TECNIS IOL ZCB00 (REF ZCB0000150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474531611), received between Oct 5, 2017 and May 15, 2024 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, A CAPSULE TEAR WAS OBSERVED. THE IOL WAS REMOVED AND REPLACED FOR AN AR40 IOL. THE WOUND WAS CLOSED WITH UNPLANNED 10-0 NYLON SUTURES AND THERE WAS NO VITREOUS LOSS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19327220 ↗
• InjuryFeb 23, 2023Contamination; Contamination

  THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: A RARE INTRAOCULAR LENS SURFACE FOREIGN BODY DURING PHACOEMULSIFICATION SURGERY: A CASE REPORT A CASE REPORT WAS DONE TO PRESENT A RARE CASE OF AN INTRAOCULAR LENS (IOL) SURFACE FOREIGN BODY BEING TIGHTLY ATTACHED TO THE IOL POSTERIOR SURFACE DURING SURGERY, WHICH SERIOUSLY INFLUENCED THE PATIENT¿S POSTOPERATIVE VISUAL ACUITY. A 76-YEAR-OLD FEMALE WITH CATARACTS UNDERWENT PHACOEMULSIFICATION SURGERY ON HER RIGHT EYE AND IMPLANTATION OF THE IOL TECNIS (ZCB00; JOHNSON & JOHNSON VISION). DURING SURGERY, ONCE THE OPTIC REGION WAS IMPLANTED IN THE EYE, THE AUTHORS WERE SURPRISED TO OBSERVE A TRIANGULAR TRANSPARENT SEEMINGLY FOREIGN BODY ON THE POSTERIOR SURFACE OF THE IOL. THE PATIENT UNDERWENT A SECOND OPERATION TO REMOVE THE FOREIGN BODY AND IMPROVE THE PATIENT¿S VISUAL ACUITY. THE FOREIGN BODY WAS EVALUATED BY A FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND THE RESULTS OF THIS EVALUATION SHOWED IT WAS A POLYETHYLENE MATERIAL. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: LI C, LU P. A RARE INTRAOCULAR LENS SURFACE FOREIGN BODY DURING PHACOEMULSIFICATION SURGERY: A CASE REPORT. MEDICINE 2021

