TECNIS IOL ZCB00 (REF ZCB0000170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474531659), received between Aug 29, 2016 and Oct 22, 2025 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A MONOFOCAL INTRAOCULAR LENS (IOL), THE PATIENT STATES THAT HE IS UNABLE TO SEE CLEARLY AT BOTH DISTANCE AND NEAR. HE NEEDS TO HOLD HIS PHONE AT ARM'S LENGTH TO READ IT SOMEWHAT AND EXPERIENCES HALOS AND GHOSTING. ADDITIONAL INFORMATION REVEALED THAT THE LENS WAS EXPLANTED AND REPLACED WITH AN IOL FROM ANOTHER COMPANY. THE PATIENT IS NOW DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 23359042 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE UNDERWENT CATARACT SURGERY ON HER RIGHT EYE ON (B)(6) 2019, DURING WHICH A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED. ABOUT THREE TO FOUR WEEKS AFTER HER SURGERY, THE PATIENT BEGAN EXPERIENCING EYE PAIN PROMPTING HER TO CONTACT HER DOCTOR. THE PATIENT RECEIVED MULTIPLE EYE DROPS AND UNDERWENT A FEW PROCEDURES; HOWEVER, HER SYMPTOMS PERSISTED LEADING TO THE LOSS OF VISION IN HER RIGHT EYE. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A RETINA SPECIALIST FOR FURTHER EVALUATION. IN (B)(6) 2019, THE PATIENT RECEIVED TREATMENT FOR HER EYE, WITH THE DOCTOR SUSPECTING SCAR TISSUE AND MENTIONING THE REMOVAL OF "DEBRIS" FROM THE EYE. HER VISION TEMPORARILY RETURNED FOR ONE DAY BUT WAS LOST AGAIN SHORTLY AFTERWARD. THE PATIENT REMAINS UNCERTAIN ABOUT THE SPECIFIC TREATMENTS SHE RECEIVED. INITIALLY, THE PATIENT WAS TOLD HER CONDITION WAS DUE TO A BACTERIAL INFECTION. HOWEVER, SUBSEQUENT TESTING INDICATED IT WAS A FUNGAL INFECTION (ASPERGILLUS INFECTION) WHICH DID NOT RESPOND TO MEDICATION. THERE IS NO CONFIRMED LINK BETWEEN THE INTRAOCULAR LENS AND THE INFECTION. THE PATIENT STATED THAT SHE DID NOT HAVE PRE-EXISTING HIGH INTRAOCULAR PRESSURE (

  Patient problems: Endophthalmitis; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 23103185 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) MODEL ZCB00 WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF PATIENT DID NOT TOLERATE MONOVISION. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A JNJ LENS MODEL DIU225 12.0 DIOPTER. THE DECISION TO EXPLANT THE IOL WAS NOT DUE TO A PRODUCT QUALITY ISSUE. THERE WAS NO CAPSULE TEAR, NO INCISION CHANGE, NO INJURY, NO SUTURES, AND NO VITRECTOMY. PATIENT PROGNOSIS LENS EXCHANGE WAS REPORTED AS 20/20. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 19639960 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT ZCB00 INTRAOCULAR LENS WAS IMPLANTED AND REMOVED. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR OTHER SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17371740 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THE ZCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED DURING THE PROCEDURE. 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 15955286 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO THE SURGEON MISSING HIS REFRACTIVE TARGET. THERE WAS NO SUTURE, INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. PATIENT WAS DOING FINE POST-EXCHANGE. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/70. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/70. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/30. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11891172 ↗
• MalfunctionMay 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO LENS ARM (HAPTIC) BROKE OFF. SUTURES WERE REQUIRED. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO VITRECTOMY AND NO INCISION ENLARGEMENT PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816175 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERGONE CATARACT SURGERY AND GOT IMPLANTED TECNIS. IN FIRST FOLLOW-UP VISIT, INFECTION WAS SEEN IN PATIENT'S OPERATED EYE. PATIENT WAS GIVEN INTRA VITEREAL ANTIBIOTIC AND NOW PATIENT HAS BEEN CALLED FOR FOLLOW-UP. LENS REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Infections

