TECNIS IOL ZCU300 (REF ZCU300U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 16.0D 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 05050474660076), received between Sep 8, 2020 and Sep 23, 2024 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Break; Break
THE SURGERY CENTER REPORTED OF FOLDING ISSUE/BENT HAPTIC WITH TWO TORIC INTRAOCULAR LENSES (IOLS). THE EXTENT OF PATIENT CONTACT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS REPORTED. THIS MDR REPORT PERTAINS TO ZCU300 LENS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ZCU225 LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276500 ↗InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUSPECT LENS WAS SWITCHED TO A 3-PC. LENS. THE SUSPECT LENS WAS CUT OUT AND CONFIRMED THAT THE INCISION WAS ENLARGED SLIGHTLY TO CUT OUT LENS. ALSO, AN UNPLANNED SUTURE AND VITRECTOMY WERE PERFORMED. IT WAS LEARNED THAT THE SUSPECT LENS WAS DISCARDED. THERE WAS NO PATIENT POST-OP COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Vitrectomy
MAUDE report 10505298 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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