TECNIS IOL ZXR00 (REF ZXR00U0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474591721), received between Oct 27, 2016 and Sep 25, 2019 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Kinked” (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. How this data works · Data updated Oct 13, 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.

• 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 LEFT 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 LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 9115145 ↗
• InjurySep 9, 2019Adverse 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 DUE TO PATIENT DISSATISFACTION AND REPORTEDLY NOT BEING ABLE TO SEE. PATIENT WAS UNHAPPY WITH VISION STRAIN, HEADACHES, AND IMBALANCE. ALSO NOTED SHE COULD SEE THE OUTLINE OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Headache; No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8974476 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLURRED VISION. THE PATIENT'S ASTIGMATISM CONTINUED TO PROGRESS AFTER IMPLANTATION. VISUAL ACUITY PRE-OPERATIVE AND POST-OP WAS 20/60. THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE LENS WAS DISCARDED. AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. LENS WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER AS A REPLACEMENT. REPORTEDLY, THE PATIENT'S UNCORRECTED VISUAL ACUITY IS 20/100 WITH EDEMA AS THE PATIENT HAS NOT HEALED YET. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8928549 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT OF THE INTRAOCULAR LENS (IOL) WAS PERFORMED. PATIENT REPORTEDLY WAS SUFFERING FROM AMETROPIA, REFRACTIVE SURPRISE, AND BLURRED VISION. THERE WAS AN INCISION ENLARGEMENT, ONE SUTURE AND NO VITRECTOMY. VISUAL ACUITY PRE-OP: 20/25 GLARE 20/400. VISUAL ACUITY POST-OP: 20/25. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8580349 ↗
• InjuryMar 11, 2019Adverse 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 ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED REVEALED THE IOL TO BE A ZXR00 14.0D WHICH WAS IMPLANTED ON (B)(6) 2018. THERE WERE NO ISSUES REPORTED WITH THE SURGERY; NO WOUND ENLARGEMENT OR VITRECTOMY. THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF GHOSTING, STARBURSTS AND HALO'S AROUND LIGHTS AND TROUBLE DRIVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8410164 ↗
• MalfunctionFeb 7, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AT THE TIME OF IMPLANTATION OF A ZXR00 14.0 INTRAOCULAR LENS (IOL), THERE WAS A SMALL CHIP IN THE CENTRAL OPTICAL PORTION OF THE IOL. THE SURGEON DETERMINED IT WAS NOT BIOLOGICAL MATTER AND REMOVED THE IOL DUE TO THE LOCATION OF THE CHIP. ADDITIONAL INFORMATION RECEIVED CLARIFIED THE CHIP REFERRED TO A CRACK ON THE IOL. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. A NEW LENS WAS IMPLANTED WITH NO ISSUES AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313927 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 14.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. THE REPLACEMENT LENS WAS A ZCB00 13.0 DIOPTER LENS AND THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7833722 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE POST OP VISIT ON (B)(6) 2017, THAT THE PATIENT COMPLAINED OF BLURRY VISION, GLARE, VISUAL DISTURBANCE WITH A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +14.0 DIOPTER). THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND A NON-AMO INTRAOCULAR LENS WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT REPORTED DOING GREAT POST OP. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7187100 ↗
• InjuryNov 30, 2016Unintended Movement; Unintended Movement

  INITIALLY, IT WAS REPORTED THAT THE PATIENT LANDED -1.50 WEEK ONE WITH A ZXR00 SYMFONY LENS. THE TARGET WAS -.11. A FOLLOW UP INFORMATION REVEALED THAT THE LENS HAD BEEN DISPLACED AND IT WAS ALMOST IN THE SULCUS. THE DOCTOR PLANS TO REPOSITION THE LENS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6134103 ↗
• MalfunctionOct 27, 2016Kinked; Kinked

  IT WAS REPORTED THAT A KINKED OPTIC WAS FOUND PRIOR TO HANDLING THE LENS. THE OPTIC CAME KINKED IN THE CASE; WAS KINKED PRIOR TO HANDLING. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6062545 ↗