TECNIS IOL ZXR00 (REF ZXR00U0050)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 05.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474591547), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT REPORTED HAVING SEVERE HALOS WITH HEADLIGHTS AND STREET LIGHTS, HAS TROUBLE READING AT DISTANCE, AND READING SIGNS WHILE DRIVING. FURTHERMORE, SHE HAD DIFFICULTY READING LETTERS ON NON-WHITE BACKGROUNDS AND IT TAKES AWHILE FOR HER EYES TO FOCUS. THE PATIENT STATED THE LENSES SEEM DIRTY AS HER VISION IS CLOUDY. SHE HAS FLOATERS, WHICH AFFECTS HER VISION AND HAS DIFFICULTY READING FOR A SPLIT SECOND. THE PATIENT STATED THAT HER VISION IS BLURRY AT A DISTANCE, BUT SHE IS ABLE TO WORK ON HER COMPUTER WITH NO ISSUES. THERE ARE NO PLANS TO PERFORM ANY ADDITIONAL TREATMENTS. HER DOCTOR REPORTS THAT THERE IS NOTHING WRONG WITH HER EYES. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available; Visual Disturbances
MAUDE report 7755306 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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