TECNIS IOL ZXR00 (REF ZXR00U0110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474591660), received between Aug 4, 2017 and Feb 4, 2020 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2020Adverse 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 11.0 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE (OD) DUE TO MISSED REFRACTION. A REPLACEMENT LENS, MODEL ZLB00 12.5 DIOPTER WAS USED. THERE WAS NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD AND NO INJURY WAS REPORTED. IT WAS NOTED THAT THE LENS IS NOT AVAILABLE AS IT WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9667684 ↗
• InjuryDec 10, 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 +11.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT NOT HAPPY, EXPERIENCING HALOS AND GLARES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9442973 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 11.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017, INTO THE PATIENT¿S LEFT EYE (OS). IT WAS LATER EXPLANTED ON (B)(6) 2018, AND REPLACED WITH A ZCB00 11.5 DIOPTER, DUE TO VISUAL DISTURBANCE (PERSISTENT CONCENTRIC RINGS). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE ACCOUNT COMMENTED THAT THE LENS WAS REPOSITIONED. THE EXPLANTED LENS WILL NOT BE RETURNED FOR EVALUATION. REPORTEDLY, THE PATIENT IS OK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7891938 ↗
• InjuryAug 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT, WHO RECENTLY HAD CATARACT SURGERY ON HER BOTH EYES (OU), DEVELOPED A HYPEROPIC SURPRISE OR UNEXPECTED POST-OP REFRACTION AFTER IMPLANTING ZXR00 MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER RIGHT EYE (OD). MOREOVER, PATIENT WAS SEEING GLARE AND SHE REPORTEDLY SAW RINGS IN THE CENTER OF THE OPTIC IN CERTAIN LIGHT AS SHE DID NOT HAVE ABILITY TO READ. THE DOCTOR, HOWEVER, ADVISED THE PATIENT THAT THESE VISUAL SYMPTOMS SHOULD DISSIPATE AS TIME GOES ON. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7821101 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +11.0 DIOPTER) WAS SCHEDULED TO BE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY AND NO SURGICAL OR MEDICAL INTERVENTION. A NON JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT FOR THE PATIENT. PATIENT WAS HAVING BLURRY VISION AT DISCHARGE WITH THE REPLACEMENT LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7693932 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 11.0 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 EXPERIENCING VISUAL DISTURBANCE, WHICH DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS A ZMA00 10.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7301816 ↗
• MalfunctionSep 29, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT APPEARED TO HAVE A MARK OR A SCRATCH. THE IOL WAS CUT IN PIECES TO REMOVE IT FROM THE EYE, AND A NEW IOL (SAME MODEL AND DIOPTER SIZE) WAS IMPLANTED. THE PATIENT IS FINE. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906498 ↗
• InjuryAug 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00 11.0 DIOPTER, WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A MYOPIC OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6806228 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 11.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE REPLACEMENT LENS IS THE SAME MODEL LENS WITH A HIGHER DIOPTER SIZE (12.5). PER THE REPORTING CLINIC THE REASON FOR THE UNEXPECTED POST-OP REFRACTION IS UNKNOWN AS MEASUREMENTS WERE NOT ORIGINALLY OBTAINED BY THEIR CLINIC. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6766236 ↗