TECNIS IOL ZCT300 (REF ZCT300U120)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 12.0D 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
- 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 05050474553163), received between Jun 2, 2017 and Dec 14, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (2 reports).
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
- Unintended Movement2
Patient problems
- Blurred Vision1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT300 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED ROTATED AT THE SIX MONTH FOLLOW UP VISIT WITH THE DOCTOR ON (B)(6) 2017. THE LENS ROTATED FROM 100 DEGREES TO 115 DEGREES POST-OPERATIVELY, WHICH WAS A 15 DEGREE CHANGE. THE PATIENT COMPLAINED OF MODERATE BLURRED VISION AT ALL DISTANCES. REPORTEDLY, THE PATIENT COMPLAINT DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO PATIENT COMPLICATIONS OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 7120010 ↗MalfunctionJun 2, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 79 DEGREES, WAS NOTICED AT 69 DEGREES DURING THE SIX-MONTH POST-OPERATION VISIT. REPORTEDLY, THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE LENS REMAINS IMPLANTED AND NO FURTHER ACTIONS ARE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6609728 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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