TECNIS IOL ZCB00 (REF ZCB0000165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474531642), received between Feb 3, 2017 and Dec 4, 2025 — classified as 16 injuries, 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 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 23713058 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATIONS AND THE OCCURRENCE OF OPTICAL APPARITIONS IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO ADDITIONAL SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. THE PATIENT'S OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23341507 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED DURING A CASE. FOLLOW-UP WAS PERFORMED BUT THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243467 ↗
• InjuryMay 5, 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 FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE DUE TO POSTERIOR RENT NOTED AFTER INSERTION. UNPLANNED VITRECTOMY AND SUTURES PERFORMED. SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16879927 ↗
• InjurySep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND PROLAPSED. A VITRECTOMY PERFORMED AND THE EXACT SAME LENS WAS RE-IMPLANTED IN THE EYE; AFTERWARDS, THE LENS DECENTERED. PATIENT REPORTED HIS VISION IS POOR, CURRENTLY 20/400. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Vitrectomy

  MAUDE report 10570864 ↗
• InjuryApr 15, 2020Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S RIGHT EYE AND THEN REMOVED DUE TO BENT/ BROKEN HAPTIC. IT WAS STATED THAT THERE AN INCISION ENLARGEMENT WAS REQUIRED. HOWEVER, THE PATIENT HAS RECOVERED. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9961148 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2020. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO BLURRY VISION. THE PATIENT VISUAL ACUITY (VA) PRE-OP WAS 20/40-2 AND (VA) POST-OP IS 20/40. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE CUSTOMER ALSO INDICATED THAT THE LENS HAD BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9946295 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00, 16.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO UNEXPECTED POST REFRACTION. THE IOL WAS REPLACED WITH A MODEL ZCT300 +9.0 DIOPTER LENS. THERE WERE NO COMPLICATIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9239798 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +16.5 DIOPTER) WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED AND THE LENS WAS DISCARDED. THE REPLACEMENT LENS WAS A MODEL AR40E +15.5 DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8853932 ↗
• InjuryJul 4, 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 AS THE PATIENT WAS SEVERELY ANISOMETROPIC POST IMPLANT. VISUAL ACUITY PRE-OP WAS CF (COUNTING FINGERS) AND VISUAL ACUITY POST-OP WAS PH (PIN HOLE) 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8761888 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD MYOPIC SURPRISE AND DECREASED VISUAL ACUITY AFTER THE IMPLANTATION OF MODEL ZCB00 +16.5 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) IN HIS LEFT EYE (OS). AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH MODEL PCB00 +15.0 DIOPTER IOL. REPORTEDLY, THE PATIENT WAS DOING GOOD WHEN DISCHARGED AND THERE WAS NO SECONDARY INTERVENTION REQUIRED SUCH AS SUTURE, INCISION ENLARGEMENT AND VITRECTOMY DURING THE LENS EXCHANGE. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/200, VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/70, VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/60. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8247396 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A MODEL ZCB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN HIS RIGHT EYE (B)(6) 2018. THROUGH FOLLOW-UP, THE PATIENT REPORTED DYSPHOTOPSIA CONSISTING OF HALOS THAT WILL NOT GO AWAY (WAS FIRST NOTICED ON (B)(6) 2018). THIS SYMPTOM REPORTEDLY AFFECTS HIS DAILY LIFE; MAKES IT HARD TO SEE CLEARLY, ESPECIALLY AT NIGHT. THE LENS REMAINS IMPLANTED AND THERE IS NO INDICATION OF ANY PLANNED OR PERFORMED INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC.

  Patient problems: Halo; No Code Available

  MAUDE report 8035702 ↗
• InjuryAug 15, 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 TORN WHILE INSERTING A ZCB00 16.5 DIOPTER LENS INTO THE PATIENT'S OPERATIVE EYE. THERE WAS AN INCISION ENLARGEMENT MADE, A VITRECTOMY PERFORMED, AND A SUTURE WAS USED. THE REPLACEMENT LENS WAS MODEL Z9002 WITH AN UNKNOWN DIOPTER POWER. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7787657 ↗
• InjuryJul 11, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00, +16.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE PATIENT¿S RIGHT EYE. REPORTEDLY, THE LENS MODEL ZCB00, +19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. THE PATIENT WAS REPORTED DOING NORMAL WHEN DISCHARGED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7676821 ↗
• MalfunctionApr 24, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE LENS WOULD NOT FULLY COME OUT OF THE CARTRIDGE AND WAS PARTIALLY DELIVERED INTO THE LEFT EYE DUE TO POSSIBLE LOADING ERROR. ANOTHER LENS WAS USED. THERE WAS NO NEED FOR INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455063 ↗
• MalfunctionApr 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DOCTOR NOTICED A SPECK ON THE LENS. THERE WAS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Patient Involvement

  MAUDE report 7436264 ↗
• MalfunctionMar 16, 2018Crack; Crack

  IT WAS REPORTED THAT IMMEDIATELY AFTER TAKING OUT THE INTRAOCULAR LENS (IOL) FROM THE LENS CASE, THE LENS STARTED CRACKING THROUGH THE WHOLE DIAMETER OF THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7344221 ↗
• MalfunctionSep 20, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT A ZCB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) CRACKED (TORE) AFTER IT WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THERE WAS NO SURGICAL INTERVENTION OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881250 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 16.5 DIOPTER WAS IMPLANTED ON (B)(6) 2017 AND LATER EXPLANTED ON (B)(6) 2017 BECAUSE OF A MYOPIC SHIFT. THE LENS WAS REPLACED WITH THE SAME MODEL NUMBER, BUT DIFFERENT DIOPTER OF 14.0. THE PATIENT WAS REPORTED TO BE PERFECTLY FINE AND NO ISSUES WERE OBSERVED POST EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6840507 ↗
• InjuryMay 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCB00, 20 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE (OS) AS THE PATIENT NEEDED ASTIGMATISM CORRECTION AND NEEDED A DIFFERENT LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED AND NO SUTURES WERE REQUIRED. THERE WAS NO POST-OP PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6553378 ↗
• MalfunctionApr 20, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED. REPORTEDLY, THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6509120 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION OF A ZCB00 16.5 DIOPTER INTRAOCULAR LENS (IOL), A HOLE WAS OBSERVED IN CAPSULE. DUE TO THE HOLE, THE PHYSICIAN REMOVED THE LENS AND REPLACED IT WITH A MODEL ZA9003 IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO POST-OP PATIENT INJURY REPORTED. CUSTOMER COULD NOT CONFIRM IF THE HOLE WAS DUE TO PATIENT ISSUE OR IF WAS DUE TO THE LENS IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6301432 ↗