TECNIS IOL ZXR00 (REF ZXR00U0125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474591691), received between Dec 12, 2017 and Mar 6, 2023 — classified as 12 injuries, 5 malfunctions.

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

• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT WAS SEEN IN (B)(6) 2022 AND WAS VERY UNHAPPY WITH THE VISION IN THE LEFT EYE. THE PATIENT COMPLAINED OF POOR VISION (20/25), BUT MOSTLY DEBILITATING GLARE. THE PATIENT CONTINUED TO GO BACK TO THE SURGEON OVER A YEAR'S TIME, BEING CONTINUALLY ASSURED THAT THINGS WOULD GET BETTER. THE PATIENT DOES NOT WANT TO RETURN TO THE SURGEON FOR ANY CARE AND DOES NOT WANT TO HAVE THE RIGHT EYE DONE UNTIL THIS IS RESOLVED. THE SURGEON IS CONSIDERING RECOMMENDING REPLACEMENT OF THE IOL WITH A STANDARD MONOFOCAL IOL. PRE-OPERATIVE, THE PATIENT WAS A HIGH MINUS - 10.00 WITH BEST CORRECTED VISUAL ACUITY 20/50. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S SYMPTOMS FIRST STARTED ON (B)(6) 2021. THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PLANNED INTERVENTIONS. THE LENS REMAINS IMPLANTED. THE PATIENT WILL BE HAVING A LIPIFLOW TREATMENT DONE ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16486776 ↗
• MalfunctionOct 31, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10767130 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED BILATERALLY WITH INTRAOCULAR LENSES (IOLS). PATIENT WAS SEEING HALOS AT NIGHT AND BLUE LIGHT APPEARED FUZZY. PATIENT ALSO COMPLAINED OF POOR NEAR VISION. IN THE LEFT EYE DISTANCE VISION WAS REPORTED AS 20/30 AND NEEDS GLASSES TO READ. POSITIVE DYSPHOTOPSIA PRESENT FROM 1-DAY POST-OP. THERE WAS NO REPORT OF SIGNIFICANT INTERFERENCE OF DAILY ACTIVITIES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IOL WAS SUBSEQUENTLY EXPLANTED FROM THE PATIENT'S LEFT EYE. A REPORT IS NOT BEING SUBMITTED FOR THE COMPANION IOL AS IT REMAINS IMPLANTED IN THE PATIENT'S RIGHT EYE, AND THERE IS NO INDICATION OF REQUIRED INTERVENTION OR THE OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE ASSOCIATED WITH THAT LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 10268563 ↗
• MalfunctionApr 24, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998907 ↗
• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648544 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REACHED OUT TO JOHNSON & JOHNSON REQUESTING ASSISTANCE WITH A PATIENT REPORTING DIFFICULTY/COMPLAINING OF ¿DAY TIME GLARE¿ THAT IS RESULTING IN PATIENT SUFFERING WITH DAY TIME DRIVING. A REQUEST AND SUPPORT TO LOOK OVER THE CHARTS IN AN EFFORT TO ASSIST WITH IDENTIFYING CONCERNS AND FINDING A RESOLUTION. FURTHER INFORMATION NOTES PATIENT IS A HIGH MYOPE. PATIENT STATES HE IS NOT HAPPY WITH VISUAL ACUITY (VA) FOR DISTANCE WHEN DRIVING AT NIGHT DUE TO GLARE/HALOS. PATIENT IS NOT HAPPY WITH VA FOR NEAR OR INTERMEDIATE AT ALL. HE IS NOT HAPPY HAVING TO USE READERS EVEN THOUGH HE CAN SEE WITH OTC (OVER THE COUNTER) READERS. PATIENT THOUGHT HE WOULD NOT NEED TO WEAR GLASSES AT ALL. HE STATES HE WAS TOLD HE WOULD HAVE PERFECT VISION FOR NEAR AFTER SURGERY. CONSULTATION WAS PERFORMED AND DISCUSSION IS STILL ONGOING. THE PATIENT COMPLAINS BITTERLY OF GLARE WITH NO OBVIOUS SOURCE AND PATIENT IS RESISTING FURTHER EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL LENS IMPLANTS; THIS REPORT REPRESENTS THE SECOND OF THE TWO LENS IMPLANTS.

