TECNIS IOL ZCT300 (REF ZCT300U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 16.0D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553248), received between Mar 16, 2017 and Aug 17, 2017 — classified as 3 injuries.
The most frequently reported specific device problem is “Torn Material” (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
- Torn Material1
- Unintended Movement1
Patient problems
- No Code Available3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2017Torn Material; Torn Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TORN DURING INSERTION INTO THE EYE. REPORTEDLY, THE INCISION WAS ENLARGED AND THE LENS WAS CUT OUT. THE PATIENT WAS REPORTED DOING OK. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6799714 ↗InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZCT300 +16.0 DIOPTER, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A PATIENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. THE LENS WAS REPLACED WITH ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+15 DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6546673 ↗InjuryMar 16, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION. REPORTEDLY, THE SURGEON WAS PLANNING ON KEEPING THE LENS IN THE PATIENT'S EYE AND REPOSITIONING THE LENS IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS ROTATED BY 15 DEGREES AND IT WAS REPOSITIONED ON (B)(6) 2017. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6412070 ↗
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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