TECNIS IOL ZCB00 (REF ZCB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 05050474531765), received between Oct 9, 2016 and Jun 22, 2026 — classified as 66 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Scratched Material

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED WHICH WAS FOUND UPON INSERTION OF THE LENS INTO THE LEFT EYE OF THE PATIENT. IT WAS NOTED THAT THE IMPERFECTION ON THE LENS COULD HAVE RESULTED FROM USER ERROR. THERE WAS NO CARTRIDGE TIP DAMAGE REPORTED. THE LENS WAS IMPLANTED IN THE LEFT EYE OF PATIENT AND THEN REMOVED. A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587445 ↗
• MalfunctionMar 23, 2026Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT TWO NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) EXPERIENCED ISSUES: ONE LENS WAS SCRATCHED, AND THE OTHER BECAME STUCK IN THE LOADER. IT IS UNCLEAR WHICH LENS SERIAL NUMBER (SN) CORRESPONDS TO EACH ISSUE. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LENS WITH SN (B)(6). A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS (SN (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663645 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT THE HAPTIC OF A MONOFOCAL INTRAOCULAR LENS HAD BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318561 ↗
• 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 SUBJECT YTTRIUM ALUMINUM GARNET (YAG) EVALUATION. THE PATIENT CAN PERFORM HER DAILY ACTIVITIES AS SHE DID PRIOR TO THE SURGICAL PROCEDURE. A YAG LASER CAPSULOTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2024. 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 23712442 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGEON NOTICED BURR ON THE EDGE OF THE LENS. IOL REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536561 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED, SINGLE-PIECE SPHERICAL MONOFOCAL INTRAOCULAR LENS (IOL) WITH A POWER OF 22.5 DIOPTERS WAS SURGICALLY IMPLANTED IN A PATIENT ON (B)(6) 2025, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. DURING A REEXAMINATION ON (B)(6) 2025, THE LOOP OF THE LENS WAS FOUND TO BE BROKEN. A SECOND SURGERY WAS PERFORMED IN (B)(6) 2025 TO REMOVE AND REPLACE THE LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439123 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527041 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED AN INCREASE IN NEGATIVE DYSPHOTOPSIA COMPLAINTS ASSOCIATED WITH THE ZCB00 MONOFOCAL INTRAOCULAR LENS (IOL) IN COMPARISON TO TORIC, ZCU MODEL LENSES. THE DOCTOR SPECIFICALLY REPORTED THAT A ZCB00 LENS WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO PATIENT'S COMPLAINT OF TEMPORAL NEGATIVE DYSPHOTOPSIA WHICH THE PATIENT COULD NOT LIVE WITH. THE PATIENT'S CONDITION DID NOT IMPROVE OVER A SPAN OF 5 TO 6 WEEKS. IT WAS INDICATED THAT THE PHACO PROCEDURE WITH THE POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) PROCEEDED SMOOTHLY. THE IOL EXCHANGE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS AND A NON-JOHNSON & JOHNSON WAS USED AS A REPLACEMENT LENS. THE PHYSICIAN INDICATED THAT NO ISSUES OR SIDE EFFECTS ARE ANTICIPATED. THE PATIENT IS SATISFIED WITH THE OUTCOMES FOLLOWING THE IOL EXCHANGE. NOTE: THIS EMDR REPORT CAPTURES THE ISSUES REPORTED REGARDING THE ZCB00 LENS, SN (B)(6). THE EVENT ASSOCIATED WITH THE TORIC ZCU MODEL LENS DOES NOT MEET THE CRITERIA FOR REPORTABLE EVENTS.

  Patient problems: Visual Disturbances

  MAUDE report 22342913 ↗
• InjuryJun 26, 2025Adverse 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) SCRATCHED THE CAPSULAR BAG AND TORE IT. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER JNJ IOL MODEL AR40E WHICH IS A 3 PIECE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22333884 ↗
• InjuryJun 19, 2025Adverse 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) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED DYSPHOTOPSIA WHICH WAS IDENTIFIED DURING A POST-OPERATIVE EXAM. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS, MODEL SOFTEC HDO +21.25. THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT OR VITRECTOMY AND THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22290451 ↗
• MalfunctionMay 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS UNABLE TO UNFOLD AFTER INJECTING INTO PATIENT'S EYE. SURGEON EXPLANTED IT AND USED A BACKUP LENS TO COMPLETE THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989934 ↗
• InjuryMay 6, 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). PATIENT STATED HE DID NOT SEE WITHIN THE FIRST THREE (03) DAYS AFTER SURGERY AND THEN HE HAD BLURRY VISION. HIS VISION PRIOR TO THE SURGERY WAS GOOD. HE WAS PUT ON STEROIDS FOR A YEAR AFTER THE IMPLANT TO GET INFLAMMATION DOWN IN THE MACULA. PATIENT HAD LOW EYE ANGLES AND WAS ADVISED THAT THIS WAS BEING ADDRESSED AND HE COULD HAVE CATARACT SURGERY TOO AND THAT HE WOULD NOT NEED LASIK DONE. HE IS SCHEDULED TO SEE THE DOCTOR AND HAVE A YTTRIUM ALUMINUM GARNET (YAG) DONE IN THREE (03) WEEKS AND THE DOCTOR DISCUSSED PERFORMING A VITRECTOMY AT THIS TIME AS WELL. PATIENT HAS TYPE II DIABETES. HE NOW SEES A RETINA SPECIALIST AND WAS TOLD THE FLUID IS NO LONGER THERE, BUT HE STILL HAS PROBLEMS WITH THE RIGHT EYE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THE YAG AND VITRECTOMY PROCEDURES HAVE NOT BEEN CONFIRMED TO HAVE TAKEN PLACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Macular Edema

