TECNIS IOL ZXR00 (REF ZXR00U0260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474579217), received between Jan 26, 2017 and Jun 10, 2020 — classified as 11 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SIGNIFICANT MALFORMATION OF ZONULES AND THE ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS CUT OUT OF THE EYE AND THERE WAS DAMAGE TO THE EYE. ADDITIONAL DETAILS FROM FOLLOW UP STATES THAT MALFORMATION OF THE ZONULES WAS A PRE-EXISTING CONDITION OF THE PATIENT WHICH WASN'T CAUSED BY THE LENS. DAMAGE TO THE EYE WAS CAPSULE TEAR AND ANTERIOR VITRECTOMY WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING SECONDARY IOL. PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10140326 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING MYOPIC OUTCOME WITH DISTANCE VISION AGGRESSIVELY WORSE SINCE CATARACT SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. POST OP 6 DAYS: 20/30. POST OP 1 AND HALF WEEK: 20/50 (-100 20/20). 2-WEEK POST OP 20/50 (-100 -20/20). 3 AND HALF WEEK POST OP: 20/50 (-125 - 20/20). VISUAL ACUITY PRE-OP: 20/50 WITH +350. VISUAL ACUITY POST- OP: 20/50 WITH -125 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8964298 ↗
• InjuryAug 30, 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 2018. THE PATIENT DEVELOPED VISUAL COMPLAINTS OF RINGS WITH INABILITY TO DRIVE AT NIGHT. VARIOUS GLASSES/CONTACT LENSES WERE TRIED TO RESOLVE THE ISSUE WITHOUT SUCCESS. AN EXPLANT OF THE MULTIFOCAL LENS IS PLANNED, THE REPLACEMENT LENS WILL BE A MONOFOCAL LENS. DESPITE FOLLOW-UP ATTEMPTS NO OTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8952818 ↗
• InjuryAug 30, 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 EXPLANTED DUE TO VISION ALWAYS FLUTTERY CAUSING DIZZINESS. FOLLOW-UP CONFIRMED THAT THE REPLACEMENT LENS WAS AN AR40E, 24.5 DIOPTER POWER IOL. THE PATIENT¿S VISUAL ACUITY ON POST-OP DAY ONE WAS 20/30. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Dizziness; No Code Available; Visual Disturbances

  MAUDE report 8952792 ↗
• InjuryOct 24, 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, +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT 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. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8002986 ↗
• InjuryOct 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 26.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF HALOS AND GLARES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7963866 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE PATIENT WAS UNHAPPY WITH GLARES AND HALOS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7779690 ↗
• InjuryJul 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE. A MODEL ZXR00 +23.0 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7709003 ↗
• InjuryJun 15, 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 RIGHT EYE (OD) AND REPLACED WITH A MODEL PCB00 IOL. THE REASON FOR EXPLANT WAS NOT PROVIDED. THE EXPLANTED LENS IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7604373 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S OPERATIVE EYE. THE LENS WAS REPLACED WITH A MODEL ZCT150 26.5 DIOPTER IOL. THE REASON FOR THE EXCHANGE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6695694 ↗
• InjuryJan 26, 2017Adverse 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 A FEMALE PATIENT'S LEFT EYE DUE TO VISUAL DISTURBANCE, INADEQUATE AND BLURRY VISION AT NEAR. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE LENS WAS REPLACED WITH A ZMB00 26.5 DIOPTER IOL. THE PATIENT HAS NOW RECOVERED.

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

  MAUDE report 6278290 ↗