TECNIS IOL PCB00 (REF PCB0000095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474558052), received between Mar 14, 2017 and Jun 9, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC/ARM OF THE INTRAOCULAR (IOL) LENS WAS DEFECTIVE AS IT WAS MISSING. THE ISSUE OCCURRED PRIOR TO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101792 ↗
• InjuryApr 16, 2018Kinked; Kinked

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED IN THE SAME SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DOCTOR IMPLANTED THE LENS AND THEN OBSERVED A KINKED HAPTIC. THE LENS WAS REMOVED AND REPLACED REQUIRING AN INCISION ENLARGEMENT AND SUTURES. THE REPLACEMENT LENS USED WAS THE SAME MODEL AND DIOPTER. NO PATIENT INJURY REPORTED AND THE PATIENT WAS NOTED TO BE DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7435279 ↗
• InjuryMar 22, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL PCB00, +9.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING DECREASE IN VISUAL ACUITY AND PHOTOPHOBIA. A MODEL PCB00, +19.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7364255 ↗
• InjuryMar 15, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PCB00 9.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO DECREASED VISUAL ACUITY AND PHOTOPHOBIA. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7343376 ↗
• InjuryMar 14, 2017Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) GOT CAUGHT IN THE INCISION DURING IMPLANTATION INTO THE LEFT EYE OF (B)(6) FEMALE PATIENT. REPORTEDLY, THE LENS HAD TO BE REMOVED DURING THE SAME SURGICAL PROCEDURE. THE INCISION WAS ENLARGED BUT NO SUTURE USED, NO VITRECTOMY AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6404640 ↗