TECNIS IOL ZCB00 (REF ZCB0000320)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 32.0D · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474531956), received between Jun 19, 2017 and Mar 31, 2021 — classified as 2 injuries.
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 Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Intraocular Pressure Increased1
- Visual Impairment1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO REFRACTIVE SURPRISE AND ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER (ZA9003 11.5D) WAS PLACED. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE EVENT WAS OBSERVED DURING POST-OP EXAMINATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 11599721 ↗InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCB00 32.0 DIOPTER WAS INSERTED AND REMOVED FROM A MALE PATIENT'S EYE DUE TO HIGH INTRAOCULAR PRESSURE. THROUGH FOLLOW UP, THE CUSTOMER STATED THAT SHE DOES NOT BELIEVE THE LENS CONTRIBUTED TO THE PATIENT HAVING HIGH PRESSURE AND IS MOST LIKELY DUE TO THE PATIENT. CUSTOMER INDICATED THAT A VITRECTOMY WAS PERFORMED AND THE PHYSICIAN NOTICED THE HIGH PRESSURE. THERE WAS NO INCISION ENLARGEMENT. ADDITIONALLY, THE CUSTOMER STATED THAT AFTER THE LENS WAS IMPLANTED THE SURGEON DISCOVERED A POSTERIOR CAPSULE RUPTURE. THERE WAS NO REPLACEMENT LENS AVAILABLE. THE PHYSICIAN ALSO NOTED THAT THE PATIENT HAD A PROLAPSE AND THE CORNEA WAS CLOUDY. THE PATIENT WAS DOING FINE WHEN DISCHARGED.
Patient problems: Capsular Bag Tear; Intraocular Pressure Increased; Vitrectomy
MAUDE report 6652237 ↗
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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