TECNIS IOL ZXR00 (REF ZXR00U0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474591707), received between Jan 19, 2018 and May 15, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT "A SMUDGE" WAS FOUND BEHIND THE IMPLANTED LENS IN THE LEFT EYE AND THAT THE SMUDGE WAS GROWING. THE PATIENT WAS TOLD THAT THE LENS CANNOT BE REMOVED SINCE IT WOULD BE DETRIMENTAL TO THE VISION. THE PATIENT ALSO HAS CLOUDY VISION, TROUBLE SEEING AT NIGHT, AND HALOS, WHICH CAUSED THE PATIENT TO STOP DRIVING AT NIGHT. THE PATIENT HAS CONSULTED A SECOND DOCTOR AND REPORTED BEING TOLD THE SAME AS THE ORIGINAL DOCTOR ADVISED. THE PATIENT IS TAKING DROPS FOR VERY DRY EYES (CEQUA) AND OTHER DRY-EYE, OVER-THE-COUNTER DROPS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Flashers; Foreign Body Sensation in Eye; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16936245 ↗
• InjuryNov 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL FAILURE. THE INCISION WAS ENLARGED, AND A SUTURE WAS REQUIRED HOWEVER, NO ADDITIONAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9277070 ↗
• MalfunctionSep 17, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE EYE, WAS OBSERVED NOT UNFOLDING CORRECTLY. THE LENS WAS FULLY INSERTED AND THEN REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MODEL AND DIOPTER. THE PATIENT WAS REPORTED AS FINE, DOING GREAT. THE REMOVED LENS IS NOT RETURNING. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9080117 ↗
• InjuryJun 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A ZXR00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER REMOVED ON (B)(6) 2018 DUE TO UNSPECIFIED LENS MALFUNCTION. THERE WAS NO INCISION ENLARGEMENT OR SUTURE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, PATIENT IS DOING WELL POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8685610 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019 DUE TO HALOS AND GLARE. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8602010 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT EXPLANT WAS PLANNED (REASON NOT PROVIDED) FOR A ZXR00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WHICH WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT IT APPEARS THE SURGEON TRIED TO REPOSITION THE LENS AND IT WAS NOT HELPFUL TO THE PATIENT. THE LENS WAS EXPLANTED AS PLANNED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8138905 ↗
• MalfunctionSep 7, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A ZXR00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO MECHANICAL FAILURE. INCISION WAS ENLARGED, AND SUTURE WAS NOT USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7857487 ↗
• InjuryMay 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (MODEL ZXR00, +13.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE BECAUSE OF THE PATIENT EXPERIENCING RESIDUAL MYOPIA. THE LENS WAS REPLACED WITH MODEL ZXR00, +11.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, AND NO PATIENT INJURY WAS REPORTED. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7517391 ↗
• InjuryFeb 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +13.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S OPERATIVE EYE BECAUSE OF DOCTOR'S DIAGNOSIS, UNSPECIFIED LENS MALFUNCTION. REPORTEDLY MODEL ZXR00 +14.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7301526 ↗
• InjuryJan 19, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT A ZXR00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS FOUND TO BE CRACKED DURING POST OPERATIVE EXAMINATION. IT WAS LATER EXPLANTED DUE TO PATIENT COMPLAINING OF BLURRINESS. PATIENT ALSO COMPLAINED OF PAIN. DURING THE EXPLANT INCISION ENLARGEMENT WAS PERFORMED. THERE WAS NO VITRECTOMY PERFORMED AND THERE WAS NO CAPSULAR BAG TEAR. A NON-AMO IOL WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. FURTHER DETAILS WERE PROVIDED AND REPORTED THAT DURING ONE DAY POST EXAMINATION PATIENT COMPLAINED ABOUT BLURRY VISION AND WAS NOT HAPPY WITH THE LENS. DOCTOR ADDED THAT DURING IMPLANTATION ON (B)(6) 2017, OPTIC APPEARED TO BE FRACTURED AFTER IMPLANTATION. AS THE LENS WAS IN THE EYE, THE DOCTOR DECIDED TO KEEP IT IN AS IT APPEARED TO BE FINE TO HIM AFTER IMPLANTATION. BUT PATIENT CAME BACK THE NEXT DAY AND COMPLAINED ABOUT BLURRY VISION SO HE DECIDED TO EXPLANT. CONTRIBUTING MEDICAL HISTORY NOTED AS PUPIL DILATION. CORNEAL EDEMA AFTER EXPLANT BUT HE IS RECOVERING AND IS GETTING BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; Pain

  MAUDE report 7207948 ↗