TECNIS IOL ZCB00 (REF ZCB0000340)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 34.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474531994), received between Aug 9, 2020 and Aug 9, 2020 — classified as 1 injury.
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
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT SURGEON WAS PLANNING TO PERFORM EXPLANT IN SECONDARY SURGICAL PROCEDURE ON PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING LARGE REFRACTIVE ERROR. REPORTEDLY SURGEON DOES NOT BELIEVE THERE WAS ANYTHING WRONG WITH THE LENS. THE ISSUE WAS THAT CATARACT WAS VERY DENSE AND HARD TO GET ACCURATE BIOMETRY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT EXPLANT WAS PERFORMED AS PLANNED ON (B)(6) 2020. LENS WITH SAME MODEL AND LOWER DIOPTER WAS USED AS REPLACEMENT LENS. THERE WAS NO PATIENT INJURY. SUTURE WAS USED AFTER THE REPLACEMENT LENS WAS PLACED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 10383097 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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