TECNIS IOL PCB00 (REF PCB0000325)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 32.5D · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474558519), received between May 18, 2018 and Apr 8, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Eject1
- Material Integrity Problem1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PCB00 32.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT¿S OPERATIVE EYE AND AN INCISION ENLARGEMENT WAS REQUIRED. THE PCB00 32.5 DIOPTER LENS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL & DIOPTER. PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 9936660 ↗MalfunctionMay 22, 2019Failure to Eject; Failure to Eject
IT WAS REPORTED THAT WHEN USING PCB00 32.5 DIOPTER THE PLUNGER WOULD NOT TURN AND WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT BUT THERE WERE NO COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THE PATIENT IS DOING FINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8634294 ↗MalfunctionMay 18, 2018Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BEFORE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT THE CARTRIDGE TIP WAS DAMAGED. THE IOL WAS NOT IMPLANTED. THE IOL WAS NOT USED NOR DID IT COME IN CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.
Patient problems: No Patient Involvement
MAUDE report 7528026 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page