TECNIS IOL ZXT375 (REF ZXT375U280)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 28.0D CYL3.75 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474607132), received between Mar 5, 2019 and Oct 24, 2019 — classified as 1 injury, 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- Blurred Vision1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ROTATED 10 DEGREES, THEREFORE, THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING MUCH BETTER POST REPOSITION AND IS HAPPY NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9233929 ↗InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT375 MULTIFOCAL INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. THE PATIENT REPORTED POST-OPERATIVELY EXPERIENCING BLURRY VISION AT APPROXIMATELY THREE FEET AND ON. VIA FOLLOW-UP THE PATIENT CONFIRMED SHE IS STILL EXPERIENCING BLURRY VISION. REPORTEDLY THE DOCTOR SAID HER EYES ARE NOT NORMAL AND SHE WILL NEED A DIFFERENT DIOPTER. HER EXPLANT DATE IS SCHEDULED FOR (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 8393026 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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