TECNIS IOL ZXR00 (REF ZXR00U0095)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 09.5D · 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 05050474591639), received between Aug 28, 2017 and Feb 16, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Appropriate Device Problem Term/Code Not Available1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Blurred Vision1
- Eye Pain1
- Macular Edema1
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem
THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTED, SHORTLY AFTER THE SURGERY, COMPLAINTS OF OD BEING UNCOMFORTABLE-IRRITATING, SORE, FEELS LIKE SHE WORE CONTACT LENSES TOO LONG. SHE USES ARTIFICIAL TEARS WHEN NEEDED. PATIENT REPORTED UNCOMFORTABLE FEELING AS SAME OR BETTER NOW. PATIENT CAN SEE THE OUTLINE OF THE IOL, WHICH WAS NOTICED RIGHT AFTER SURGERY. NEAR VISION IS POOR AND HAS DIFFICULTY WORKING ON THE COMPUTER AND READING. RESULTS ARE NOT AS EXPECTED. DISTANCE VISION IS GOOD, APPROXIMATELY 20/25. OD HAD CLOUDINESS WHICH WAS CORRECTED BY LASER, CLOUDINESS IS NOW BETTER. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING OD IS ESPECIALLY BLURRY AND POSSIBLE SWELLING OF THE RETINA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR SINISTER (LEFT EYE).
Patient problems: Blurred Vision; Eye Pain; Macular Edema; Visual Disturbances
MAUDE report 11335955 ↗InjuryAug 28, 2017Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED A ZXR00 9.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A UNSPECIFIED LENS MALFUNCTION. THE LENS WAS REPLACED WITH THE SAME MODEL ZXR00, BUT LOWER DIOPTER OF 8.0. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6826248 ↗
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.
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