TECNIS IOL ZXR00 (REF ZXR00U0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474579170), received between Dec 21, 2016 and Mar 19, 2024 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 33 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT PRESENTED WITH BLURRED VISION, TIRED EYES, DYSPHOTOPSIA, SENSITIVITY TO SUNLIGHT, AND FEELING SHE WAS SEEING THE EDGES OF THE LENSES AND DISTORTED VISION IN (B)(6) 2023 AND REPORTED IT HAS BEEN GOING ON LIKE THIS SINCE THE CATARACT SURGERY IN 2022. THERE ARE NO KNOWN QUALITY ISSUES WITH THE LENS. PATIENT HAD SEEN MULTIPLE DOCTORS AND HAVE ASKED FOR THE LENS TO BE REMOVED. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT COMPLAINTS AND AN ADJUSTABLE LENS WAS IMPLANTED IN ITS PLACE. PATIENT IS DOING BETTER NOW, ALTHOUGH HIS VISION IS STILL SOMEWHAT BLURRED AND THERE IS SIGNIFICANT CORNEAL EDEMA AFTER THE IOL EXCHANGE THAT IS RESOLVING. FOR THE CORNEAL EDEMA, NO INTERVENTION WAS REQUIRED BEYOND THE USUAL EYE DROPS, AND IT LASTED MORE THAN 15 DAYS AFTER THE LENS EXPLANT. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances

  MAUDE report 18937976 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXTENDED RANGE OF VISION NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE LENS WAS REPLACED WITH LENS MODEL ZXR00 19.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18411239 ↗
• InjuryJun 22, 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 FROM THE PATIENT'S LEFT EYE, DUE TO REFRACTIVE ERROR. THE PATIENT EXPERIENCED BLURRED VISION IMMEDIATELY AFTER SURGERY, BUT IMPROVED AFTER THE IOL WAS REPLACED. REPORTED MANIFEST REFRACTION -2.50, AND BEST VISUAL CORRECTED ACUITY (BCVA) 20/20. IT WAS LEARNED THAT SYMPTOMS BEGAN FOUR DAYS POST IMPLANT. THE REPLACEMENT LENS IS ANOTHER JOHNSON AND JOHNSON IOL, BUT DIFFERENT MODEL, DIB00 AND LOWER DIOPTER 23.0. AT EXCHANGE THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. NO PATIENT POST-OP INJURY AND THE PATIENT IS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12046768 ↗
• MalfunctionMar 18, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE LENS WOULD NOT GO IN WOUND. THERE WAS PATIENT CONTACT BUT THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT WAS REPORTED WHEN INSERTING INTO THE EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL. THE DEVICE EVALUATION FOUND THERE WAS HAPTIC AND LENS DAMAGE WITH PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11514974 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT AFTER THE IMPLANTATION OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL) IN HER LEFT (OS) EYE, HER VISION IMPROVED, BUT OVER TIME THIS VISION DECREASED. THE PATIENT EXPERIENCED STARBURSTS WHILE LOOKING AT LIGHTS, IN WHICH THE DOCTOR PERFORMED A PRK (PHOTOREFRACTIVE KERATECTOMY). THE PATIENT IS STILL EXPERIENCING THE STARBURSTS AND CANNOT DRIVE AS A RESULT. ALSO, WHEN TRYING TO READ, IT SEEMS THE LETTERS ARE ALL SMOOSHED TOGETHER, WHICH REQUIRES READING GLASSES. DRY EYE PRESCRIPTION DROPS AND PLUGS, RESTASIS AND XIIDRA WERE PRESCRIBED. LENS REMAINS IMPLANTED UNTIL SHE RECEIVED ADDITIONAL CONSULTATION FROM THE HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT (OS) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE RIGHT (OD) EYE.

  Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 10909361 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINTS OF BLURRY VISION AND REPLACED WITH A DIFFERENT MODEL AND DIOPTER LENS. THERE WAS NO PATIENT INJURY. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. OUTCOME POST-LENS EXCHANGE WAS REPORTED AS: PATIENT WAS 20/40 WITH STROMAL EDEMA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; No Code Available

  MAUDE report 10255793 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL ZXR00 24.0 DIOPTER WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DUE TO PATIENT EXPERIENCING EXCESSIVE GLARE AND HALO AT NIGHT. SYMPTOMS WERE NOTED AT ONE MONTH POST-OP. IT WAS INDICATED AT EXPLANT/EXCHANGE A VITRECTOMY WAS PERFORMED AND A THREE (3) PIECE IOL WAS PLACED IN SULCUS AS THE REPLACEMENT LENS. PATIENT'S OUTCOME AT THE TIME OF DISCHARGE WAS REPORTED TO BE NORMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Vitrectomy

  MAUDE report 9809278 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE, DUE TO UNACCEPTABLE/INTOLERABLE HALOS, GLARE AND DYSPHOTOPSIA. NO OTHER INFORMATION WAS PROVIDED DESPITE DUE DILIGENCE OF FOLLOW-UP.