  MAUDE report 21965283 ↗
• InjuryJan 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER IMPLANTING A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE LENS TILTED, AND A POSTERIOR CAPSULE RENT WAS NOTED. THE ISSUE WAS FIRST IDENTIFIED AFTER THE LENS WAS FULLY INSERTED. THIS LENS WAS REMOVED DURING THE SAME PROCEDURE AND AN ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL) WAS IMPLANTED. THERE WAS INCISION ENLARGEMENT, SUTURES AND VITRECTOMY REQUIRED. THE VISION PREOPERATIVE WAS 3/60. THE PATIENT'S POSTOPERATIVE VISION WAS UNKNOWN. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. THERE WAS NO DELAY IN THE PROCEDURE. THE END-USER DID NOT SEEK ANY MEDICAL ATTENTION. MEDICATION WAS PRESCRIBED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21268631 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTER THAT THE NON PRELOADED INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO NEGATIVE DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20780980 ↗
• MalfunctionOct 9, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT ON OPENING THE IOL, IT WAS DISCOVERED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PACKAGED UPSIDE DOWN. THE LENS WAS FLIPPED AND IMPLANTED AS INTENDED. THE LENS STILL REMAINS IN THE PATIENT'S EYE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO DEBILITATING CONDITIONS IN THE PATIENT. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413622 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00 WAS PLANNED TO BE USED BUT HAD TO CHANGE TO A 3-PIECE IOL. IT WAS LEARNED THAT SURGEON IMPLANTED THE SUSPECT IOL ON THE LEFT EYE. HOWEVER, DUE TO A BROKEN CAPSULE FROM PREVIOUS DAMAGE TO THE EYE THE DOCTOR RESULTED IN PERFORMING AN ANTERIOR VITRECTOMY AND SUCCESSFULLY IMPLANTED A 3-PIECE LENS. IT WAS STATED THAT THERE WAS NO PRODUCT QUALITY ISSUE IN THE SUSPECT IOL. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20276684 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE NON PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF DYSPHOTOPSIA, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, SOFTEC HDO IOL. PATIENT SYMPTOMS PERSISTED FOR 4.5 MONTHS. PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED AS PRE-OPERATIVE: 20/50 AND POST-OPERATIVE: 20/25. THE WAS NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO MEDICAL ATTENTION WAS REQUIRED, AND NO PROCEDURAL DELAY. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20178612 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE ARMS OF THE LENS DID NOT INSERT INTO THE EYE PROPERLY. THE IOL WAS FULLY INSERTED AND THEN REMOVED DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAY IN PROCEDURE. THERE WAS NO MEDICAL ATTENTION OR MEDICATION PRESCRIBED OUTSIDE THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19782083 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601674 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) HAD BEEN DAMAGED WHEN NEW SCRUB WAS TRYING TO LOAD IT. PATIENT CONTACT WITH THE PRODUCT WAS UNKNOWN. NO INFORMATION WAS PROVIDED REGARDING REPLACEMENT LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023476 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POSTERIOR CAPSULE RUPTURE WHICH OCCURRED AFTER IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND REPLACED WITH A BACK-UP LENS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17831201 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TECNIS SINGLE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED AS NOTICED LENS TUMBLING/ UNSTABLE AFTER INJECTING IN BAG. THE PRE-OPERATIVE VISION WAS 6/60. LENS INSERTED IN THE PATIENTS RIGHT EYE AND REMOVED DURING SAME PROCEDURE. INCISION WAS ENLARGED AND VITRECTOMY WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT HAD NO ANATOMICAL ABNORMALITIES. CUSTOMER USED HEALON GV PRO WHICH IS LESS VISCOUS, SO IT WOULD COME OUT EASILY FROM BAG WHEN THE IOL WAS INJECTED. THEN WHILE TRYING TO POSITIONING THE IOL IN THE BAG, IT WAS NOTED THAT THE IOL WAS TUMBLING AND WAS NOT STABLE THUS EXPLANTED. LENS WAS FULLY INSERTED AND THEN REMOVED AND REPLACED WITH ANOTHER COMPETITOR 3 PIECE IOL DURING SAME PROCEDURE FOR SULCUS SUPPORT AS NO BACKUP 3 PIECE TECNIS WAS AVAILABLE IN FACILITY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17600474 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER PLACEMENT OF THE ZCB00 MODEL INTRAOCULAR LENS (IOL) AND DURING VISCOELASTIC REMOVAL, A TEAR WAS NOTICED IN THE POSTERIOR CAPSULE. THE INCISION WAS ENLARGED TO REMOVE THE IOL AND A 3-PIECE LENS WAS IMPLANTED. SUTURE WAS USED TO CLOSE THE INCISION. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 16913455 ↗
• MalfunctionApr 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WERE LINES SEEN ON THE INTRAOCULAR LENS (IOL). THE LENS WAS FULLY INSERTED INTO THE PATIENT'S EYE AND THEN REMOVED. THE IOL WAS REPLACED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811988 ↗
• MalfunctionMar 18, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED AND REPLACED FROM THE PATIENT'S LEFT EYE DUE TO SCRATCH ON IOL. BACK-UP IOL USED SAME MODEL AND DIOPTER SIZE. NO OTHER ADVERSE EVENT. NO INJURY TO THE PATIENT, PATIENT DOING GREAT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569650 ↗