TECNIS IOL ZCB00 (REF ZCB0000200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 05050474531710), received between Aug 25, 2016 and May 13, 2026 — classified as 43 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Physical Resistance/Sticking

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). DURING A SURGICAL PROCEDURE PERFORMED ON A PATIENT THE TREATING DOCTOR REPORTED THAT AT THE MOMENT OF IMPLANTING THE INTRAOCULAR LENS INTO THE ANTERIOR CHAMBER, FOLLOWING THE INJECTION OF THE DEVICE THROUGH THE CARTRIDGE, IT WAS OBSERVED THAT ONE OF THE HAPTICS REMAINED ADHERED TO THE OPTICAL BODY OF THE LENS. DESPITE PERFORMING INTRAOPERATIVE MANEUVERS TO FACILITATE THE DEPLOYMENT OF THE IOL, IT WAS NOT POSSIBLE TO RELEASE THE HAPTIC OR CORRECTLY IMPLANT THE DEVICE, THEREBY RENDERING ITS PROPER POSITIONING IMPOSSIBLE. REPORTEDLY, THE PACKAGING WAS CHECKED AND SHOWED NO SIGNS OF DAMAGE. THE EXPIRATION DATE WAS CURRENT. NO FURTHER INFORMATION WAS PROVIDED. NOTE. THE CUSTOMER INADVERTENTLY SUBMITTED TWO DIFFERENT SERIAL NUMBERS FOR THE SAME EVENT. THE SERIAL NUMBER LISTED IN THE EMAIL SUBJECT LINE DOES NOT MATCH THE SERIAL NUMBER FOUND IN THE ATTACHED DOCUMENTATION. BOTH SERIAL NUMBERS WERE REPORTED AS FOLLOWS: (B)(6) MANUFACTURER REPORT NUMBER (B)(6) MANUFACTURER REPORT NUMBER 3012236936-2026-0001323.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156944 ↗
• MalfunctionFeb 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED BY THE SURGEON THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE EYE BECAUSE IT HAD A SLIT IN IT. NO PATIENT HARM OCCURRED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE LENS IN THE RIGHT EYE WAS FULLY DELIVERED AND WAS SUBSEQUENTLY REMOVED DUE TO A TORN OPTIC. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. THE IOL WAS NOT DAMAGED BY THE PLUNGER. NO UNPLANNED VITRECTOMY, SUTURES, OR CAPSULAR TEAR OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397189 ↗
• MalfunctionFeb 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING INSERTION OF A SINGLE-PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE HAPTIC WAS NOTED TO HAVE FALLEN OFF AFTER IMPLANTATION. THE ORIGINAL IOL WAS REMOVED AND REPLACED WITH A BACKUP IOL OF THE SAME MODEL AND DIOPTER WITHOUT COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT. NO UNPLANNED SURGICAL INTERVENTIONS OR ADDITIONAL MEDICATIONS WERE REQUIRED. ACCOUNT STATED THAT THE CARTRIDGE DID NOT TOUCH THE EYE, THAT DIRECTIONS FOR USE WERE FOLLOWED, AND THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274072 ↗
• 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 SUBJECT 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 20 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 23712623 ↗
• MalfunctionNov 27, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DOCTOR NOTICED AN INTRAOCULAR LENS (IOL) FRAGMENT IN THE PATIENT'S EYE AFTER LENS WAS IMPLANTED. DOCTOR PROCEEDED TO REMOVE THE FRAGMENT FROM PATIENT'S EYE DURING THE SAME PROCEDURE AND FINISHED THE OPERATION AS PER NORMAL. IOL REMAINS IMPLANTED IN PATIENT'S EYE. THERE WAS NO ANY PATIENT INJURY. NO ANY OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE. THE CARTRIDGE WAS DISPOSED AFTER THE OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800813 ↗
• MalfunctionNov 5, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE NON-PRELOADED INTRAOCULAR LENS (IOL) AND IT WAS WASTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614760 ↗
• MalfunctionOct 8, 2024Scratched Material; Ejection Problem; Scratched Material; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD THE CARTRIDGE TIP TOUCH THE PATIENT'S RIGHT EYE. IT WAS NOTED THAT THE CUSTOMER WHEN TRYING TO PUSH THE IOL INTO THE PATIENT'S EYE, THE CARTRIDGE WOULD COME OUT OF WOUND AND THE LENS WOULD COME OUT OF THE CARTRIDGE AND NOT INTO THE PATIENT'S EYE. THE LENS WAS NOT STUCK IN CARTRIDGE. THEY LOADED THE LENS 3X BUT DID NOT USE. BECAUSE THEY WERE AFRAID THAT LENS MAY HAVE BEEN SCRATCHED. IT WAS STATED THAT THERE WAS INCISION ENLARGEMENT. PATIENT IS FINE POST-OP, NO OTHER PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20403953 ↗
• 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 20033006 ↗
• MalfunctionJul 28, 2023Labelling, Instructions for Use or Training Problem; Delivered as Unsterile Product; Component Missing; Labelling, Instructions for Use or Training Problem; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BOX WAS RECEIVED SEALED, WITH THE FIRST PLASTIC LAYER (OUTER MOST) SEALED. UPON OPENING, THE INNER PLASTIC LAYER THAT COVERS THE LENS WAS NOT SEALED. THERE WAS NO LENS INSIDE THE LENS HOLDER, AND NO LENS STICKER AND LENS CODE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419012 ↗
• MalfunctionJul 24, 2023Device Difficult to Setup or Prepare; Ejection Problem; Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED THAT DOCTOR FOUND THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS STUCK AND COULD NOT SMOOTHLY ENTER THE ANTERIOR CHAMBER OF THE EYE. THE IOL HAPTIC WAS PULLED OUT WITH FORCEPS AND INJECTED INTO THE EYE. THE OPERATION WENT SMOOTHLY. ON THE FIRST DAY AFTER THE OPERATION, THE PATIENT'S VISUAL ACUITY WAS 0.8, WITHOUT OCULAR DISCOMFORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385554 ↗
• MalfunctionMay 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAS ONE HAPTIC BROKE OFF INTO THE INSERTER. THE IOL WAS PLACED IN THE CAPSULAR BAG OF PATIENT'S RIGHT EYE WITH ONE HAPTIC. IOL WAS CUT OUT AND REPLACED WITH A NEW IOL, SAME MODEL AND DIOPTER POWER SIZE. PATIENT DOING WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916533 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT THE ZCB00 INTRAOCULAR LENS WAS DAMAGED WHILE IMPLANTING. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687012 ↗
• InjuryFeb 15, 2023Adverse 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 RIGHT EYE DUE TO UNSPECIFIED DISORDER OF REFRACTION. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAM. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THERE WERE NO FURTHER ISSUES SUCH AS INCISION ENLARGEMENT, SUTURES OR VITRECTOMY. NO MEDICATION WAS PRESCRIBED. THE REPLACEMENT LENS IS ALSO A JOHNSON AND JOHNSON IOL MODEL ZA9003 +21.0 DIOPTER. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16383640 ↗
• InjuryFeb 2, 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, WASTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16287253 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE YEAR AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE PATIENT IS EXPERIENCING SOME VISUAL ISSUE RELATED TO THE LIGHTS. THROUGH FOLLOW UP WE LEARNED THAT THE PATIENT IS HAVING ISSUES LOOKING AT LIGHTS BECAUSE THEY APPEAR BLURRED WITH RAYS OF LIGHT RADIATING FROM THE CENTER OF THE LIGHT SOURCE. THE IOL WAS NOT EXPLANTED AND THE PATIENT CONFIRMED HE CANNOT DRIVE SAFELY BECAUSE OF THIS ISSUE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Flashers