  Patient problems: Halo; No Code Available

  MAUDE report 9567351 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNHAPPY WHEN IMPLANTED WITH A ZXR00 INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO HALOS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE, NO PATIENT POST-OP INJURY. REPLACEMENT IOL WAS ZCB00 IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9529539 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNHAPPY WHEN IMPLANTED WITH A ZXR00 INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO HALOS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE, NO PATIENT POST-OP INJURY. REPLACEMENT IOL WAS ZCB00 IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9529536 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. THE PATIENT IS UNHAPPY WITH NEAR VISION POST SURGERY AND REFUSES TO UNDERGO FURTHER TREATMENT. THERE MAY HAVE BEEN OTHER OCULAR/NEURO AILMENTS EXIST. REPORTEDLY, THE PATIENT CANNOT READ, CANNOT SEE WELL TO DRIVE, AND HER EYES DO NOT WORK TOGETHER. A SECONDARY SURGICAL PROCEDURE IS NOT SCHEDULED OR FOR CERTAIN PLANNED AT THIS TIME. PRE-OP VISUAL ACUITY: 20/50 WITHOUT CORRECTION, 20/30 WITH CORRECTION POST-OP VISUAL ACUITY WITHOUT CORRECTION: 20/30 DISTANCE, 20/50 INTERMEDIATE, 20/50 NEAR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9314460 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +24.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING BLURRY NEAR VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH SAME MODEL AND HIGHER DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8490197 ↗
• InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +24.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE THE LENS POWER WAS INCORRECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8464210 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING INTRACTABLE GLARE AND HALOS AFTER THE IMPLANTATION OF +24.0 DIOPTER LENS MODEL, ZXR00 IOL (INTRAOCULAR LENS). FOR THAT REASON, LENS WAS EXPLANTED AND REPLACED WITH +23.5 DIOPTER LENS MODEL, ZCB00 23.5 DIOPTER MONOFOCAL IOL. AFTER THE REPLACEMENT, PATIENT HAD NO COMPLAINTS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8446426 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 24.0 DIOPTER INTRAOCULAR LENSES (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018. THE LENS WAS REPLACED WITH ZXR00 23.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8352125 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 24.0 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 INTO THE PATIENT'S RIGHT EYE. THE IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO INTOLERABLE GLARE WHICH WERE FIRST REPORTED ON (B)(6) 2017. IT WAS ALSO REPORTED THERE WAS NO SIGNIFICANT RESIDUAL REFRACTIVE ERROR; NO DRY EYE. THE IOL EXCHANGE WAS PERFORMED WITHOUT COMPLICATION AND THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. THE PATIENT WAS STABLE WHEN DISCHARGED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED BY THE SURGERY CENTRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8300801 ↗
• MalfunctionFeb 4, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHEN INSERTING A ZXR00 24.0 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THE IOL APPEARED TO BE SCRATCHED. REPORTEDLY, THE IOL WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. A ZXR00 23.5 WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR ANY INJURY. THE PATIENT WAS REPORTED DOING FINE POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300778 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +24.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN SECONDARY PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY. AN INTRAOCULAR LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7608746 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +24.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY. AN INTRAOCULAR LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7608737 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE A ZXR00 24.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 FOR UNSPECIFIED REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7589681 ↗
• InjuryApr 14, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +24.0 DIOPTER) WAS EXPLANTED THE PATIENT'S OPERATIVE EYE AND EXCHANGED FOR ANOTHER LENS. REPORTEDLY THERE WAS NO LENS DEFECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7431532 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +24.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING VISUAL DISTURBANCE, HALOS AND GLARES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7388771 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +24.0 DIOPTER) WAS IMPLANTED IN PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER SCHEDULED TO BE EXPLANTED ON (B)(6) 2018 IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION, HALOS, VISUAL DISTURBANCE AND LIGHT SENSITIVITY. REPORTEDLY THE NEAR VISION WAS 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 7364375 ↗
• InjuryFeb 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +24.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF UNSATISFACTORY VISUAL OUTCOME, HAZY VISION, AND DOCTOR'S OBSERVATION OF A DISPLACED HAPTIC. DURING THE EXPLANT PROCEDURE DOCTOR HAD TO PERFORM A VITRECTOMY AND AN NON-AMO INTRAOCULAR LENS WITH +22.0 DIOPTER WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO PATIENT INJURY POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 7248871 ↗
• MalfunctionOct 23, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CRINKLED IN THE PACKAGE. THROUGH FOLLOW UP, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THE OPTIC SURFACE WAS CRINKLED AND THAT THE HAPTIC WAS NOT CRINKLED. IT WAS ALSO CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE. THERE WAS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND NO SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6970646 ↗