TECNIS IOL PCB00 (REF PCB0000305)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474558472), received between Dec 29, 2016 and Dec 12, 2022 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2022Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  IT WAS REPORTED BY THE JOHNSON & JOHNSON REPRESENTATIVE THAT THE SURGEON IS NOT USED TO THE PCB00 MODEL AND, ACCORDING TO EYEWITNESSES, DID NOT PROPERLY PREPARE THE LENS AS PER THE DIRECTIONS FOR USE (DFU). ACCORDING TO THE OPERATING TEAM, THE LENS WITH SN (B)(4) HAD A HAPTIC RIPPED OFF WHICH WAS FOUND WHEN THE LENS WAS ALREADY INSIDE THE EYE. THE LENS WAS REMOVED IT AND REPLACED WITH A SECOND UNIT, SN (B)(4) WHICH WAS ALSO DAMAGED IN THE OPTIC WITH A SCRATCH, BUT NOT BROKEN AND REMAINS IMPLANTED. ACCORDING TO WHAT THE DOCTOR REPORTED, THE PATIENT SUFFERED DAMAGE TO THE ENDOTHELIUM DUE TO THE REMOVAL AND THE EXTRA TIME THE CATARACT SURGERY TOOK, WHICH MADE THE PATIENT MOVE AND THE SURGERY MORE DIFFICULT. THE PATIENT WAS TEMPORARILY IMPAIRED AND HAD TO SEEK MEDICAL ATTENTION. THROUGH FOLLOW-UP WITH THE JOHNSON & JOHNSON REPRESENTATIVE, WE COULD NOT CONFIRM THAT THE DOCTOR HAD INCORRECTLY PREPARED THE LENS, AS SHE WAS NOT PRESENT. GIVEN THE DETAILS RECEIVED IT MAY BE THAT NOT ENOUGH VISCOELASTIC WAS USED. THE PATIENT WAS NOT FULLY RECOVERED AND MAY NEED AN ENDOTHELIAL TRANSPLANT DUE TO THE COMPLICATIONS CAUSED BY HAVING TO REMOVE THE LENS. NO MATERIAL IS AVAILABLE AND NO FURTHER INFO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960015 ↗
• InjuryDec 12, 2022Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED BY THE JOHNSON & JOHNSON REPRESENTATIVE THAT THE SURGEON IS NOT USED TO THE PCB00 MODEL AND, ACCORDING TO EYEWITNESSES, DID NOT PROPERLY PREPARE THE LENS AS PER THE DIRECTIONS FOR USE (DFU) ACCORDING TO THE OPERATING TEAM, THE LENS WITH SN (B)(4) HAD A HAPTIC RIPPED OFF WHICH WAS FOUND WHEN THE LENS WAS ALREADY INSIDE THE EYE. THE LENS WAS REMOVED IT AND REPLACED WITH A SECOND UNIT, SN (B)(4), WHICH WAS ALSO DAMAGED IN THE OPTIC WITH A SCRATCH, BUT NOT BROKEN AND REMAINS IMPLANTED. ACCORDING TO WHAT THE DOCTOR REPORTED, THE PATIENT SUFFERED DAMAGE TO THE ENDOTHELIUM DUE TO THE REMOVAL AND THE EXTRA TIME THE CATARACT SURGERY TOOK, WHICH MADE THE PATIENT MOVE AND THE SURGERY MORE DIFFICULT. THE PATIENT WAS TEMPORARILY IMPAIRED AND HAD TO SEEK MEDICAL ATTENTION. THROUGH FOLLOW-UP WITH THE JOHNSON & JOHNSON REPRESENTATIVE, WE COULD NOT CONFIRM THAT THE DOCTOR HAD INCORRECTLY PREPARED THE LENS, AS SHE WAS NOT PRESENT. GIVEN THE DETAILS RECEIVED IT MAY BE THAT NOT ENOUGH VISCOELASTIC WAS USED. THE PATIENT WAS NOT FULLY RECOVERED AND MAY NEED AN ENDOTHELIAL TRANSPLANT DUE TO THE COMPLICATIONS CAUSED BY HAVING TO REMOVE THE LENS. NO MATERIAL IS AVAILABLE AND NO FURTHER INFO

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 15959892 ↗
• MalfunctionMar 14, 2022Material Fragmentation; Failure to Advance; Material Fragmentation; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE AND THE HAPTIC WAS FULLY DETACHED. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759105 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS DEFECTIVE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844524 ↗
• InjuryAug 28, 2019Break; Break

  IT WAS REPORTED AFTER THE INSERTION OF AN INTRAOCULAR LENS (IOL), MODEL PCB, A CRACK WAS OBSERVED ON THE LENS. ALTHOUGH, THE IOL WAS REMOVED AND REPLACED ON THE SAME VISIT USING VANNA SCISSORS, THERE WAS A DELAY TIME OF 25 MINUTES AND A SUTURE WAS REQUIRED. THE IOL WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 8939325 ↗
• MalfunctionOct 9, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AN INTRAOCULAR LENS, MODEL PCB00 HAD A BENT TIP. THE LENS WAS NOT INSERTED INTO THE PATIENT'S EYE. NO PATIENT CONTACT WITH THE PRODUCT. THE SURGEON USED THE SAME MODEL, BACK UP LENS TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7949742 ↗
• MalfunctionOct 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NURSE AND THE SURGEON HAD PREPARED THE INTRAOCULAR LENS (IOL) AS PER THE DIRECTIONS FOR USE. THE SURGEON WAS ABOUT TO IMPLANT THE IOL INTO THE PATIENT¿S EYE BUT NOTICED A WHITE MARK ON THE LENS. HEALON WAS USED AS A VISCOELASTIC. THERE WAS NO PATIENT INVOLVEMENT/USER INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6986229 ↗
• MalfunctionOct 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NURSE AND THE SURGEON HAD PREPARED THE INTRAOCULAR LENS (IOL) AS PER THE DIRECTIONS FOR USE. THE SURGEON WAS ABOUT TO IMPLANT THE IOL INTO THE PATIENT¿S EYE BUT NOTICED A WHITE MARK ON THE LENS. HEALON WAS USED AS A VISCOELASTIC. THERE WAS NO PATIENT INVOLVEMENT/USER INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6986227 ↗
• MalfunctionDec 29, 2016Kinked; Kinked

  THE INTRAOCULAR LENS WAS KINKED/CRIMPED. THE LENS WAS SCRUNCHED UP WHEN ADVANCED, DURING HANDLING BUT PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6213734 ↗