TECNIS IOL ZCB00 (REF ZCB0000255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474531826), received between Oct 20, 2016 and Jun 13, 2025 — classified as 17 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A 25.5 DIOPTER ZLB00 MODEL LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22207468 ↗
• InjuryDec 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FULLY INSERTED NON-PRELOADED INTRAOCULAR LENS (IOL) WAS UNSTABLE UPON INSERTION INTO THE LEFT EYE. AS A RESULT, THE DOCTOR OPTED TO REMOVE THE INITIAL LENS AND REPLACE IT WITH A THREE-PIECE LENS DURING THE SAME PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, UNPLANNED SUTURES, OR DELAY IN TREATMENT. AN UNPLANNED VITRECTOMY WAS PERFORMED. THE END-USER DID NOT SEEK MEDICAL ATTENTION AND NO MEDICATION WAS PRESCRIBED OUTSIDE OF STANDARD CARE. DAILY ACTIVITIES WERE NOT AFFECTED. IT IS NOTED THAT THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE VITRECTOMY WAS PERFORMED BECAUSE THE SURGEON NOTICED THERE WAS AN OPENING IN THE POSTERIOR CHAMBER WHEN INSERTING THE LENS. PER THE CUSTOMER, THE JOHNSON & JOHNSON DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21044797 ↗
• MalfunctionSep 25, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOMER ORDERED A ZCB00 LENS AND THE BOX ARRIVED SEALED. WHEN THE CUSTOMER OPENED THE MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, 25.5 DIOPTER BOX, NOTICED THAT THE DAISY WHEEL THAT CONTAINS THE LENS WAS LABELED AS AR40E, +25.5 DIOPTER. IT WAS CONFIRMED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED, NO INJURY TO THE PATIENT REPORTED AS A RESULT OF THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307024 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) (ZLB00, 23.5 DIOPTER) WAS EXPLANTED FROM THE LEFT EYE FOR AN UNKNOWN REASON. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZCB00, 25.5 DIOPTER), WHICH RESULTED IN A CAPSULE TEAR. THE ZCB00 REPLACEMENT LENS WAS IMMEDIATELY REMOVED FROM THE LEFT EYE AND A VITRECTOMY WAS PERFORMED. A 3-PIECE NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE ZCB00 IOL. A SEPARATE REPORT WILL CAPTURE THE EVENT FOR THE ZLB00 IOL.

  Patient problems: Capsular Bag Tear

  MAUDE report 19952320 ↗
• MalfunctionMay 14, 2024Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER PROVIDED PHOTOS OF AN INTRAOCULAR LENS (IOL) WITH SHOWING LENS WITH PART OF THE STEM SEVERED (LENS AND HAPTIC WERE DAMAGED). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307517 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC ON THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS TORN. THE IOL WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH A NON JNJ MODEL. THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, CAPSULE TEAR, VITRECTOMY OR SUTURES. THE SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875341 ↗
• InjuryMay 25, 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 EYE DUE TO NEGATIVE DYSPHOTOPSIA. THE INCISION WAS ENLARGED, HOWEVER, THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14494303 ↗
• MalfunctionFeb 24, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION CLARIFIED THAT DURING THE OPERATION THE LENS WAS IMPLANTED AND UNDER THE MICROSCOPE, THE SURGEON SAW THAT THE OPTIC WAS SCRATCHED. THE LENS WAS THEN TAKEN OUT OF THE EYE AND A NEW ONE WAS PUT IN. THE PATIENT WAS NOT HARMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596574 ↗
• MalfunctionJun 8, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT WHEN A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS FOLDED IT HAD A CREASE IN IT AND WAS DESTROYED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE EVENT WAS OBSERVED WHEN INSERTING LENS INTO THE EYE. THE LENS WAS PARTIALLY INSERTED BUT THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE PERFORMED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963217 ↗
• MalfunctionMay 5, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE (OS), DUE TO A BENT/BROKEN HAPTIC. THE HAPTIC BROKE OFF DURING INSERTION. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775193 ↗
• InjuryApr 7, 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 FROM PATIENT'S OPERATIVE EYE DUE TO ANISOMETROPIA .THERE WAS NO PATIENT INJURY OR WOUND ENLARGEMENT. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL AND DIFFERENT DIOPTER LENS. ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ISSUE WITH THE LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11632122 ↗
• MalfunctionOct 9, 2020Break; Contamination; Packaging Problem; Break; Contamination; Packaging Problem

