TECNIS IOL PCB00 (REF PCB0000310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474558489), received between May 4, 2017 and Feb 18, 2022 — classified as 3 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS IMPLANTED, BUT APPEARED TO FLIP WHICH CAUSED A CAPSULAR RUPTURE AND REQUIRED THE VITRECTOMY PROBE TO BE USED. ALTHOUGH THE CAPSULE WAS STABLE, THE SURGEON DECIDED TO REMOVE THE IOL. IT WAS DECIDED NOT TO IMPLANT ANOTHER IOL UNTIL THE EYE HAD SETTLED. THE LENS WAS INJECTED AS NORMAL AND THE SURGEON WAS UNSURE WHY IT HAD TURNED/ FLIPPED. THE LENS WAS INSERTED AND REMOVED DURING SAME PROCEDURE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 13564585 ↗
• MalfunctionFeb 25, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE INSERTER OF THE PRELOADED DEVICE BENT OVER THE INTRAOCULAR LENS (IOL) INSTEAD OF PUSHING IT OUT. THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11378708 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 31.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. AT DAY 1 POST-OP, PATIENT REPORTED TO HAVE EXPERIENCED BLURRY VISION AND RESIDUAL ASTIGMATISM. THE LENS WAS LATER EXPLANTED ON (B)(6)2019 WITHOUT COMPLICATIONS OR FURTHER SURGICAL INTERVENTION. THE REPLACEMENT LENS IS A ZXT150 30.5 DIOPTER IOL. REPORTEDLY, PATIENT NOTICED AN IMPROVEMENT WITH HER VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9441142 ↗
• InjuryMay 4, 2017Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE INJECTOR WAS HANDLED INCORRECTLY. THE PHYSICIAN PUSHED THE PLUNGER UP TO THE FIRST LINE THEN SCREWED AND PUSHED THE LENS IN TO THE EYE. THE IMPLANT POPPED UP AND LANDED UNDER THE IRIS IN THE SULCUS. THE DOCTOR TRIED TO RETRIEVE THE LENS TO PUT THE LENS BACK IN THE BROKEN CAPSULE. THE IRIS WAS TORN. THE IMPLANT WENT UP THE ANTERIOR CHAMBER BUT AS THE CHAMBER WAS NARROW, THE IMPLANT PASTED TO THE ENDOTHELIUM. WHICH WILL REQUIRE A CORNEAL TRANSPLANT. THE SURGERY WAS ALSO DELAYED BY 30 MINUTES. DEVICE IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6546177 ↗