TECNIS IOL ZCB00 (REF ZCB0000305)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 30.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474531925), received between Apr 2, 2018 and Jun 9, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT A NON-PRELOADED INTRAOCULAR LENS CRACKED DURING INSERTION AND WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446214 ↗InjuryMar 31, 2020Break; Break
IT WAS REPORTED THAT A ZCB00 IOL 30.5 DIOPTER WAS INSERTED INTO THE PATIENT¿S OPERATIVE EYE. AFTER INSERTION THE DOCTOR NOTICED A TEAR IN THE LENS. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH THE SAME MODEL. THE INCISION WAS ENLARGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9908582 ↗InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) A TEAR WAS NOTICED IN THE CAPSULAR BAG AND THE LENS HAD TO BE REMOVED FROM THE EYE. REPORTEDLY THE LENS WAS FULLY INSERTED AND REMOVED WITHOUT ENLARGING THE INCISION. A VITRECTOMY WAS REQUIRED. A REPLACEMENT LENS (MODEL AND DIOPTER UNKNOWN) WAS IMPLANTED IN THE SULCUS. THE PATIENT WAS REPORTED DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear; Vitrectomy
MAUDE report 7389303 ↗
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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