  Patient problems: Halo; No Code Available

  MAUDE report 9373436 ↗
• MalfunctionOct 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251925 ↗
• InjuryOct 8, 2019Adverse 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 A POWER MISS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9165053 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT REPORTED OF AN UPCOMING INTRAOCULAR LENS (IOL) EXCHANGE OF A MODEL ZXR00 12.5 DIOPTER DUE TO PATIENT HAVING DIFFICULTY WITH HALOS AND GLARES. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2019 AS IT HAD BEEN SCHEDULED, AND A REPLACEMENT LENS, MODEL ZCT400 12.5 DIOPTER WAS USED. IT WAS INDICATED THAT THE EXPLANTED LENS HAS BEEN RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9137735 ↗
• MalfunctionFeb 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A ZXR00 12.5D INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE FIBER ON THE HAPTIC. THE IOL WAS NOT INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380767 ↗
• InjuryNov 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO A MISCALCULATION ISSUE; THE WRONG SIZE WAS SELECTED. THE LENS WAS EXCHANGED FOR A HIGHER DIOPTER. THE EVENT WAS NOTICED AT THE PATIENT'S FIRST POST OP VISIT. THERE WAS NO OTHER SURGICAL INTERVENTION REQUIRED. PATIENT DOING FINE; THERE WERE NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8071255 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +12.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE. REPORTEDLY, PATIENT WAS EXPERIENCING A HAZY FILM WITH THEIR VISION, LIKE LOOKING THROUGH SOAPY GLASS. DURING THE EXPLANT PROCEDURE AN INCISION ENLARGEMENT WAS PERFORMED; HOWEVER, THERE WAS NO PATIENT INJURY, NO VITRECTOMY AND NO SUTURE. A LENS MODEL AAB00 +12.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT IS DOING GOOD POST-OPERATIVE WITH NO PAIN OR DISCOMFORT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7768870 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING VISUAL ISSUES SINCE (B)(6) 2017. PER ACCOUNT, THE PATIENT HAD PERSISTENT BLUR, STREAKING IMAGE FROM MOVING TENNIS BALL, GLARE FROM OVERHEAD FLUORESCENT LIGHTING WHILE PLAYING TENNIS AT NIGHT, AND LOSS DEPTH OF PERCEPTION. AS A RESULT, ZXR00 INTRAOCULAR LENS (IOL) SN (B)(4) WAS EXPLANTED FROM PATIENT'S LEFT EYE (OS). LENS WAS REPLACED WITH A MODEL PCB00 12.5 DIOPTER. POST-SURGERY, PATIENT IS HAPPY WITH COMPLETE RESOLUTION OF ALL SYMPTOMS AND THERE WAS NO PATIENT INJURY. PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 7543681 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DISSATISFIED WITH THE MODEL ZXR00 INTRAOCULAR LENS ON THE LEFT EYE (OS). THE LENS WAS EXPLANTED. THE LENS WAS REPLACED WITH A MODEL ZCB00 LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535970 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT DID NOT LIKE THE EXTENDED DEPTH OF FOCUS. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZCB00. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7287282 ↗
• InjuryFeb 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO PATIENT COMPLAINTS ABOUT HALOS. THE REPLACEMENT LENS WAS A Z9002 12.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7272140 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT EXPERIENCED SEVERE HALOS AND GLARE, INCLUDING POOR NEAR AND INTERMEDIATE VISION EVEN WHEN CORRECTING FOR RESIDUAL REFRACTIVE ERROR. THESE SYMPTOMS WERE REPORTED AS SIGNIFICANTLY INTERFERING WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT PERFORMED. THE LENS WAS REPLACED WITH A ZCB00 13.5 DIOPTER LENS AND THE SYMPTOMS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 7110976 ↗