TECNIS IOL ZCU300 (REF ZCU300U250)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 25.0D CYL3.00 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474660250), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unstable” (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 18, 2026.
Most reported problems
Device problems
- Unstable1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2021Unstable; Unstable
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD ROTATION OF APPROXIMATELY 10 DEGREES. THE STUDY PATIENT'S PRE-OP BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) LEFT EYE (OS) WAS 20/40. UNCORRECTED VISUAL ACUITY OS AT THE 1-DAY POSTOPERATIVE VISIT: 20/40. SUBJECT REPORTED NO VISUAL SYMPTOM COMPLAINTS IN THIS VISIT. OUTCOME DOESN'T SIGNIFICANTLY INTERFERE WITH THE PATIENT'S REGULAR ACTIVITIES. AT THE 1-WEEK STUDY VISIT UNCORRECTED VISUAL ACUITY (VA) OS WAS 20/25, MANIFEST REFRACTION OS WAS +0.50 -0.50 X076, BEST-CORRECTED VA OS WAS 20/20. PATIENT¿S ONLY VISUAL SYMPTOM COMPLAINT WAS ¿COLOR DISTORTION¿. SUBJECT TO RETURN FOR THE 3-MONTH STUDY VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. IT WAS LEARNED THAT THE COMPLAINT STUDY WAS BASED UPON A SUBJECTIVE ESTIMATE MADE BY THE INVESTIGATOR FROM A SLIT-LAMP MEASUREMENT. FOR THIS STUDY, INDEPENDENT ANALYSIS OF THE IOL PHOTOS TAKEN AT EACH VISIT. THESE ARE OBJECTIVE MEASUREMENTS OF THE ACTUAL IOL AXIS. BASED ON THIS OBJECTIVE MEASUREMENT, THE ACTUAL AMOUNT OF IOL ROTATION FOR THE SUBJECT BELOW IS LESS THAN 01 DEGREE. THERE IS STILL NO SURGICAL INTERVENTION PLANNED. THE SUBJECT IS CONTINUING IN THE STUDY. THERE IS NO FURTHER INF
Patient problems: Visual Disturbances
MAUDE report 11363910 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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