  MAUDE report 16162249 ↗
• MalfunctionSep 14, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, REMOVED, AND REPLACED IN THE SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC. NO VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WAS REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. PATIENT HAS RECOVERED. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422933 ↗
• MalfunctionJun 21, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, IT WAS REMOVED IN THE SAME PROCEDURE AS THE LENS HAD A STAR SHAPED CRACK IN THE CENTER. ANOTHER LENS OF SAME MODEL WAS USED AS THE REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751111 ↗
• 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; Insufficient Information; Red Eye(s); Visual Impairment

  MAUDE report 14722185 ↗
• MalfunctionApr 7, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND WAS REMOVED FROM THE PATIENT'S LEFT EYE DURING THE INITIAL PROCEDURE. ANOTHER LENS OF DIFFERENT MODEL WITH SAME DIOPTER POWER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048440 ↗
• InjuryMar 22, 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 LEFT (OS) EYE IN THE SECONDARY PROCEDURE DUE TO REFRACTIVE SURPRISE. NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING REPLACEMENT. REPORTEDLY, PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 13854313 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ONE-PIECE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, THE LENS WAS REMOVED DURING THE SAME PROCEDURE DUE TO A CAPSULAR BREAK. ANOTHER J&J LENS, ZA9003 (DIFFERENT MODEL, LOWER DIOPTER) WAS ATTEMPTED TO BE USED AS THE REPLACEMENT, HOWEVER, THE IOL WAS ALSO REMOVED AS A VITRECTOMY WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER J&J SECOND THREE-PIECE LENS. THE PATIENT WAS DOING GOOD POST-OPERATION. THE ORIGINAL ONE-PIECE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE ONE-PIECE LENS WHICH WAS INSERTED FIRST AND REMOVED DURING THE SAME PROCEDURE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE THREE-PIECE LENS WHICH TOO WAS INSERTED AND REMOVED FROM PATIENT'S EYE AND THE EVENT OF VITRECTOMY WILL BE CAPTURED IN THAT REPORT.

  Patient problems: Capsular Bag Tear

  MAUDE report 13831829 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THAT A JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 12837911 ↗
• InjuryOct 19, 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 FULLY INSERTED AND REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO CAPSULE TEAR. PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12662158 ↗
• MalfunctionSep 30, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS BENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558477 ↗
• InjuryAug 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO LENS GETTING DISLOCATED. ALSO PPV AND LIMBAL RELAXATION INCISIONS WERE DONE AT THE TIME OF EXPLANT. PATIENT WAS REFERRED ON DAY 1 POST OP FOR A DISLOCATED IOL THROUGH THE POSTERIOR CAPSULE DURING SURGERY AND DOCTOR'S REPORT STATES THAT ANTERIOR CAPSULE APPEARS TO BE INTACT, LENS DISLOCATED BEHIND THE POSTERIOR CAPSULE IN ANTERIOR VITREOUS, POSTERIOR CAPSULE WAS DISRUPTED. ADDITIONAL DETAILS RECEIVED STATES THAT DISLOCATION HAPPENED AT THE TIME OF SURGERY. THERE WAS NO PATIENT INJURY. INCISION WAS NOT ENLARGED TO REMOVE THE LENS FROM PATIENT'S EYE AND ALSO NO SUTURES WERE DONE. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL (ZA9003), ZA9003 SAME DIOPTER LENS. PATIENT OUTCOME WAS GOOD AND NO PATIENT INJURY WAS REPORTED. SUSPECT PRODUCT HAS BEEN DISCARDED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12369150 ↗