TECNIS IOL PCB00 (REF PCB0000295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474558458), received between Mar 29, 2017 and Sep 9, 2021 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

1. Jun 21, 2018Terminated

   Expired intraocular lenses were distributed.

   Z-0464-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE WAS CRACKED. THE INTRAOCULAR LENS (IOL) MODEL PCB00 ENDED UP NOT BEING ABLE TO COME THROUGH THE TIP AND POSSIBLY GOT DAMAGED DUE TO THE CRACKED CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451503 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED AND REPLACED FROM PATIENT'S RIGHT EYE (OD) DUE TO SURPRISE REFRACTIVE ERROR 3.25. AT EXPLANT THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. VISUAL ACUITY (VA) PRE-OPERATIVE: (B)(6) 2019: OD 6.75 + 0.75 X 178, VA POST-OPERATIVE: (B)(6) 2020: OD 3.25 + 0.75 X 162, VA MARCH 11, 2020: 3.25 + 0.60 X 177.

  Patient problems: No Code Available

  MAUDE report 10187402 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD DECREASED VISUAL ACUITY AFTER THE IMPLANTATION OF PCB00 +29.5 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+28.0). NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8206989 ↗
• MalfunctionNov 27, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT UPON INSERTION OF A PCB00 29.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, DOCTOR NOTICED THE HAPTIC WAS BENT/BROKEN AND ANOTHER LENS WAS INSERTED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CUSTOMER ALSO INDICATED THAT THE IOL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109351 ↗
• MalfunctionSep 18, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE, MULTIPLE LINT FIBERS ATTACHED TO THE UNDERSIDE OF THE LENS WERE NOTICED. THE FOREIGN MATERIAL WAS REMOVED BY ASPIRATION AND NO INJURY TO THE PATIENT OR WOUND ENLARGEMENT WAS NECESSARY. THE LENS REMAINS IMPLANTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7884656 ↗
• InjuryAug 28, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT A PCB00 29.5 DIOPTER LENS CAME OUT OF THE INJECTOR TOO SOON WHEN INSERTING INTO THE PATIENT'S RIGHT EYE (OD). THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS AN INCISION ENLARGEMENT MADE, BUT NO SUTURES WERE USED. REPORTEDLY, THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7823003 ↗
• InjuryAug 28, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT A PCB00 29.5 DIOPTER LENS CAME OUT OF THE INJECTOR TOO SOON WHEN INSERTING INTO THE PATIENT'S RIGHT EYE (OD). THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS AN INCISION ENLARGEMENT MADE, BUT NO SUTURES WERE USED. REPORTEDLY, THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7822912 ↗
• InjuryJul 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS PRELOADED MONOFOCAL INTRAOCULAR LENS (MODEL PCB00, +29.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. THERE WAS NO PATIENT INJURY, NO MEDICAL OR SURGICAL INTERVENTION AND NO INCISION ENLARGEMENT PERFORMED. REPORTEDLY, THE SAME MODEL LENS, A LARGER DIOPTER, +25.5 WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7717083 ↗
• MalfunctionJul 13, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER THE SECOND PUSH, THERE WAS A LITTLE PIECE OF PLASTIC THAT WAS TURNED UP AT THE END/TIP OF THE CARTRIDGE. IT IS THOUGHT THAT THE END OF THE CARTRIDGE WAS A LITTLE DAMAGED. THE DOCTOR SAW IT UNDER THE MICROSCOPE. THERE WAS NO PATIENT INJURY. THERE WAS NO CONTACT BETWEEN THE LENS AND THE PATIENTS EYE. THE DOCTOR TOOK ANOTHER LENS AND IMPLANTED IT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6713020 ↗
• InjuryMar 29, 2017Break; Device Handling Problem; Break; Device Handling Problem

  IT WAS REPORTED THAT A PCB00 29.5 DIOPTER WAS EXPLANTED DUE TO A BROKEN HAPTIC AND WAS NOTED TO BE A HANDLING ERROR BY THE USER. IT WAS REPORTED THAT A SEPARATE PROCEDURE WAS NECESSARY TO EXPLANT THE LENS. INCISION ENLARGEMENT AND SUTURE WERE REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL AND SAME SIZE LENS. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6444998 ↗