TECNIS IOL ZCT300 (REF ZCT300U115)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 11.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553156), received between Jan 10, 2019 and Jun 14, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2019Mechanical Problem; Mechanical Problem
THE SURGERY CENTER REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZCT300 11.5 DIOPTER WAS EXPLANTED DUE TO UNDEFINED MECHANICAL COMPLICATIONS, WRONG POWER/ WRONG DIOPTER. THERE WAS NO SURGICAL INTERVENTION REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (15.0) WAS USED. IT WAS NOTED THAT THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8702176 ↗InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 11.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN A SECONDARY PROCEDURE. REPORTEDLY, SUTURES WERE USED DURING THE PROCEDURE. LENS WITH MODEL ZLB00 +20.0 DIOPTER WAS USED AS THE REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 8238359 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page