  CUSTOMER REPORTED THIN LINEAR WHITISH ADHESIONS ON THE OPTICS OF THE INTRAOCULAR LENS (IOL), USUALLY ONE AND SOMETIMES TWO IN A PARALLEL ORIENTATION. THE DOCTOR IS USUALLY ABLE TO SUCTION THE ADHESIONS OFF OF THE POSTERIOR FACE OF THE OPTIC. SOMETIMES HE HAS TO USE A SINSKI HOOK TO LOOSEN THEM OFF TO BE ASPIRATED. THE DOCTOR REPORTED HAVING TROUBLE EXPRESSING A FEW IOLS FROM THE CARTRIDGES. THE LENSES WERE EXPRESSED OUTSIDE OF THE EYE AND THEN RELOADED BECAUSE IT WAS VERY DIFFICULT TO USE THE SCREW MECHANISM AND THE CARTRIDGES APPEARED TO HAVE STRESS MARKS. PER THE DOCTOR, IT MAY BE THE NON-JOHNSON & JOHNSON CARTRIDGES USED. HOWEVER, ONE OF THE IOLS TORE. THRU FOLLOW-UP WE WANTED TO CONFIRM IF THE DOCTOR INSPECTED THE IOL PRIOR TO INSERTING IT INTO THE CARTRIDGE. WE ASKED IF THE J&J IOL HAD DEBRIS PRIOR TO CARTRIDGE INSERTION. THE RESPONSE FROM THE J&J ACCOUNT EXECUTIVE WAS THAT HE DOES NOT THINK THERE WAS DEBRIS PRIOR TO INSERTION. ADDITIONALLY THE CUSTOMER WAS USING NON-J&J CARTRIDGES. THE CUSTOMER CLARIFIED THAT THERE WERE NO PROBLEMS WITH THE SCREW MECHANISM. ADDITIONALLY, THE CUSTOMER REPORTED THEY HADN'T HAD THAT PROBLEM IN THE PAST. THEY EXPLAINED THAT THERE ARE OTHER LOCATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10654224 ↗
• MalfunctionOct 14, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS PREMATURELY EJECTED INTO THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184090 ↗
• InjurySep 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DOCTOR HAD AN ISSUE WITH ZCB00 INTRAOCULAR LENS (IOL). THE HAPTICS STICK TOGETHER FOR 2-3 MINUTES IN A CASE AND THE DOCTOR TRIED TO GET THEM UNSTUCK BUT ENDED UP PUNCTURING THE CAPSULE WITH A 2ND INSTRUMENT LEADING TO A VITRECTOMY AND PLACEMENT OF AN ANTERIOR CHAMBER (AC) LENS. SEVERAL FOLLOW-UPS WERE PERFORMED TO TRY TO ASK FOR MORE CLARIFICATION AND ALSO OBTAIN MORE INFORMATION BUT THERE WAS NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9131341 ↗
• MalfunctionAug 6, 2019Contamination; Contamination

  IT WAS REPORTED THAT FOREIGN OBJECT, PLASTIC-LIKE CLEAR PIECE WAS SEEN ON THE SURFACE OF AN INTRAOCULAR LENS (IOL), MODEL ZCB00 ONCE THE LENS WAS IMPLANTED IN THE EYE. THE ISSUE WAS NOTED ON TWO ZCB00 LENSES IMPLANTED IN TWO DIFFERENT PATIENTS. IT WAS INDICATED THAT THE FOREIGN OBJECT WAS IN THE SAME POSITION AND SAME CONSISTENCY ON BOTH IMPLANTS AND THAT ON BOTH PATIENTS, THE FOREIGN OBJECT WAS ABLE TO BE REMOVED. REPORTEDLY, THE FOREIGN OBJECT WAS DISPOSED AND IT IS NOT AVAILABLE FOR RETURN. THERE WAS A FIVE (5) MINUTES DELAY IN THE PROCEDURES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LENS IMPLANTED IN THE FIRST PATIENT'S EYE. A SEPARATE REPORT WILL BE SUBMITTED ON THE LENS IMPLANTED IN THE SECOND PATIENT'S EYE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863089 ↗
• InjuryJul 31, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE EYE, GOT STUCK IN CARTRIDGE. IT WAS STATED THAT THERE WAS RESISTANCE WHEN TRYING TO ADVANCE THE IOL INTO EYE. THERE WAS PATIENT CONTACT. INCISION WAS ENLARGED WHEN LENS WAS REMOVED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8844491 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S VISION WAS TARGETED AT PLANO, BUT PATIENT WAS AT -2.00 INSTEAD AFTER IMPLANTATION OF 25.5 DIOPTER INTRAOCULAR LENS (IOL) MODEL, ZCB00. REPORTEDLY, THERE WAS NOTHING IN PATIENT'S CHART OR POSTOPERATIVE WOULD EXPLAIN THIS RESULT. THROUGH FOLLOW UP, THE DOCTOR REPORTEDLY RESPONDED THAT PATIENT HAD AQUEOUS DIRECTION, BUT SHE IMPROVED ON ATROPINE. THE PATIENT'S EXAMINATION RESULTS: PREOPERATIVE VISION: +1.50 -1.50X90 20/25. POSTOPERATIVE VISION: -1.00 SPH (ON ATROPINE) 20/20 WITHOUT -2.25 SPH 20/20. REPORTEDLY, THE PATIENT HAD NARROW ANGLES WITH PAS (PERIPHERAL ANTERIOR SYNECHIAE) S/P LI (LASER IRIDOTOMY) WITH NO IMPROVEMENT PREOPERATIVE AND IOP (INTRAOCULAR PRESSURE) WAS HIGH. UMB (ULTRASOUND BIOMICROSCOPY) SHOWED NARROW ANGLES AND NO PLATEAU IRIS. LENS EXTRACTION WAS PERFORMED TO OPEN ANGLES MORE. IT WAS CONFIRMED THAT THE CATARACT SURGERY WAS PERFORMED ON (B)(6) 2019 AND THE ORIGINAL IOL REMAINS IMPLANTED. IT WAS NOTED THAT FOR RETINA PROBLEM THE DOCTOR IS GOING TO DO PPV (PARS PLANA VITRECTOMY) AND THEN WILL MONITOR THE PATIENT'S REFRACTIVE OUTCOME WHEN SHE'S OFF ATROPINE. CURRENTLY, SHE IS STILL ABOUT -1 ON ATROPINE. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: Intraocular Pressure Increased; No Code Available; Vitrectomy

