TECNIS IOL ZXT225 (REF ZXT225U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605701), received between Jul 14, 2017 and Nov 8, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2023Adverse 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 (IOL) WAS EXPLANTED FROM THE PATIENT LEFT EYE DURING SECONDARY SURGERY DUE TO GLARES AND HALOS. PATIENT TRIED LENS FOR 1.5 YEARS BUT COULD NOT ADJUST. THERE WAS INCISION ENLARGEMENT REQUIRED. THE LENS WAS REPLACED WITH ANOTHER COMPANY IOL. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 18097339 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, BUT SHE CAN¿T SEE UP CLOSE, INTERMEDIATE ITEMS, SEES HALOS AND CAN¿T DRIVE AT NIGHT. IT WAS LEARNED THAT SHE ALSO HAS GLARES. THE PATIENT IS SO UPSET BECAUSE HER VISUAL CONCERNS HAVE BEEN GOING ON SINCE AROUND THE BEGINNING OF IMPLANTING OF THE INTRAOCULAR LENSES (IOLS) UNTIL NOW. THE PATIENT CLAIMS THAT THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE FOUND ANOTHER DOCTOR WHO EXPLANTED HER IOL FROM HER RIGHT EYE (OD). THE DOCTOR WANTS TO WAIT SO SEE HOW THE PATIENT DOES BEFORE POTENTIALLY EXPLANTING THE LENS IN THE OTHER EYE. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OD.

  Patient problems: Halo; No Code Available

  MAUDE report 10202310 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD A ZXT225 INTRAOCULAR LENS (IOL) IMPLANTED IN HIS LEFT (OS) EYE ON (B)(6) 2019. HE IS COMPLAINING OF BLURRY VISION, STARBURST, HALO AND GLARE, AND HAS POOR NEAR VISION. HE IS NOW REQUIRED TO WEAR GLASSES FOR READING. THE DOCTOR PRESCRIBED BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% FOR HIS EYES FOR NOW UNTIL HIS NEXT CONSULTATION VISIT. THE LENS REMAINS IMPLANTED AND NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT IS SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9493843 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BILATERAL LENS IMPLANTS. AN INTRAOCULAR LENS, (IOL) MODEL ZXT225 15.5 DIOPTER WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (B)(6) 2018. PATIENT IS NOT HAPPY WITH THE RESULTS AND HAS REQUESTED AN EXCHANGE OF THE LENS. REPORTEDLY, SHE HAS BEEN EXPERIENCING SPIDER-WEB VISION SINCE SURGERY. SHE STATED THAT SHE FEELS UNCOMFORTABLE DRIVING AT NIGHT. THE SURGEON INDICATED THAT AN EXPLANT HAS BEEN SCHEDULED FOR (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8205233 ↗
• MalfunctionSep 15, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) HAD SHIFTED IN AXIS. DURING FOLLOW UP, IT WAS FOUND THAT THE PATIENT HAD BILATERAL LENS IMPLANTS AND BOTH IOL¿S HAD ROTATED 10 DEGREES EACH. THE DOCTOR IS STILL WAITING FOR THE PATIENT TO GO BACK FOR FOLLOW-UP TO DECIDE ON A PLAN OF ACTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH EYE. THIS REPORT CAPTURES THE INFORMATION FOR THE LEFT EYE.

  Patient problems: No Information

  MAUDE report 6869727 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO RESIDUAL MYOPIA RESULTS. FURTHERMORE, THE PATIENT WAS DISSATISFIED WITH THEIR DISTANCE VISUAL ACUITY. THERE WAS NO PATIENT INJURY REPORTED, NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. THE LENS WAS REPLACED WITH A ZXT300, 14.5, A LOWER DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6715997 ↗