TECNIS IOL PCB00 (REF PCB0000140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474558144), received between Nov 20, 2016 and Jun 1, 2022 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 21, 2018Terminated

   Expired intraocular lenses were distributed.

   Z-0464-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAULTY INTRAOCULAR LENS (IOL). THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569848 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAULTY INTRAOCULAR LENS (IOL). THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569811 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAULTY INTRAOCULAR LENS (IOL). THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569805 ↗
• MalfunctionJul 30, 2021Break; Break

  CUSTOMER REPORTED THAT THE LENS WAS DAMAGED AND ADDED THAT IT WAS DEFECTIVE. ADDITIONALLY, THERE WAS NO PATIENT CONTACT. FOLLOW-UP WAS DONE TO GET ADDITIONAL DETAILS BUT THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256722 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS INITIALLY REPORTED THAT THE INSERTER AMPUTATES THE HAPTIC IN THE PRELOADED PCB00 INTRAOCULAR LENSES AND CUSTOMER ASKED TO EXCHANGE THEM FOR ZCBS. ADDITIONAL INFORMATION STATES LENS HAD PINCHING ISSUES OF THE TRAILING HAPTICS BUT WAS INSERTED INTO THE PATIENTS EYE WITH NO PROBLEM. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750236 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED ISSUES WITH A MODEL PCB00 INTRAOCULAR LENS (IOL). THE LENS GOT DAMAGED DURING HANDLING BUT PRIOR INSERTION INTO THE PATIENT'S EYE. NO CONTACT WITH PATIENT'S EYE, THE LENS IS NOT BIOLOGICALLY CONTAMINATED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742473 ↗
• MalfunctionApr 7, 2021Material Fragmentation; Failure to Advance; Material Fragmentation; Failure to Advance

  IT WAS REPORTED THAT PRELOADED LENS (IOL) HAPTICS WERE SHEARED OFF UPON ADVANCEMENT INTO EYE, HALF OF LENS WAS STILL IN INJECTOR. THE LENS TOUCHED THE PATIENT EYE. THERE WAS REMOVAL AND REPLACEMENT, NO INCISION. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628938 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS DAMAGED WHEN PRIMING. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11234838 ↗
• MalfunctionOct 21, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF INSERTER TOO QUICKLY DURING INSERTION. IT WAS NOTED ONLY THE INSERTER TIP TOUCHED THE PATIENT'S EYE. A DIFFERENT LENS WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING FINE POST-SURGERY. THE CUSTOMER INDICATED THAT THE LENS WAS DISPOSED, AND ONLY THE INSERTER IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10709462 ↗
• MalfunctionMar 23, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL PCB00 14.0 DIOPTER) WAS NOT UNFOLDED PROPERLY IN THE EYE OF THE PATIENT. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9867928 ↗
• InjuryJan 25, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WOULD NOT POSITION IN THE CAPSULE OF THE PATIENTS RIGHT EYE. A SULCUS LENS WAS REQUIRED AND AN INCISION ENLARGEMENT WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LENS KEPT MOVING NASALLY BUT IT IS UNKNOWN WHY IT WOULD NOT CENTER. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9630207 ↗
• MalfunctionDec 17, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENTS RIGHT AND WOULD NOT ADVANCE FROM THE INSERTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9485264 ↗
• InjuryJul 8, 2019Break; Break

