TECNIS IOL PCB00 (REF PCB0000315)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 31.5D · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474558496), received between Jul 21, 2020 and Aug 14, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (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.
Most reported problems
Device problems
- Failure to Eject2
- Break1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020Failure to Eject; Failure to Eject
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE PATIENT¿S LEFT EYE, IOL GOT STUCK IN CARTRIDGE, DID NOT ADVANCE, BUT WAS ALREADY PARTIALLY INSERTED, AND THEN REMOVED. THE BACK-UP LENS WAS USED. PATIENT IS FINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10411570 ↗MalfunctionJul 21, 2020Break; Failure to Eject; Break; Failure to Eject
IT WAS REPORTED THAT LENS DIDN'T DEPLOY RIGHT IN CARTRIDGE BECAUSE HAPTICS WERE BROKEN. LENS CONTACTED PATIENT¿S EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT CARTRIDGE TOUCHED EYE LENS WOULD NOT DEPLOY. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10305694 ↗
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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