TECNIS IOL PCB00 (REF PCB0000060)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 6.0D · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474557987), received between Jul 25, 2019 and Dec 29, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Contamination1
- Failure to Eject1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2020Break; Break
IT WAS REPORTED THAT LENS WAS DEFECTIVE. NO INFORMATION IF PATIENT WAS INVOLVED. AFTER SEVERAL FOLLOW-UPS NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 11091554 ↗MalfunctionMar 20, 2020Failure to Eject; Failure to Eject
IT WAS REPORTED THAT A PCB00 PRELOADED INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2020. THE LENS WOULD NOT ADVANCE IN THE PRELOADED INSERTER WHILE INSERTING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP LENS OF THE SAME MODEL. THERE WAS NO SURGICAL INTERVENTION PERFORMED DURING THE REPLACEMENT PROCESS. THE CURRENT PATIENT STATUS WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9858529 ↗MalfunctionJul 25, 2019Contamination; Contamination
IT WAS REPORTED THAT AFTER THE INJECTION OF AN INTRAOCULAR LENS, MODEL PCB00 IN THE PATIENT'S RIGHT EYE, A WHITE PLASTIC PIECE MEASURING ABOUT 0.5 MM WAS FOUND ATTACHED TO THE EDGE OF THE IOL, LATER FREEING AND FLOATING IN THE ANTERIOR CHAMBER. A CAPSULORHEXIS FORCEPS WAS USED TO EXTRACT IT. PIECE REMOVED IMMEDIATELY FROM EYE WITH NO ILL EFFECT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8825052 ↗
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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