TECNIS IOL PCB00 (REF PCB0000300)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 30.0D · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474558465), received between Aug 28, 2018 and Jan 18, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Eject” (1 report).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 21, 2018Terminated
Expired intraocular lenses were distributed.
Z-0464-2019 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Failure to Eject1
- Manufacturing, Packaging or Shipping Problem1
- Material Fragmentation1
Patient problems
- No Code Available2
- Corneal Edema1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2020Failure to Eject; Failure to Eject
IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS GOT STUCK IN CARTRIDGE WHILE INSERTING LENS INTO THE EYE. REPORTEDLY THERE WAS PATIENT CONTACT AND LENS WAS PARTIALLY INSERTED. LENS WAS EJECTED FROM INJECTOR PRIOR TO COMPLETELY IN-PATIENT EYE. FURTHER THE LENS WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER IN SAME SURGICAL PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9604688 ↗InjuryJan 6, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING CATARACT SURGERY, AN INTRAOCULAR LENS, MODEL PCB00, HAD TRAILING HAPTIC MISSING. LENS WAS REMOVED AND REPLACED RESULTING IN AN EXTENDED INCISION WHICH REQUIRED SUTURING. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 9550309 ↗InjuryAug 28, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL PCB00 +30.0 DIOPTER) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. REPORTEDLY, THE SURGEON BELIEVES THAT THE LENS IS EITHER FAULTY OR MISLABELED AND THEREFORE WILL EXPLANT THE LENS. VISUAL ACUITY (VA) PRE-OPERATIVE: 4/10, VA POST-OPERATIVE : MYOPIA -10. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Corneal Edema; No Code Available
MAUDE report 7822332 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.