TECNIS IOL PCB00 (REF PCB0000065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474557994), received between Jan 27, 2017 and Feb 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT EYE CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION ON (B)(6) 2020, THE OPERATION WENT WELL. AFTER OPERATION, TOBRAMYCIN DEXAMETHASONE EYE OINTMENT WAS USED TO COVER THE EYES. THE PATIENT WAS REEXAMINED ON (B)(6) 2020: VISION OF LEFT EYE WAS 0.8, CONJUNCTIVA WAS NOT HYPEREMIA AND DETUMESCENCE, CORNEA WAS DETUMESCENCE (+), ANTERIOR CHAMBER WAS OFTEN DEEP, TYN (+), PUPIL WAS OFTEN LARGE, INTRAOCULAR LENS WAS IN POSITIVE POSITION, AND OTHER STRUCTURES WERE (-). INTRAOCULAR PRESSURE: 16.7MMHG, THE PATIENT WAS GIVEN MYDRIASIS IMMEDIATELY. TOBRAMYCIN DEXAMETHASONE EYE DROPS FREQUENTLY AND OTHER SYMPTOMATIC TREATMENT. THE PATIENT WAS REEXAMINED ON (B)(6) 2020: 0.8 IN LEFT EYE, NO CONGESTION AND SWELLING OF CONJUNCTIVA, CORNEAL ENDOTHELIAL FOLD (+), ANTERIOR CHAMBER OFTEN, TYN (-), PUPIL IS OFTEN LARGE, INTRAOCULAR LENS IS IN POSITIVE POSITION, AND OTHER STRUCTURES ARE THE SAME AS BEFORE. AT PRESENT, THE PATIENT'S CONDITION IS IMPROVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 11325520 ↗
• MalfunctionJan 27, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FIBROUS MATERIAL BETWEEN THE HAPTIC AND THE OPTIC OF AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE SURGEON USED AN INSTRUMENT TO REMOVE IT AND KEPT THE LENS IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6282013 ↗