TECNIS IOL ZXR00 (REF ZXR00U0080)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 08.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474591608), received between Feb 2, 2017 and Mar 26, 2020 — classified as 3 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Code Available2
- Blurred Vision1
- Dry Eye(s)1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 IOL 8.0 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT REPORTED THAT HER VISION AFTER THE SURGERY WAS VERY GOOD. BUT NOW HER VISION BECAME BLURRY AND SEEMED TO HAVE DECREASED. PER THE PATIENT, HER DOCTOR SAID THAT HER SYMPTOMS ARE NOT DUE TO THE LENS. PER THE DOCTOR HER GLANDS ARE CLOGGED. THE PATIENT SAID THAT IT MAKES SENSE TO HER. THE DOCTOR LOWERED HER DOSE OF THE PRESCRIPTION EYE DROPS PREDNISOLONE AND INCREASED THE OVER THE COUNTER DRY EYE DROPS (NAME NOT PROVIDED). THE PATIENT INQUIRED ABOUT LASER PROCEDURES WHICH THE DOCTOR MENTIONED AS A POSSIBILITY. I EXPLAINED TO HER WHAT A LASER PROCEDURE WAS. THE PATIENT WAS SATISFIED WITH THE ANSWER. NO MORE INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment
MAUDE report 9884690 ↗InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 8.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019, DUE TO AN UNSPECIFIED INJURY. A REPLACEMENT LENS OF SAME MODEL AT A LOWER DIOPTER (5.0) WAS IMPLANTED. NO COMPLICATIONS HAVE BEEN REPORTED POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9159418 ↗InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO ANISOMETROPIA. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6295414 ↗
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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