  MAUDE report 8458592 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 25.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING PAIN, DISCOMFORT AND VISUAL DISTURBANCE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. A MODEL ZCB00 24.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT NOTED AS RECOVERED POST EXCHANGE. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Pain; Visual Disturbances

  MAUDE report 8201985 ↗
• MalfunctionNov 15, 2018Contamination; Contamination

  IT WAS REPORTED THAT A SMALL FILAMENT WAS NOTICED INSIDE THE PATIENT'S EYE AFTER IMPLANTING A MODEL ZCB00 +25.5 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS). THE DOCTOR SUCCESSFULLY REMOVED THE FILAMENT. THERE WAS NO PATIENT INJURY. THE CUSTOMER SUSPECTED THAT THE FILAMENT (FOREIGN MATERIAL) MAY BE RELATED TO THE IOL OR WAS INSIDE OF PACKAGING. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072730 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED ZCB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED DURING IMPLANTATION DUE TO IMPROPER LOADING AND EXTENT OF PATIENT CONTACT WAS UNKNOWN. IT WAS REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035713 ↗
• InjurySep 21, 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 BROKE WHEN INSERTING THE ZCB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS). PER SURGEON¿S OPERATIVE REPORT, THE PATIENT'S CATARACT WAS NOTED TO HAVE VERY SHARP EDGES THAT WERE ADHERENT TO THE CAPSULE ITSELF. THE ONE PIECE LENS WAS PLACED AND WAS NOTED TO BE VERY MOBILE AND DISPLACED POSTERIORLY. THE REPLACEMENT LENS WAS A NON J&J INTRAOCULAR LENS. AN INCISION ENLARGEMENT, VITRECTOMY, AND SUTURES WERE REQUIRED DUE TO THE COMPLICATIONS OF THE CAPSULE TEARING. PATIENT WAS DOING FINE POST OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7899359 ↗
• MalfunctionFeb 16, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT THE INSERTER TORE THE INTRAOCULAR LENS DURING INSERTION INTO THE EYE.NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 7278969 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION POST-OPERATIVELY AFTER THE IMPLANTATION OF A ZCB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) IN THEIR LEFT EYE (OS) ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 7145946 ↗
• InjuryNov 14, 2017Break; Break

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) OF THE PATIENT ON (B)(6) 2015. REPORTEDLY, THE PATIENT STATES SHE HAS SUFFERED GREAT PAIN, SUFFERING, AND DISABILITY CAUSING THE PATIENT TO SEEK FURTHER MEDICAL TREATMENT. ALSO, THE SURGERY REPORTEDLY CAUSED DAMAGE TO THE PATIENT'S CORNEA. THE PATIENT IS ALLEGING THAT THE LENS WAS NEGLIGENTLY LOADED AND DAMAGED BEFORE BEING IMPLANTED INTO HER RIGHT EYE. REPORTEDLY, THE TRAILING HAPTIC OF THE INTRAOCULAR LENS DISLODGED UPON DELIVERY REQUIRING REMOVAL OF THE LENS WITHIN THE INITIAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Pain

  MAUDE report 7031456 ↗
• MalfunctionSep 23, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN REMOVING THE INTRAOCULAR LENS (IOL) FROM THE LENS CASE, SOMETHING WAS NOTICED ON THE LENS. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6889131 ↗