TECNIS IOL PCB00 (REF PCB0000340)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 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
- 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 05050474558540), received between Apr 3, 2019 and Dec 12, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT A CRACK AT THE JUNCTION OF THE HAPTIC AND THE LENS WAS FOUND. IT WAS DESCRIBED AS A SMALL TEAR RADIAL TOWARDS THE CENTER OF THE LENS ON THE PERIPHERAL EDGE, CLOCKWISE TO THE TRAILING HAPTIC. THE LENS IS FULLY INSERTED AND DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. A DELAY OF 5 MINUTES WAS REPORTED AND NO INTERVENTIONS WERE MENTIONED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15959767 ↗MalfunctionJun 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT A LENS WAS TORN. THE ISSUE WAS FIRST IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14639126 ↗InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A DECREASE OF VISUAL ACUITY AFTER THE IMPLANTATION OF +34.0 DIOPTER LENS MODEL, PCB00 MONOFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH +35.0 DIOPTER NON-JOHNSON AND JOHNSON PRODUCT. PATIENT WAS REPORTEDLY DOING WELL AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Impairment
MAUDE report 8476886 ↗
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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