TECNIS IOL ZCU375 (REF ZCU375U065)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 06.5D 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
- 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 05050474700291), received between Apr 29, 2023 and Apr 29, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING DIFFICULTY READING WITH THE IMPLANTED INTRAOCULAR LENS (IOL) IN THE RIGHT/LEFT EYE, WHICH STARTED SOON AFTER SURGERY IN (B)(6) 2022. AN IOL EXCHANGE WITH A SYNERGY IOL IS PLANNED FOR (B)(6) 2023. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH NORMAL DAILY ACTIVITIES, INCLUDING NIGHT DRIVING. THE PRE-OPERATIVE TARGET REFRACTIVE VALUE WAS -0.25 AND THE FINAL REFRACTIVE VALUE POST-OPERATIVE WAS +-0.50. THROUGH FURTHER FOLLOW-UP, IT WAS LEARNED THAT THE EXPLANT HAS BEEN PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR RIGHT EYE, A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16841124 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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