  IT WAS REPORTED THAT THE IOL BROKE DURING INSERTION INTO THE PATIENT¿S OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE REQUIRING INCISION ENLARGEMENT, AND SUTURES. THERE WAS A 10-MINUTE DELAY, BUT NO INJURY REPORTED. PATIENT OUTCOME IS NOTED AS NORMAL. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8769984 ↗
• MalfunctionMay 10, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS HAD UNFOLDING ISSUES. THE LENS WAS IMPLANTED, REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. ANOTHER LENS WITH SAME MODEL AND SAME DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8598293 ↗
• InjuryMay 7, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON OBSERVED ONCE IMPLANTED A MODEL PCB00 INTRAOCULAR LENS (IOL), THAT THE TRAILING HAPTIC WAS MISSING. AN INCISION ENLARGEMENT WAS REQUIRED, AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME TYPE. THE PATIENT'S OUTCOME WAS GOOD, AND NO POST-OPERATIVE COMPLICATIONS RELATED TO THE BROKEN HAPTIC WERE REPORTED. THE DAMAGED LENS WAS NOTED AS DISCARDED AND NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8589196 ↗
• MalfunctionApr 19, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED WHILE ATTEMPTING TO INSERT PCB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) THE LENS WOULD NOT DEPLOY, STUCK IN THE PRE-LOADED CARTRIDGE, AND THERE WAS PATIENT CONTACT WITH THE PRODUCT. IT WAS REPORTED THE LENS WAS DISCARDED, OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530466 ↗
• MalfunctionOct 1, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00 +14.0 DIOPTER), THE PHYSICIAN NOTICED THAT THE LENS WAS MARKED AND IT WAS NECESSARY TO REMOVE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921615 ↗
• InjuryAug 27, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT WRONG SIZE LENS (PCB00 +14.0 DIOPTER) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD). PER ACCOUNT, THE DOCTOR WENT TO DICTATE AND NOTED WRONG LENS IMPLANTED. CONSEQUENTLY, LENS HAD TO BE REMOVED AND REPLACED DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS PERFORMED. THE PATIENT RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7815912 ↗
• MalfunctionJul 25, 2018Difficult or Delayed Positioning; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Difficult or Delayed Positioning; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00) THE DOCTOR PUSHED THE PLUNGER OF THE INJECTOR AND STARTED SCREWING AS REQUIRED. REPORTEDLY, THE LENS GOT STUCK BETWEEN THE CARTRIDGE AND THE PLUNGER. THE SURGEON HAD TO TAKE A MCPHERSON PINCET TO RELEASE THE TRAILING HAPTIC OUT OF THE CARTRIDGE. NO PATIENT INJURY AND NO WOUND ENLARGEMENT WAS REQUIRED. THE ACCOUNT COMMENTED THAT THE TRAILING HAPTIC WAS PARTIALLY UNFOLDED WHILE STILL IN THE CARTRIDGE WHICH CAUSED IT TO GET STUCK. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CLARIFIED THAT THE LEADING HAPTIC AND THE LENS OPTIC WERE RELEASED NORMALLY BUT THE TRAILING HAPTIC WAS PARTIALLY UNFOLDED AND GOT STUCK IN THE CARTRIDGE. THE TRAILING HAPTIC WAS THEN MANUALLY RELEASED AND THE PROCEDURE COULD BE FINISHED WITHOUT ANY ADVERSE EFFECTS FOR THE PATIENT. THE DELIVERY SYSTEM WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719173 ↗
• MalfunctionMay 31, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON PREPARING FOR INSERTION, THE DOCTOR NOTICED THAT THE TIP OF THE PCB00 INSERTER SHOWED AN ABNORMAL SHAPE. UNDER THE SURGICAL MICROSCOPE, IT WAS CONFIRMED THAT THE TOP EDGE OF THE TIP WAS BLUNT AS IF IT WAS CRUSHED. THERE WAS NO MISUSE OR WRONG MANIPULATION BY THE SCRUB NURSE NOR SURGEON. THE PACKAGING OF LENS WAS INTACT. ANOTHER LENS WAS USED TO IMPLANT AND THE SUSPECTED DEFECTIVE LENS WAS DISCARDED. THERE WAS NO ADVERSE EVENT FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Patient Involvement

  MAUDE report 7559367 ↗
• MalfunctionMay 23, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT A PCB00 14.0 DIOPTER LENS EJECTED PREMATURELY INTO THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7539673 ↗
• MalfunctionApr 22, 2018Bent; Crack; Bent; Crack

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) CARTRIDGE TIP WAS DAMAGED OR BENT DURING HANDLING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7449858 ↗
• MalfunctionSep 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT RINGS (LATHE LINES) WERE EVIDENT ON AN INTRAOCULAR LENS (IOL). IOL REMAINS IMPLANTED. THE PATIENT IS WELL. THERE IS NO AFFECT ON THE PATIENT'S DAILY ACTIVITIES. NO INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6844032 ↗
• MalfunctionSep 5, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PCB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE AND WAS PARTIALLY DELIVERED INTO THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY AND THE LENS WAS NOT FULLY IMPLANTED. A BACK UP LENS WAS USED WITH NO ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843955 ↗
• MalfunctionJul 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE SURGEON REPORTED THAT THERE WERE WHITE DEPOSITS CENTRALLY ON THE POSTERIOR SIDE OF THE INTRAOCULAR LENS (IOL). THE PATIENT IS NOT COMPLAINING AT THIS TIME. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6739241 ↗