  Patient problems: Visual Impairment

  MAUDE report 16433554 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE IMPLANTED INTRAOCULAR LENS (IOL) AS PATIENT STATED THAT IT WAS HARD TO READ. THE PATIENT WAS TEMPORARILY IMPAIRED. THE LENS WAS EXPLANTED FROM PATIENT EYE IN A SECONDARY SURGERY PERFORMED A FEW HOURS LATER ON THE SAME DAY IT WAS IMPLANTED. THE REPLACEMENT LENS WAS OF THE SAME MODEL BUT DIFFERENT DIOPTER JOHNSON AND JOHNSON IOL. THE PATIENT WAS DOING WELL AND WENT HOME WITH NO ISSUES. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 12163353 ↗
• InjuryJul 13, 2021Adverse 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 DUE TO POOR REFRACTIVE OUTCOME AND ANISOMETROPIC ISSUES DESCRIBED AS BLURRY VISION, UNABLE TO MAKE THE EYES WORK TOGETHER, THE PATIENT FELT "CRAZY AND DIZZY". DATE OF ONSET OF SYMPTOMS WAS SINCE DAY ONE (1) POST-OP. THE PATIENT WAS NOT HAPPY WITH VISUAL OUTCOME, BUT WAS OK WHEN WEARING PRESCRIPTION GLASSES. THERE WAS NO PATIENT POST-OP INJURY, NO VITRECTOMY, AND NO INCISION ENLARGEMENT. REPLACEMENT LENS WAS A DIFFERENT MODEL, ZA9003 AND HIGHER DIOPTER, 18.5. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12156908 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FULLY INSERTED LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. CUSTOMER REPORTED CAPSULE TEAR/COLLAPSE. REMOVED LENS, REPLACED WITH LENS ZA9003. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12125922 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DECIDED A 3 PIECE LENS AND HENCE, THE INTRAOCULAR LENS WAS REMOVED FROM PATIENT'S EYE AND REPLACED WITH ANOTHER LENS OF DIFFERENT MODEL DURING THE SAME PROCEDURE. NO ISSUE WAS REPORTED AGAINST THE LENS. HOWEVER, A 10-0 NYLON SUTURE WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110305 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE PATIENT EXPERIENCED LIGHT STREAKS, HALOS AND GLARE. A YAG (YTTRIUM-ALUMINUM GARNET) LASER PROCEDURE WAS PERFORMED. THE PATIENT REPORTED LIGHT STREAKS, GLARE AND HALOS ON (B)(6) 2021. HOWEVER, HE SAID HE INITIALLY EXPERIENCED SYMPTOMS ONE DAY POST-OP, (B)(6) 2021. THE STARBURSTS HE REPORTED AROUND ON (B)(6), AFTER THE LASER PROCEDURE. DURING THE IMPLANT SURGERY THERE WERE NO COMPLICATIONS, NO SUTURES REQUIRED, AND NO VITRECTOMY. REPORTEDLY, THERE IS LIKELY NOTHING WRONG WITH THE IOL AND THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Flashers; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12046727 ↗
• InjuryJul 24, 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 LEFT EYE DUE TO BLURRY VISION WITH RESIDUAL HYPEROPIA. AT EXPLANT, THERE WAS INCISION ENLARGEMENT, BUT NO SUTURES OR VITRECTOMY WAS REQUIRED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE A SAME MODEL, BUT HIGHER DIOPTER (17.0) LENS. THERE WAS NO DELAY IN PROCEDURE. PATIENT WAS VERY HAPPY POST-EXCHANGE. VISUAL ACUITY PRE-OPERATIVE: 20/30 -2.0 REFRACTIVE +0.5 AT 110. VISUAL ACUITY POST-OPERATIVE: 20/20. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10323956 ↗
• InjuryJul 7, 2020Contamination; Contamination

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE, SUBSTANCES WERE FOUND ON THE BACKSIDE OF THE LENS SURFACE WHICH COULD NOT BE SUCKED OUT. THIS ISSUE AFFECTED THE PATIENT'S POST OPERATIVE VISION. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. IT WAS NOTED THAT THE PRODUCT AND FOREIGN MATERIAL WERE NOT KEPT BY THE DOCTOR AND WERE DISPOSED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10242429 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCB00 TECNIS 1-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019, DUE TO THERE NOT BEING ENOUGH CORRECTION. THE IOL WAS REPLACED WITH ANOTHER ZCB00 LENS, BUT A HIGHER DIOPTER, 18.5. AN INCISION ENLARGEMENT WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10064267 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 15.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON AN UNKNOWN DATE OF SERVICE. IT WAS LATER EXPLANTED ON (B)(6) 2019 FOR UNKNOWN REASONS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8364631 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT WHEN INSERTING A ZCB00 INTRAOCULAR LENS (IOL), A BROKEN HAPTIC WAS NOTICED AFTER CONTACT WITH THE EYE. THE PROCEDURE WAS COMPLETED WITH A ZA9003 IOL. NO MEDICAL INTERVENTION WAS PERFORMED AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ISSUES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255446 ↗
• MalfunctionNov 15, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A MODEL ZCB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS BENT INSIDE THE PACKAGE. THROUGH FOLLOW UP, CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING LENS WAS DAMAGED WHEN OPENING FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. A BACK UP LENS WAS USED FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8076515 ↗
• MalfunctionOct 19, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A FOREIGN BODY INSIDE THE LENS CASE OF THE ZCB00 INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7983758 ↗
• MalfunctionOct 5, 2017Crack; Crack

  IT WAS REPORTED THAT A CRACK AT THE RIM OF THE INTRAOCULAR LENS (IOL) WAS NOTED AFTER IOL IMPLANTATION. THE CRACK DID NOT INVOLVE THE VISUAL AXIS AND NO LOOSE FRAGMENT WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916250 ↗