TECNIS IOL ZCB00 (REF ZCB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474531666), received between Mar 16, 2017 and Dec 17, 2025 — classified as 18 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED INTRAOCULAR LENS (IOL) HAD BEEN IMPLANTED, BUT THE CAPSULAR BAG WAS FOUND TO BE UNSTABLE DUE TO INTRAOPERATIVE ZONULODIALYSIS. CONSEQUENTLY, THE SURGEON EXPLANTED THE IOL AND REPLACED IT WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 23829883 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE IMPLANTING INTRAOCULAR LENS (IOL) IN THE EYE, THERE WAS POSTERIOR CAPSULE RUPTURE. IOL WAS CHANGED TO A NEW ONE TO COMPLETE THE IOL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22396492 ↗
• MalfunctionJul 17, 2024Break; Break

  IT IS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS NOTED AFTER INSERTION. DEFECTIVE LENSES IS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER MANUFACTURER'S IOL. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S STATUS IS GOOD. A DEFECTIVE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766151 ↗
• MalfunctionAug 30, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE NON-PRELOADED MONOCULAR INTRAOCULAR LENS (IOL) HAD A SCRATCH ON IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651005 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED IN / OUT OF AN INTRAOCULAR LENS (IOL). AFTER CATARACT EXTRACTION, A LENS THAT WAS COMPLETELY IMPLANTED IN A PATIENT'S LEFT EYE (OS) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS THE SURGEON WAS CONCERNED WITH THE INTEGRITY OF THE POSTERIOR CAPSULE (PC) BAG / ZONULES; THEREFORE, USED A 3-PIECE LENS, MODEL ZA9003 OF 16.5 DIOPTER AS A REPLACEMENT. IT WAS CONFIRMED THAT THERE WAS NO PRODUCT QUALITY ISSUE. THERE WAS OTHER MEDICAL / SURGICAL INTERVENTION REQUIRED: AC TAP WAS PERFORMED X2 (1 HOUR APART) TO LOWER INTRAOCULAR PRESSURE (IOP) AS IT WAS SLIGHTLY ELEVATED; 5% BETADINE WAS PLACED PRIOR TO BOTH AC TAPS, AND A DROP OF MOXIFLOXACIN WAS PLACED AFTER BOTH PILOCARPINE 1% 1DROP TWICE A DAY (BID) OS X2 DAYS (TO HELP CLEAR ANY REMAINING VISCOAT). THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased; Zonular Dehiscence

  MAUDE report 17647141 ↗
• MalfunctionApr 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TORN UPON DISCHARGE OF LENS FROM INSERTER. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733060 ↗
• MalfunctionOct 13, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THERE WAS A DEPLOYMENT ISSUE WITH THE INTRAOCULAR LENS (IOL). THE IOL WAS NOT INSERTED AND THE PATIENT WAS UNHARMED. A SULCUS IOL WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601906 ↗
• MalfunctionJul 20, 2022Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED IN THE CARTRIDGE AND A SCRATCH WAS NOTED ON THE LENS AFTER INSERTING THE IOL INTO THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067134 ↗
• InjuryApr 7, 2022Adverse 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 OPERATIVE EYE IN A SECONDARY SURGERY. THE REASON FOR THE LENS EXCHANGE WAS NOT PROVIDED. THE LENS WAS DESTROYED AFTER THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 14048643 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED AN EXPLANT ON PATIENT'S LEFT EYE (OS). NO PATIENT INJURY REPORTED. DIFFERENT MODEL AND DIOPTER WAS USED. THERE IS NO LENS TO RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013455 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THERE WAS A BROKEN LENS IN THE EYE. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780416 ↗
• InjuryApr 12, 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 DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLICATIONS WITH THE IOL AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING COMPLICATIONS WITH IOL AS PATIENT SUFFERED TRAUMA OD AFTER CE/IOL RESULTING IN SUBLUXATED LENS. IT WAS ALSO CONFIRMED THE INCISION WAS ENLARGED DURING IOL EXPLANT PROCEDURE, THERE WAS ALSO A PLANNED VITRECTOMY, AND THERE WERE NO UNPLANNED SUTURE(S). PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS DOING WELL AND VISION CORRECTABLE TO 20/20. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11649091 ↗
• MalfunctionNov 18, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), ONE SIDE OF THE LENS HAPTIC WAS STUCK IN THE CARTRIDGE. THE DOCTOR USED OPHTHALMIC MICRO TWEEZERS TO HOLD THE LENS HAPTIC AND COMPLETED THE IOL IMPLANT OPERATION SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858048 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN IOL EXPLANTED FROM RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Injury; No Code Available

  MAUDE report 10840315 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE BECAUSE SHE IS NOT AS NEARSIGHTED AS SHE WOULD LIKE DURING POST-OP EXAM. THE REPLACEMENT IOL IS OF THE SAME MODEL WITH A HIGHER DIOPTER, (20.0). THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED, AND NO INJURY WAS REPORTED. VISUAL ACUITY PRE-OP, WITH CORRECTION (CC) 20/30 NEAR VISUAL ACUITY (NVA). VISUAL ACUITY POST-OP, SANS CORRECTION (SC) 20/25 NVA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10318598 ↗
• MalfunctionJun 29, 2020Contamination; Contamination

