEN HAPTIC AND THE LENS HAD A KNICK IN IT. THE ISSUE WAS NOTICED AFTER INSERTION. THE LENS HAD TO BE CUT OUT, REMOVED FROM PATIENT'S RIGHT EYE AND REPLACED WITH A COMPETITOR LENS DURING THE SAME PROCEDURE. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13362500 ↗
• MalfunctionDec 14, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD WHEN ATTEMPTS WERE MADE TO SLIDE IT INTO THE PATIENT¿S RIGHT EYE. THE CARTRIDGE WAS PLACED HALFWAY IN AND HALFWAY OUT OF THE EYE. THE DOCTOR THINKS THE CARTRIDGE WAS NOT IN THE EYE ALL THE WAY AND THAT IS WHY THE LENS DID NOT GO IN ALL THE WAY. THE DOCTOR BELIEVES THE IOL DID NOT UNFOLD DUE TO THE CARTRIDGE NOT BEING CORRECTLY IN THE EYE. THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. IT WAS LEARNED THAT BECAUSE THE LENS WAS NOT FULLY IN THE EYE (HALF-WAY IN AND HALF-WAY OUT OF THE EYE), THE LENS DID NOT UNFOLD AT ALL. THERE WAS NO ISSUE WITH THE CARTRIDGE. THE DOCTOR USED A MCPHERSON TO TAKE THE LENS FROM THE EYE. THERE WERE NO ATTEMPTS TO PUSH THE IOL INTO THE EYE. THE DOCTOR IMMEDIATELY IMPLANTED A NEW IOL (SAME MODEL, SAME DIOPTER) USING A NEW CARTRIDGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006357 ↗
• InjurySep 16, 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12485717 ↗
• MalfunctionAug 9, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT POST CAPSULARY TEAR WAS NOTICED AFTER INSERTION OF A ZCB00 MODEL INTRAOCULAR LENS(IOL) IN THE PATIENT'S RIGHT EYE. ALSO IT WAS MENTIONED THAT LENS WENT BLOOP ALL OF A SUDDEN. ADDITIONAL DETAILS RECEIVED CONFIRMS THAT THE LENS WAS ONLY PARTIALLY INSERTED AND AS THE LENS WAS BEING INSERTED, SURGEON IDENTIFIED A MANUFACTURER DEFECT, SAID THAT THE LENS WAS DEFORMED AND THAT THE POST CAPSULARY TEAR WAS UNRELATED TO THIS INCIDENT AND WAS DUE TO PATIENT ANATOMY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. NO SUTURES OR ANY MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT WAS DOING GOOD AND STABLE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12298506 ↗
• MalfunctionJul 14, 2021Break; Use of Device Problem; Material Split, Cut or Torn; Break; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A LOADING ISSUE AND UPON INSERTION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT''S LEFT EYE, THE SURGEON REALIZED THE IOL WAS TORN. THERE WAS NO INCISION ENLARGEMENT, AND THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITY. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170796 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). DURING FOLLOW-UP APPOINTMENT PATIENT WAS INFORMED THAT IT WAS CLOUDY IN THERE AND THE DOCTOR WANTS TO DO A LASER (YTTRIUM ALUMINUM GARNET - YAG) PROCEDURE TO PRODUCE A HOLE IN HER LENS TO CLEAR UP HER VISION. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING REPORTED CLOUDY AS THE MEMBRANE (CORNEAL OPACITY) HAD TO BE ZAPPED; THERE WAS NO MENTION OF MEMBRANE INFLAMMATION. YAG PROCEDURE WAS PERFORMED (B)(6) 2021 AND NO MEDICATION WAS GIVEN TO THE BUT THE PATIENT WAS INSTRUCTED NOT TO RUB HER EYES. NEXT FOLLOW-UP APPOINTMENT IS SCHEDULED FOR (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 12140806 ↗