TECNIS IOL ZCU300 (REF ZCU300U210)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 21.0D CYL3.00 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474660175), received between Nov 16, 2020 and Dec 21, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AT THE STUDY PATIENT'S OPERATIVE VISIT THE ACTUAL INTRAOCULAR (IOL) AXIS PLACEMENT WAS 174 DEGREES FOR THE FIRST OPERATIVE LEFT EYE (OS). THE PATIENT'S SLIT LAMP AXIS MEASUREMENT AT THE FIRST EYE OS 1 DAY POST-OPERATIVE VISIT WAS RECORDED AS 001 DEGREES. THE PATIENT'S 1 WEEK FIRST EYE, OS, POST-OPERATIVE VISIT SLIT LAMP AXIS MEASUREMENT WAS RECORDED AS 004 DEGREES. THIS IS A 10 DEGREE ROTATION OF THE IOL AS COMPARED TO THE AXIS PLACEMENT. IT WAS NOTED THAT THE UNCORRECTED VISUAL ACUITY OS AT THE 1-WEEK POSTOPERATIVE VISIT: 20/25. MANIFEST REFRACTION: 0.00 +0.75 X13. BEST-CORRECTED DISTANCE VISUAL ACUITY: 20/25. SUBJECT REPORTED NO VISUAL SYMPTOMS AT THIS VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11049638 ↗InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO RESIDUAL MYOPIA WHICH STARTED ONE DAY POST-IMPLANTATION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Therapeutic Effects, Unexpected
MAUDE report 10849553 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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