TECNIS IOL ZCT450 (REF ZCT450U165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 16.5D CYL4.50 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474602915), received between Aug 7, 2017 and Jul 30, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2019Break; Break
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8844315 ↗MalfunctionNov 20, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT450, 16.5 DIOPTER INTRAOCULAR LENS (IOL) STUDY LENS WAS PLACED AT OS (LEFT EYE) 113 DEGREES AT SURGERY ((B)(6) 2016) AND WAS MEASURED AT THE 1 MONTH STUDY VISIT ((B)(6) 2016) AT 102 DEGREES. IT WAS STATED THAT THERE WAS NO PATIENT INJURY. THE OUTCOME DID NOT EFFECT THE PATIENT'S DAILY LIFE ACTIVITY. THERE WAS NO LENS REPOSITIONING DONE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE PATIENT WAS DOING FINE AS OF THEIR FINAL STUDY VISIT AND EXIT DATE ON (B)(6) 2016. REPORTEDLY AT THAT VISIT, THE IOL AXIS OS WAS RECORDED AS 116 DEGREES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8092489 ↗InjuryAug 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED THAT A TECNIS MONOFOCAL MODEL ZCT450 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS PLANNED FOR EXPLANT FROM A PATIENT¿S LEFT OPERATIVE EYE AS THERE WAS NEARLY 2.00 DIOPTERS OF RESIDUAL ASTIGMATISM. THE SURGERY CENTER INDICATED THE PATIENT REQUIRED A ZCT600 17.0 DIOPTER IOL TO CORRECT THE PROBLEM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6772537 ↗
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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