TECNIS IOL ZCB00 (REF ZCB0000070)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 7.0D · 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 05050474531451), received between Jun 20, 2017 and Jul 10, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged Prior to Use1
- Scratched Material1
Patient problems
- Blurred Vision1
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BLURRY VISION. THIS WAS REPLACED WITH ZCT600, 10.0 DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT IS VERY HAPPY WITH THEIR VISION: VISUAL ACUITY 20/40 -2 CORRECTION AFTER EXCHANGE. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 10256464 ↗MalfunctionJun 20, 2017Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use; Scratched Material
IT WAS REPORTED THAT THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) UPON REMOVING THE LENS FROM THE PACKAGE. NO PATIENT CONTACT OR INJURY WAS REPORTED. ANOTHER AMO LENS WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6655762 ↗
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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