TECNIS IOL ZXT225 (REF ZXT225U110)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 11.0D CYL2.25 · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474605619), received between Mar 24, 2017 and Mar 16, 2019 — classified as 3 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Code Available3
- Halo1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL ZXR00. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8427191 ↗InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT225 11.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED HALOS AND GLARE. THERE WAS AN INCISION ENLARGEMENT MADE, BUT NO VITRECTOMY OR SUTURES USED. THE REPLACEMENT LENS WAS A ZCT225 12.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. PRODUCT IS NOT BEING RETURNED.
Patient problems: Halo; No Code Available
MAUDE report 8027234 ↗InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS HIGH MYOPIC LASIK (-12) AND HAD ENHANCEMENT LASIK AS WELL. FOLLOWING IMPLANT OF THE INTRAOCULAR LENS (IOL), THE PATIENT ENDED UP +3.5 POST-OP AND OBVIOUSLY UNHAPPY. IOL EXCHANGE RESULTED IN EXCELLENT POST-OP VISION AND PATIENT IS HAPPY WITH OUTCOME. THERE WAS NO PATIENT ANATOMY OR PRODUCT QUALITY ISSUES.
Patient problems: No Code Available
MAUDE report 6430692 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.