TECNIS IOL ZXR00 (REF ZXR00U0275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474579248), received between Feb 3, 2017 and Mar 27, 2020 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 IOL 27.5 DIOPTER WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT IS EXPERIENCING TOO MUCH GLARE IN BOTH EYES AND WANTS THE LENS EXPLANTED AND REPLACED WITH A STANDARD LENS. NO FURTHER INFORMATION WAS PROVIDED. THE RIGHT EYE IS CAPTURED IN A SEPARATE MEDWATCH REPORT.

  Patient problems: No Code Available

  MAUDE report 9891662 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 27.5 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE DOCTOR PLANS ON PERFORMING IOL EXPLANT IN THE COMING WEEKS DUE TO COMPLAINT OF REFRACTIVE SURPRISE OF -1.25. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8950009 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS IMPLANTED IN THEIR OPERATIVE EYE ON (B)(6) 2019. IMMEDIATELY DURING THE POST-OPERATIVE PERIOD, AN EXPLANT WAS PLANNED FOR (B)(6) 2019 BECAUSE OF PATIENT EXPERIENCING SIGNIFICANT MYOPIA. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THERE WAS SOME INACCURATE CALCULATION ISSUES PRE-OP, HOWEVER IN A LATER FOLLOW-UP, FURTHER CLARIFICATION WAS NOT PROVIDED AS TO WHETHER THE DOCTOR, STAFF OR IOL MASTER GAVE INACCURATE INFORMATION. ALL THAT THE CONTACT WAS TOLD WAS THAT THE LENS WAS NOT AT FAULT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8923018 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE WAS THE WRONG POWER. AN EXPLANT IS PLANNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8507432 ↗
• InjuryOct 24, 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, +27.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF THE PATIENT EXPERIENCING PERSISTENT POST-OP GLARE AND HALOS. THE REPLACEMENT LENS WAS A MONOFOCAL, MODEL PCB00. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8002962 ↗
• InjuryJan 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZXR00 27.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE LENS DISLOCATED. THE LENS WAS REPLACED WITH ANOTHER ZXR00 MODEL LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7204494 ↗
• MalfunctionFeb 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIALLY, IT WAS REPORTED THAT THE PATIENT WAS NOT HAPPY WITH DISTANT VISION. AFTER THE IMPLANTATION OF THE SYMFONY LENSES, PATIENT EXPERIENCED HALOS AND STARBURST ON THE SIDES, IN ALL LIGHTS. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN IS EVALUATING PATIENT SYMPTOMS AND HOPES THAT THE SOLUTION WILL SIMPLY BE A LASIK TOUCH UP FOR THE MINOR REFRACTIVE ERROR ON BOTH EYES. FURTHER INFORMATION REPORTED THAT NO EXPLANT AT THIS TIME, PATIENT IS WEARING CORRECTIVE LENSES FOR FINE TUNING DISTANCE VISION. HOWEVER, PATIENT WILL PROBABLY NEED LASIK TOUCH UP. THE PHYSICIAN REPORTED THAT PATIENT WAS AT 3 WEEKS POST OP ON (B)(6) 2016, AND FEELS BETTER WITH DARKER GLASSES. PATIENT DOES NOT HAVE ANY CORNEAL CHANGES OR DRY EYES. PATIENT HAS -0.75 DIOPTER OF RESIDUAL ASTIGMATISM IN BOTH EYES. FURTHERMORE, THE PHYSICIAN INDICATED THAT THE LENS HAS A CLOUDY CENTRAL AREA. DOCTOR WAS QUESTIONING IF THE LATHE LINES THAT HE SAW AT THE CENTRAL, 0.75MM OF THE SYMFONY LENS COULD CAUSE MYOPIA. REPORTEDLY, AT THIS TIME, PATIENT DID NOT WANT ANY INTERVENTION PERFORMED AND IS CONTENT WITH WEARING GLASSES. THIS REPORT WILL CAPTURE ZXR00 LENS IMPLANTED ON THE LEFT EYE. A SEPARATE MDR REPORT WILL BE FILED

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6302655 ↗