TECNIS IOL ZCB00 (REF ZCB0000145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474531604), received between Jan 26, 2017 and Oct 6, 2023 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT AFTER IOL WAS IMPLANTED INTO PATIENT EYE, SURGEON NOTICED SOME CRACKS ON THE OPTIC OF THE IOL. THE SURGEON DECIDED NOT TO REMOVE THE IOL AS IT DOES NOT SEEM TO AFFECT THE RESULT OF VISION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887709 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HOLE DEVELOPED IN THE CAPSULAR BAG OF THE RIGHT EYE, POST INTRAOCULAR LENS (IOL) PLACEMENT. THE BAG COULD NOT SUPPORT THAT IOL AND THE IOL WOULD NOT STAY IN PLACE. THE IOL WAS REMOVED AND VITRECTOMY WAS PERFORMED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, AR40E) DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO ISSUE NOTED WITH THE LENS. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16686816 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REFRACTIVE SURPRISE NEAR A -2.0D WITH AN INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP, IT WAS CONFIRMED THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10549127 ↗
• MalfunctionAug 31, 2020Failure to Fold; Failure to Unfold or Unwrap; Failure to Fold; Failure to Unfold or Unwrap

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAD FOLDING/UNFOLDING ISSUES AND THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10474535 ↗
• InjuryAug 4, 2020Material Opacification; Material Opacification

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT A CORNEAL TRANSPLANT ON (B)(6) 2008 AND INTRAOCULAR LENS (IOL) IMPLANTATION ON (B)(6) 2009 IN THE RIGHT EYE NOW HAS FAIRLY SIGNIFICANT OPACIFICATION OF THE POSTERIOR CAPSULE, AND THE IOL IS FOGGY OR SOMEWHAT OPACIFIED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT EXPERIENCED SOME BLUR, GLARE, AND LOSS OF FIVE LINES BEST CORRECTED VISUAL ACUITY (BCVA). SYMPTOMS SIGNIFICANTLY INTERFERE WITH NORMAL DAILY ACTIVITIES. SURGEON IS HESITANT TO PERFORM YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE AS IT WOULD COMPLICATE POTENTIAL IOL EXCHANGE. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10360469 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE LENS INTO THE EYE A TORN HAPTIC WAS OBSERVED. THE LENS WAS FULLY INSERTED INTO THE EYE, WAS CUT OUT AND DISCARDED IN SAME SURGICAL PROCEDURE. VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. POST-OP DAY ONE THE LENS WAS REPORTEDLY IN GOOD POSITION AND PATIENT IS FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9795972 ↗
• MalfunctionAug 30, 2019Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS IDENTIFIED WITH FOREIGN MATTER AND COSMETIC ISSUES. THE FOREIGN MATTER WAS IDENTIFIED AS SOON AS THE NURSE OPENED THE LENS CASE. IT APPEARED TO BE A SPOT OR DOT IN THE CENTER OF THE IOL. THE IOL WAS NOT PREPARED FOR SURGERY, NO HEALON WAS INTRODUCED TO THE IOL AND NO MANIPULATION WAS NOTICED. THE PRODUCT IS AVAILABLE FOR EVALUATION AND THE HOSPITAL WILL BE SENDING THEM TO SANTA ANA AS PART OF THE NORMAL COMPLAINT PROCESS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8952791 ↗
• MalfunctionAug 30, 2019Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS IDENTIFIED WITH FOREIGN MATTER AND COSMETIC ISSUES. THE FOREIGN MATTER WAS IDENTIFIED AS SOON AS THE NURSE OPENED THE LENS CASE. IT APPEARED TO BE A SPOT OR DOT IN THE CENTER OF THE IOL. THE IOL WAS NOT PREPARED FOR SURGERY, NO HEALON WAS INTRODUCED TO THE IOL AND NO MANIPULATION WAS NOTICED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8948517 ↗
• InjuryDec 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THE ZCB00 +14.5 INTRAOCULAR LENS (IOL) IMPLANTED ON (B)(6) 2017 IN THE RIGHT EYE (OD) AND DEVELOPED ANISOMETROPIA. VISUAL DISTURBANCE AND UNEXPECTED POST-OP REFRACTION WERE ALSO REPORTED. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND A ZCB00 +17.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE ANISOMETROPIA OCCURRED BECAUSE THE LENS TILTED. THERE WAS NO PATIENT INJURY, NO VITRECTOMY AND NO INCISION ENLARGEMENT REQUIRED. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8137279 ↗
• InjuryOct 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCB00 14.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2015. IT WAS LATER EXPLANTED AROUND (B)(6) 2015 BECAUSE THE PATIENT COULD NOT SEE. THE REPLACEMENT LENS WAS A ZCB00 16.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7987801 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCB00 +14.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE, ACCORDING TO THE DOCTOR, THE WRONG LENS WAS IMPLANTED. THE REPLACEMENT LENS WAS A ZXR00 +14.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7501696 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 14.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO THE PATIENT HAVING TROUBLE SEEING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7493265 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018 AND SINCE THE PATIENT HAD TROUBLE SEEING AND BLURRY VISION, THE LENS WAS EXPLANTED ON (B)(6) 2018. THERE WAS AN INCISION ENLARGEMENT AND SUTURE WAS USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER (17.5). THERE WERE NO OTHER MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT WAS FINE AT THE TIME OF DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7491937 ↗
• MalfunctionApr 11, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE SPOTS WERE OBSERVED ON A ZCB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) DURING HANDLING AND PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. ANOTHER LENS WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7424150 ↗
• MalfunctionMar 31, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A DEBRIS WAS NOTICED ON THE OPTIC OF AN INTRAOCULAR LENS (IOL) WHEN IT WAS OPENED TO LOAD IT INTO THE CARTRIDGE. REPORTEDLY, THE LENS WAS NOT USED AND IT WAS DECIDED TO USE ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6448754 ↗
• MalfunctionMar 29, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT WHEN AN INTRAOCULAR LENS (IOL) WAS INJECTED INTO THE PATIENT'S EYE, IT CAME OUT IN PIECES. REPORTEDLY, THE LENS TORE SOMEHOW GOING THROUGH THE CARTRIDGE, DUE TO A POSSIBLE ISSUE WITH THE CARTRIDGE. PATIENT CONTACT WITH THE LENS WAS REPORTED. ANOTHER LENS, SAME MODEL AND DIOPTER, WAS USED. THERE WAS NO SECONDARY SURGICAL PROCEDURE, NO INCISION ENLARGEMENT, NO SUTURE WAS USED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6443324 ↗
• InjuryJan 26, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PHYSICIAN IMPLANTED A ZCB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) ON A PATIENT'S RIGHT EYE. HOWEVER, THE PHYSICIAN WAS AIMING FOR PLANO THUS REQUIRING A LENS EXCHANGE FOR ZCB00 10.5 DIOPTER IOL. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT¿S SYMPTOMS SIGNIFICANTLY AFFECTS HIS DAILY ACTIVITIES. PRIOR TO EXPLANT THE LENS HAD ROTATED 20 DEGREES COUNTERCLOCKWISE. LENS WAS REPLACED WITH A ZCB00 10.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. PATIENT PRESCRIBED BESIVANCE 1DROP 3X/DAY FOR 1 WEEK, LOTEMAX GEL 1 DROP 3X/DAY FOR 4 WEEKS, PROLENSA 1 DROP 1X/DAY FOR 4 WEEKS. PATIENT IS DOING GOOD AFTER THE REPLACEMENT. PATIENT'S VISUAL ACUITY: VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/60-2. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/400. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/30-. IT WAS INDICATED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURNED PRODUCT EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6281552 ↗