TECNIS IOL ZXR00 (REF ZXR00U0115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474591677), received between Mar 31, 2017 and Jun 21, 2019 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 11.5 DIOPTER LENS WILL BE EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO REFRACTIVE MISS OF -2 AND -2.5, THE DIFFERENCE IS BETWEEN AUTO FRACTION AND MANIFEST. THE VARIANCE REMAINS EACH TIME THE DOCTOR CHECKS. PER THE CUSTOMER, IT'S POSSIBLY DUE TO THE MULTIFOCAL NATURE OF THE IOL. THE EXPLANT WAS SCHEDULED FOR (B)(6) 2019, AND WAS CONFIRMED THAT THE EXPLANT DID OCCUR AS PLANNED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8725291 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A ZXR00, 11.5 DIOPTER INTRAOCULAR LENS (IOL) IN ONE EYE AND A ZLB00 IOL IN THE OTHER. IT WAS STATED THAT THE PATIENT IS SPECIFICALLY UNHAPPY WITH READING. BUT SHE SEES FOR DISTANCE. SHE KIND OF READS J2 BUT NOT HAPPY AT ALL. IT WAS LEARNT THAT THE SUSPECT ZXR00 WAS EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE, NO PATIENT POST-OP INJURY. REPLACEMENT LENS WAS A NON J&J LENS. NO OTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS THE SYMFONY LENS IMPLANT.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8533732 ↗
• InjuryJan 5, 2019Adverse 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 IMPLANTED IN THE PATIENT'S LEFT OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, AND REPLACED WITH A ZCB00 IOL DUE TO HALOS AND GLARE. THERE WAS NO SURGICAL INTERVENTION PERFORMED AND NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8220597 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD NOT ENOUGH NEAR VISION AFTER THE IMPLANTATION OF MODEL ZXR00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) IN PATIENT'S RIGHT EYE (OD). AS A RESULT, LENS HAD TO BE EXPLANTED AND REPLACED WITH MODEL ZLB00 LENS. PATIENT OUTCOME IS REPORTEDLY GOOD. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8220051 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 11.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS NOT HAPPY WITH THEIR OUTCOME AFTER SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7972723 ↗
• InjuryJun 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BILATERAL SYMFONY INTRAOCULAR LENS IMPLANTATION. REFRACTION PRE-OP WAS -5.00 + 0.25 X 175 DEGREES OS (LEFT EYE) VISION 20/25 IN AMBIENT LIGHT AND 20/100 IN MEDIUM GLARE CONDITIONS. A ZXR00 LENS +11.5 DIOPTER WAS IMPLANTED OS ON (B)(6) 2017 VISUAL ACUITY OS ON (B)(6) 2017 WAS 2/20. NEAR VISION NOT RECORDED DUE TO DILATED PUPIL. ON (B)(6) 2017: UNCORRECTED DISTANCE VISUAL ACUITY (UDVA) OS WAS 20/25 - NEAR VISION J6. THE NEAR VISION WAS NOT SHARP. CORRECTED VISUAL ACUITY WAS 20/20 - J1 OU (BOTH EYES) WITH -0.75 + 0.50 X 125 OS. EARLY PCO (POSTERIOR CAPSULE OPACIFICATION) WAS NOTED OD > OS. YAG (YTTRIUM ALUMINIUM GARNET) LASER PERFORMED TO IMPROVE VISION. ON (B)(6) 2017 - PATIENT GLARED TO 20/100 BOTH EYES. ON (B)(6) 2017 - PATIENT COMMENTED THAT SHE WAS UNABLE TO READ AND NEEDED READING GLASSES. ON (B)(6) 2017 - UNCORRECTED VISUAL ACUITY OS 20/25 - (VERY BLURRY) DISTANCE AND J6 NEAR. ON (B)(6) 2017 - UNCORRECTED VISUAL ACUITY OS 20/25 - J6 , REFRACTION OS -0.50 + 0.50 X 135 - 20/20 - J4. ON (B)(6) 2017 LASIK (LASER ASSISTED IN-SITU KERATOMILEUSIS) PERFORMED TO CORRECT SMALL REFRACTIVE ERROR. ON (B)(6) 2017 UNCORRECTED VISUAL ACUITY OS 20/40 , EPI

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

  MAUDE report 7653694 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINT OF DAY AND NIGHTTIME STARBURSTS AND HALOS, WHICH HAS MADE IT DANGEROUS TO DRIVE. THE PATIENT ALSO COMPLAINT OF GLARE, ESPECIALLY WHEN DRIVING. REPORTEDLY, THE PATIENT HAS TO WEAR CHEATERS TO PERFORM UP-CLOSE WORK AND STATES HE HAS DRY EYE, BUT IS TAKING OVER THE COUNTER MEDICATION FOR THIS. THE PATIENT ALSO HAD A LASIK CONSULTATION, WHICH HE WAS ADVISED WOULD NOT HELP WITH THE CURRENT ISSUE. THE PATIENT WILL BE MEETING WITH THE SURGEON ON (B)(6) 2018 TO DISCUSS OPTIONS OF HAVING THE LENS EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT''S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7338610 ↗
• MalfunctionMar 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, THE SURGEON NOTICED A BLACK SPOT ON THE HAPTIC OF AN INTRAOCULAR LENS (IOL). NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6450505 ↗