TECNIS IOL ZXT150 (REF ZXT150U085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 08.5D CYL1.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604971), received between Jan 19, 2018 and Aug 23, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Off-Label Use” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2021Adverse 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. THE SUSPECT PRODUCT WILL NOT BE RETURNED. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT, NO PATIENT POST-OP INJURY, NO UNPLANNED VITRECTOMY AND ADDITIONAL SUTURES THAT OCCURRED. CURRENTLY PATIENT HAS RECOVERED PERFECTLY WITH NO ADDITIONAL CONCERNS NOR HAS HE RETURNED FOR ANOTHER PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12356134 ↗InjuryJan 19, 2018Off-Label Use; Off-Label Use
IT WAS REPORTED THAT A ZXT150 8.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) OF THE PATIENT. DOCTOR REALIZED THAT THE WRONG LENS FOR THE PATIENT WAS IMPLANTED. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH A MODEL ZCT LENS. THERE WAS AN INCISION ENLARGEMENT, AND SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE POST-OPERATIVELY. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 7207509 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page