TECNIS IOL ZCU300 (REF ZCU300U215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 21.5D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474660182), received between Jan 19, 2022 and Feb 26, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error1
- Break1
- Difficult to Fold, Unfold or Collapse1
- Ejection Problem1
Patient problems
- Capsular Bag Tear1
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2024Break; Ejection Problem; Break; Ejection Problem
IT WAS REPORTED THAT THREE JOHNSON AND JOHNSON INTRAOCULAR LENSES (IOLS) DID NOT WORK RIGHT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE THIRD LENS EVENT. SEPARATE REPORTS WILL BE SUBMITTED TO CAPTURE THE FIRST AND SECOND LENS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784689 ↗InjuryDec 14, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THE ZCU300 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OCULAR DEXTER (RIGHT EYE) DUE TO A POWER VARIANCE WITH PREVIOUS LASIK AND REPLACED WITH A ZCU150 22.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO ENLARGEMENT AND NO SUTURE. PATIENT OUTCOME WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Discomfort
MAUDE report 15983821 ↗InjuryJan 19, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT LENS CAPSULE BROKE AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED DUE TO HAPTIC MANIPULATION. THE LENS WAS REMOVED FROM THE PATIENT'S EYE. IT WAS INDICATED THAT SUTURES WERE REQUIRED AND THERE WAS A 20-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS 20/60 -2 WITH GLASSES. THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/40 UNCORRECTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 13299880 ↗
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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