TECNIS IOL ZXT375 (REF ZXT375U220)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 22.0D CYL3.75 · 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 05050474607019), received between Jul 17, 2017 and Aug 13, 2020 — classified as 2 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. 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 Problem2
Patient problems
- No Code Available2
- Blurred Vision1
- Halo1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2020Adverse 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 FROM THE PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING A MECHANICAL FAILURE. THROUGH FOLLOW-UP, IT WAS LEARNED THE MECHANICAL FAILURE WAS DIAGNOSED AS TO THE CAUSE OF THE PATIENT'S COMPLAINT OF BLURRY AND FUZZY VISION. THE PATIENT WAS UNABLE TO PROCESS CLEAR VISION THROUGH THE IMPLANT. A NEW INCISION WAS REQUIRED, HOWEVER, THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS MODEL ZCU450, LOWER DIOPTER (21.5) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 10405618 ↗InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXT375 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S OPERATIVE EYE AS THE PATIENT WAS UNABLE TO TOLERATE GLARE AND HALOS AT NIGHT. THE EXPLANT SURGERY WAS UNEVENTFUL, NO INCISION ENLARGEMENT WAS REQUIRED. THE IOL WAS REPLACED WITH A MODEL ZCT450 LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; No Code Available
MAUDE report 6720028 ↗
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- 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.
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