TECNIS IOL ZXR00 (REF ZXR00U0145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474591738), received between Dec 11, 2016 and Dec 28, 2023 — classified as 15 injuries, 2 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. How this data works · Data updated Oct 13, 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.

• 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 RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH LENS OF THE SAME MODEL ZXR00 16.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18411307 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15307771 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THE HAPTIC NOTICED TO BE BENT DURING INTRAOCULAR LENS (IOL) DEPLOYMENT; THERE WAS PATIENT CONTACT, BUT NO INJURY OR ADVERSE EVENTS. ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IT WAS ALSO REPORTED THAT IT WAS POSSIBLE THE EVENT MAY HAVE BEEN RELATED TO USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599070 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A SYMFONY LENS IMPLANTED IN THE LEFT EYE (OS). THE PATIENT HAS NOT BEEN THRILLED WITH BOTH DISTANCE AND NEAR VISION WITH THE SYMFONY IOL. HER DISTANCE VISUAL ACUITY (DVA) POSTOP WAS RIGHT EYE (OD) 20/30- AND OS 20/60-, NEAR OD J6 AND OS J5. IT WAS LEARNED THAT THE POORER VISION IN THE OS IS PARTLY DUE TO THE FACT THAT THE PATIENT¿S CORNEAL ASTIGMATISM LEVEL INCREASED SOMEWHAT AFTER SURGERY. ALTHOUGH VISION IN BOTH EYES IS LESS THAN SATISFACTORY, THE CUSTOMER DECIDED TO EXCHANGE JUST THE OS IOL FIRST AND SEE HOW THE PATIENT DOES. PATIENT HAS DECIDED NOT TO GO WITH ANOTHER TECNIS IOL FOR THE EXCHANGE OS. THE LENS EXCHANGE WAS SUCCESSFUL WITHOUT ANY COMPLICATION AND THE SUSPECT LENS REPLACEMENT WAS NON-JOHNSON AND JOHNSON IOL. THE INCISION WAS NOT ENLARGED, NO SUTURES, NO PATIENT INJURY POST-OP. THE PHYSICIAN ALSO NOTED THE PATIENT'S PUPIL SIZE IS 3-3.5MM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10045562 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A SPIDER WEB VISION IN THE RIGHT EYE WHEN DRIVING AT NIGHT. THEREFORE, THE PATIENT HAS STOPPED DRIVING AT NIGHT. THE PATIENT'S OVERALL VISION IS GOOD AND SHE CAN READ WITHOUT GLASSES. AT THIS TIME, THE LENS REMAINS IMPLANTED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 9115155 ↗
• InjuryAug 20, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXCHANGED FROM A SYMFONY IOL FOR A Z9002 DUE TO SUBLUXATION BECAUSE OF SMALL PERIPHERAL HOLE IN POSTERIOR CAPSULE WITHOUT VITREOUS LOSS WITHIN DAYS OF IMPLANTATION. THE NEW IOL IS CENTERED AND THE PATIENT IS DOING WELL. DOCTOR STATED HE DOES NOT BELIEVE THIS AN IOL COMPLIANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 8910204 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) MODEL ZXR00 14.5 DIOPTER WAS EXPLANTED. THE PATIENT REQUESTED THE EXPLANT DUE TO EXPERIENCING STARBURSTS, HALOS AND STARS, POST OPERATIVELY. VIA FOLLOW-UP THE CUSTOMER CONFIRMED THERE WERE NO OTHER COMPLICATIONS AND THE IOL WAS REPLACED WITH A MODEL ZCT150 15.0 DIOPTER LENS. IT WAS NOTED THE EXPLANTED LENS WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8458862 ↗
• InjuryDec 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 14.5 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 THE PATIENT BEING HYPEROPIC AND WANTING BETTER NEAR VISION. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER ZXR00 BUT A HIGHER DIOPTER (15.5). THERE WAS NO INJURY TO THE PATIENT OR OTHER SURGICAL INTERVENTION REPORTED. THE PATIENT IS DOING WELL POST EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8205738 ↗
• MalfunctionDec 28, 2018Break; Difficult or Delayed Positioning; Device Dislodged or Dislocated; Break; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) DIDN'T ADVANCE SMOOTHLY, SO IT HAD TO BE RELOADED. IT WAS THEN IMPLANTED INTO THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018, BUT THE HAPTIC WAS NOTED KINKED AFTER BEING PLACED IN THE PATIENT'S CAPSULAR BAG, BUT WASN'T DISLOCATED, IT STAYED CENTERED AFTER VISCO REMOVAL. HOWEVER, POST-OPERATIVELY ON (B)(6) 2018, THE LENS WAS OFF CENTER QUITE A BIT. REPORTEDLY, THE PATIENT WILL THINK ABOUT WHAT TO DO AND THERE MAY BE AN EXCHANGE OF THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201904 ↗
• InjuryMay 24, 2018Adverse 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 EYE DUE TO AN INCORRECT LENS POWER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7539690 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A MECHANICAL FAILURE. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7372581 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO POOR QUALITY OF VISION AT NEAR AND DISTANCE VISION. REPORTEDLY, THE LENS POSITIONING ENDED UP MYOPIC AT -.75 NO INCISION ENLARGEMENT WAS PERFORMED. THE REPLACEMENT LENS WAS A NON-AMO LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7145924 ↗
• InjuryOct 23, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6970657 ↗
• InjurySep 11, 2017Adverse 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 IN A SECONDARY SURGICAL PROCEDURE FROM THE EYE OF A (B)(6) FEMALE PATIENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6856681 ↗
• InjuryJun 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZXR00 WAS EXPLANTED FROM A PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6635571 ↗
• InjuryMay 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) INTO A FEMALE PATIENT'S LEFT EYE THE PATIENT HAD BEEN EXPERIENCING HALOS AND GLARE. ADDITIONALLY, THE PATIENT CAN NOT DRIVE AT NIGHT AND CANNOT WALK AROUND THE BACK OF HER HOUSE. PATIENT ALSO STATED THAT SHE HAS TO STAY IN THE DARK AND HAS TO USE CATARACT GLASSES TO GO OUTSIDE. SHE HAS BEEN TO MANY OTHER SPECIALISTS FOR SECOND OPINION AND SHE CLAIMS THAT THEY ALL SAID THAT THE IOL HAS TO BE REMOVED. BUT SHE'S STILL THINKING ABOUT IT BECAUSE IT'S HER EYE AND SYMPTOMS MIGHT GET WORSE IF SHE HAS ANOTHER SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6570765 ↗
• InjuryDec 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE LENS WAS REPLACED WITH A NON-AMO IOL. FURTHERMORE, THERE WAS NO POST-OP PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6165565 ↗