  THE CUSTOMER IMPLANTED A TECNIS 1-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT (OS) EYE. AT ONE DAY POST-OP, THE CUSTOMER OBSERVED A ¿STICKY SUBSTANCE¿ ADHERING TO THE POSTERIOR SIDE OF THE LENS THROUGH A SLIT LAMP. THE POSTERIOR ASPECT OF THE LENS HAS WHAT APPEARED A STRING-LIKE SUBSTANCE BLUISH IN COLOR, ADHERED TO THE MIDDLE OF THE OPTIC. THE CUSTOMER HAD TO WORK HARD AT REMOVING IT OFF THE LENS. THE LENS REMAINS IMPLANTED SINCE THE PATIENT'S VISION HAS NOT BEEN IMPACTED. THERE IS NO INDICATION THAT A PLANNED TREATMENT HAS BEEN SCHEDULED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10210362 ↗
• InjuryApr 9, 2020Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING 1.5 HYPEROPIC SURPRISE. THERE WAS NO PATIENT INJURY. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9946399 ↗
• InjuryMar 26, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT (OD) EYE UPON INSERTION WHEN THE SURGEON NOTICED A SCRATCH ON THE LENS. INCISION WAS ENLARGED ALONG WITH ONE SUTURE USED DURING THE PROCEDURE. THE CURRENT PATIENT STATUS WAS REPORTED AS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9886607 ↗
• MalfunctionMar 26, 2020Contamination; Contamination

  IT WAS REPORTED ZCB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE AND THERE WAS A FILM STUCK ON THE POSTERIOR SIDE OF THE OPTIC. THE DOCTOR WAS ABLE TO REMOVE THE FILM BY GOING UNDERNEATH THE LENS AND USING THE IRRIGATION/ASPIRATION (I/A) HANDPIECE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9881818 ↗
• InjuryOct 14, 2019Adverse 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 NOT IMPLANTED BECAUSE THE PATIENT'S CAPSULE BROKE. A REMOVAL AND REPLACEMENT WAS SUCCESSFULLY COMPLETED DURING THE INITIAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 9184089 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE LEFT EYE OF THE PATIENT WITHIN THE INITIAL PROCEDURE. REPORTEDLY, THE SURGEON NOTICED THAT THE PATIENT POSTERIOR CAPSULE WAS TORN, MAKING IT UNSAFE TO LEAVE THE LENS IMPLANTED. INCISION ENLARGEMENT AND VITRECTOMY WERE PERFORMED. PATIENT OUTCOME WAS NOTED AS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 8291853 ↗
• MalfunctionJan 21, 2019Scratched Material; Failure to Eject; Scratched Material; Failure to Eject

  IT WAS REPORTED THAT WHEN INSERTING A ZCB00 INTRAOCULAR LENS (IOL) INTO THE EYE, THE IOL WAS SCRATCHED WHEN TRYING TO PUSH OUT OF CARTRIDGE. THE IOL WAS DISCARDED. THE IOL WAS ALSO REPORTED AS BEING STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION RECEIVED REVEALED ONLY THE CARTRIDGE MADE CONTACT WITH THE PATIENTS EYE, NO SECONDARY INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265549 ↗
• MalfunctionNov 15, 2018Contamination; Contamination

  IT WAS REPORTED THAT A SMALL FILAMENT WAS NOTICED INSIDE THE PATIENT'S EYE AFTER IMPLANTING A MODEL ZCB00 +17.5 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS). THE DOCTOR SUCCESSFULLY REMOVED THE FILAMENT. THERE WAS NO PATIENT INJURY. THE CUSTOMER SUSPECTED THAT 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 8072724 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ONE (1) WEEK AFTER THE IMPLANTATION OF ASPHERICAL INTRAOCULAR LENS (IOL). PER ACCOUNT, THE HOSPITAL SELF-CHECKED THE ASEPTIC STATUS IN THE OPERATING ROOM AND USED ALL SURGICAL DEVICE AND TOOLS FOR BACTERIAL SAMPLING AND CULTURE. THE HOSPITAL USED TWO DIFFERENT MODEL ZCB00 LENSES FOR CULTURING AND PERFORMED SWAB. INITIAL BACTERIA CULTURE REPORT SHOWS PRESENCE OF BACTERIA. THE PATIENT IS CURRENTLY UNDERGOING ANTI-INFECTIVE TREATMENT IN OTHER HOSPITALS. PER FOLLOW-UP INFORMATION, THE HOSPITAL HAS VERBALLY COMMUNICATED THAT AFTER A SERIES OF RETESTS, THEY DID NOT FIND BACTERIA AND THERE IS NO SUSPICION ON IOL PRODUCT. THEY CONDUCTED INVESTIGATION FOR POSITIVE BACTERIAL TEST RESULTS AND IDENTIFIED THE RESULTS ARE NOT ASSOCIATED WITH JOHNSON & JOHNSON SURGICAL VISION PRODUCTS. THERE IS NO ISSUE ABOUT PRODUCT STERILITY AND THEY RESUMED USAGE OF THE IOL PRODUCTS. THEY DECLINED TO SHARE FURTHER DETAILS OF THE CASE. TWO (2) PATIENTS HAVE RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Bacterial Infection

  MAUDE report 7544967 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT WAS SEEING HALOS, RAYS AND LINES POST IMPLANT OF A ZCB00 17.5 DIOPTER INTRAOCULAR LENS IN THE LEFT EYE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 7517153 ↗