TECNIS IOL PCB00 (REF PCB0000085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474558038), received between Sep 9, 2016 and Jan 13, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2020Break; Break

  IT WAS REPORTED THAT DURING A POST-OPERATIVE EXAMINATION, THE INTRAOCULAR LENS, MODEL PCB, IMPLANTED IN THE PATIENT'S EYE, WAS OBSERVED WITH A BROKEN HAPTIC. SURGEON DECIDED TO REMOVE THE LENS DURING THE SAME PROCEDURE. IN ORDER TO REMOVE THE LENS INCISION WAS ENLARGED. ALL THE INFORMATION AVAILABLE WERE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9583499 ↗
• MalfunctionMay 24, 2019Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD MISSING COMPONENT SPECIFIED AS TIP. PRODUCT DID NOT HAVE PATIENT CONTACT WITH THE EYE. ADDITIONAL INFORMATION STATES THAT THE TIP(END) OF THE LENS DID NOT LOOK RIGHT, IOL SEEMED DEFECTIVE AND THE LENS WOULD NOT ADVANCE TO THE END. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8642888 ↗
• InjuryMar 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) SLID PAST THE PLUNGER OF THE INJECTOR. PATIENT CONTACT WAS REPORTED. REPORTEDLY THE LENS WAS NOT FULLY INSERTED AND THE INCISION HAD TO BE ENLARGED TO REMOVE THE LENS FROM THE EYE. NO SUTURE WAS USED AND NO PATIENT INJURY WAS REPORTED. ANOTHER LENS, SAME MODEL, WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6444276 ↗
• MalfunctionSep 9, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE SURGEON NOTICED PLASTIC DEBRIS THAT WAS INTRODUCED INTO THE EYE ALONG WITH THE INTRAOCULAR LENS (IOL). THE DEBRIS WAS SMALL AND LOCATED ON THE POSTERIOR SIDE OF THE IOL. SOME OF THE DEBRIS WAS ADHERED TO THE LENS ITSELF, OFTEN AROUND THE 4 O'CLOCK POSITION. THE SURGEON HAD TO ASPIRATE THE DEBRIS BY GOING UNDER THE IOL WITH AN IRRIGATION/ASPIRATION TIP AFTER IMPLANTATION AND HAD TO CHASE DOWN THE PIECE, SOMETIMES HAVING TO REMOVE IT FROM THE IOL SURFACE. THIS ISSUE ADDED TIME AND DIFFICULTY TO THE PROCEDURE; HOWEVER, THERE WERE NO COMPLICATIONS, INCISION ENLARGEMENT OR PATIENT INJURY. THE LENS REMAINS IMPLANTED AND THE PATIENT OUTCOME IS EXCELLENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5941523 ↗