  MAUDE report 11766804 ↗
• InjuryJul 10, 2020Adverse 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 PATIENT'S RIGHT EYE DUE TO POOR VISION WHICH WAS SPECIFICALLY BECAUSE OF LEFT OVER ASTIGMATISM AND BLURRY VISION AFTER CATARACT SURGERY. THE SUSPECT IOL WAS REPLACED WITH ZCU375, 12.0 DIOPTER POWER LENS. IT WAS NOTED THAT SUTURES WERE REQUIRED. PATIENT IS VERY HAPPY WITH THEIR VISION: 20/20 -1 UNCORRECTED AFTER EXCHANGE. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10256494 ↗
• MalfunctionDec 12, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9455939 ↗
• InjuryMay 24, 2019Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DOCTOR IMPLANTED A ZCB00 INTRAOCULAR LENS (IOL) IN THE CAPSULAR BAG OF THE PATIENT'S EYE. IT WAS LATER FOUND THAT THERE WAS A CRACK IN OPTIC ZONE OF THE LENS. THIS WAS CONFIRMED TO NOT HAVE COME FROM THE FORCEPS. THE LENS WAS REMOVED FROM THE EYE WITH AN INCISION ENLARGEMENT TO 3.0MM FROM THE ORIGINAL INCISION SIZE OF 2.75MM. THERE WAS NO SECONDARY SURGICAL OR MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8642529 ↗
• InjuryMay 24, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE, DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCES. REPORTEDLY, THE INCISION WAS ENLARGED, HOWEVER, THE PATIENT HAS RECOVERED. THE LENS WAS REPLACED WITH THE A DIFFERENT MODEL, AND DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8641033 ↗
• InjuryApr 21, 2019Adverse 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 RIGHT EYE DUE TO UNEXPECTED POST-OP REFRACTION. IT WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8534305 ↗
• InjuryAug 2, 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 +17.0 DIOPTER) WAS EXPLANTED IN SECONDARY PROCEDURE FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING UNFAVORABLE VISION OUTCOME AND INABILITY FOR THE PATIENT TO TOLERATE EMMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO PATIENT INJURY. LENS WITH MODEL ZCB00 +19.5 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING FINE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7745512 ↗
• InjuryMar 15, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT WAS HAVING AN INTRAOCULAR LENS (IOL) EXCHANGE IN THE RIGHT EYE AS IT WAS SUPERIORLY DISPLACED. THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY. DURING FOLLOW UP, IT WAS REPORTED THAT INSTEAD OF AN IOL EXCHANGE, THE DOCTOR PERFORMED AN IOL ROTATION SURGERY. THE IOL REPOSITIONING SURGERY WAS PERFORMED ON (B)(6) 2018. THE IOL ROTATION WAS NOT GREATER THAN 10 DEGREES. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS DOING FINE WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7344211 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HYPEROPIC SHIFT AND WOULD UNDERGO AN INTRAOCULAR LENS (IOL) EXCHANGE ON THE LEFT EYE ON (B)(6) 2018 DUE TO DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINT REPORTER REVEALING THAT THIS SURGERY HAS BEEN CANCELLED/POSTPONED AS THE PATIENT IS NOT MEDICALLY STABLE TO PROCEED WITH SURGERY. THE REASON FOR THE PATIENT¿S CONDITION IS NOT RELATED TO THE USE OF A JOHNSON AND JOHNSON SURGICAL VISION PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7333246 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND WAS LATER EXPLANTED. THE REASON FOR EXPLANT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7253005 ↗
• MalfunctionDec 13, 2017Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED OR DIRTY WHEN OPENED FROM THE STERILE PACKAGE. REPORTEDLY, ANOTHER LENS WAS USED FOR THE SURGERY. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7114154 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PHYSICIAN HAD TO PERFORM A VITRECTOMY AND REPLACE THE ZCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) AS THERE WAS A LEAK (VITREOUS LEAK) WITH THE PATIENT'S EYE. THE ZCB00 LENS WAS REPLACED WITH A 3-PIECE LENS. THROUGH FOLLOW UP CLARIFICATION WAS PROVIDED. WHEN THE LENS WAS INSERTED INTO THE EYE THE PHYSICIAN NOTICED THAT THERE WAS A TEAR IN THE CAPSULAR BAG. THE PHYSICIAN WAS UNSURE IF THE TEAR WAS DUE TO THE IOL OR PATIENT ANATOMY. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE ZCB00 IOL, A VITRECTOMY WAS CONDUCTED AND THE LENS WAS REPLACED WITH A BACK-UP IOL. THERE WAS NO POST-OP PATIENT INJURY. IT WAS NOTED THE DEVICE WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy; Vitreous Loss

  MAUDE report 6679910 ↗
• MalfunctionApr 3, 2017Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE AND THE LENS WAS CRACKED WHERE THE HAPTIC MEETS THE OPTIC. REPORTEDLY, THERE WAS NO PLAN TO EXPLANT THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455420 ↗
• MalfunctionMar 30, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING IMPLANTATION OF A ZCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL), THE PHYSICIAN OBSERVED A DEFECT ON THE CENTER OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6448264 ↗
• InjuryAug 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCB00 INTRAOCULAR LENS (IOL), A PATIENT EXPERIENCED A PROBLEM SEEING BOTH DISTANCE AND READING WITH A LOT OF FUZZINESS. REPORTEDLY, PATIENT HAS SEEN MANY DIFFERENT SURGEONS AND OPTOMETRIST AND THEY HAVE GIVEN HER CONTACTS LENSES AND GLASSES. PATIENT HAD YAG IN (B)(6) 2016, AND PATIENT CAN DRIVE THOUGH MOST OF THE LETTERS ARE STILL FUZZY AND SHE NEEDS GLASSES WHEN USING THE COMPUTER. REPORTEDLY, PATIENT DID NOT HAVE ANY SERIOUS MEDICAL CONDITION. PATIENT PLANS TO SEE ANOTHER DOCTOR FOR HER VISUAL CONCERNS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 5912771 ↗