TECNIS IOL ZCB00 (REF ZCB0000085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS 1-PC CLEAR MONO 6.0MM 8.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474531482), received between Apr 3, 2017 and May 10, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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 16, 2026.
Most reported problems
Device problems
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Patient Involvement2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2021Adverse 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 FROM THE PATIENT'S OPERATIVE EYE DUE TO THE PATIENT HAS KERATOCONUS. VISUAL ACUITY PRE-OP: 20/400 20/70 +2 UNCORRECTED - PINHOLE. VISUAL ACUITY POST-OP: 20/200 20/40 +2 UNCORRECTED - PINHOLE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS VERY HAPPY WITH THE OUTCOME. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11803471 ↗MalfunctionJun 22, 2018Scratched Material; Scratched Material
IT WAS REPORTED THAT THERE WAS DEFECTIVE PRODUCT AND INTRAOCULAR LENS WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7630236 ↗MalfunctionApr 3, 2017Scratched Material; Scratched Material
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OBSERVED SCRATCHED WHEN REMOVING IT FROM THE PACKAGING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6455410 ↗
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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