TECNIS IOL PCB00 (REF PCB0000145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474558151), received between Oct 25, 2016 and Jun 19, 2023 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT WHEN ATTEMPTING TO IMPLANT THE PRELOADED INTRAOCULAR LENS (IOL) IN THE RIGHT EYE, THE DEVICE GOT STUCK AND WOULD NOT COME OUT OF THE CARTRIDGE. THE PLUNGER "REACHES THE TOP OF ITS TRAVEL" AND DID NOT EJECT THE LENS, WHICH GOT STUCK INSIDE THE CARTRIDGE. THE SURGEON OPENED THE DISPOSABLE INJECTOR AND MANAGED TO REMOVE THE LENS FROM THE CARTRIDGE. UPON REVIEW OF THE LENS UNDER THE MICROSCOPE, THE SURGEON REALIZED THAT ONE OF THE HAPTICS WAS DAMAGED, REMAINING SEPARATED FROM THE OPTICAL BODY OF THE LENS, THEREFORE THE LENS WAS UNABLE TO BE USED AND THE SURGEON IMPLANTED A NON-JOHNSON AND JOHNSON IOL IN THE RIGHT EYE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159449 ↗
• MalfunctionMar 25, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PCB00 LENS DURING SURGERY DID NOT HAVE THE SECOND HAPTIC WHEN IMPLANTED INTO THE PATIENTS' EYE. LENS WAS IMPLANTED AND REMOVED AFTER THAT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571764 ↗
• MalfunctionDec 7, 2020Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER IDENTIFIED A LENS WITH A SMALL BURR / WIRE OR SIMILAR ON IT. DR. (B)(6) GOT THE PIECE OFF WITH FORCEPS WITHOUT ANY COMPLICATIONS, BUT IT WAS CLEAR THAT THE WIRE / PIECE WAS REALLY ATTACHED TO THE LENS AS IF PART OF IT. THE LENS MOVED AS HE PULLED THE PIECE. NO PATIENT INJURIES WERE CAUSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10962878 ↗
• InjuryOct 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN IT HAD TO BE REMOVED FROM THE PATIENT'S RIGHT (OD) EYE FOR STABILITY REASONS. EVENT WAS NOTICED AFTER THE LENS INSERTION. NO OTHER LENS WAS IMPLANTED, BUT VITRECTOMY WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS DOING OK. THE CUSTOMER INDICATED THAT THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10659319 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BEEN IMPLANTED WITH PRELOADED INTRAOCULAR LENS AND HE IS EXPERIENCING CLOUDY VISION AS IF A CURTAIN IS MOVING AROUND HIS EYE. REPORTEDLY HIS VISION WAS FINE FIRST TWO DAYS POST-SURGERY, HOWEVER THIRD DAY HIS VISION WAS FUZZY. SURGEON STATED IT IS NORMAL AND WILL FADE AWAY. SURGEON PRESCRIBED HIM EYE DROPS TO TAKE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Clouding/Hazing; No Code Available

  MAUDE report 9558182 ↗
• MalfunctionDec 26, 2019Failure to Fold; Failure to Eject; Failure to Fold; Failure to Eject

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF AN INTRAOCULAR LENS, MODEL PCB00 CAME OUT FIRST FROM THE CARTRIDGE DURING A CATARACT SURGERY. ISSUE OBSERVED DURING INSERTION. AS PER FOLLOW-UP WAS LEARNED THAT THE LENS WAS STUCK IN CARTRIDGE. NO PATIENT INJURY REPORTED. ALL THE INFORMATION AVAILABLE WERE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520963 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT COULD NOT ADJUST TO SINGLE VISION. REPORTEDLY, PATIENT IS DOING FINE POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9139115 ↗
• InjuryAug 5, 2019Break; Break

  IT WAS REPORTED THAT TRAILING HAPTIC WAS MISSING UPON IMPLANTATION. LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. REPORTEDLY LEADING HAPTIC WAS BROKEN. THE SURGEON STATED THAT HAPTIC OPTIC IS SIGNIFICANTLY DIFFERENT. LENS WAS CUT USING VANESSA SCISSORS. THERE WAS 8-10 MINUTES OF DELAY IN THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8860050 ↗
• MalfunctionJun 28, 2019Break; Failure to Unfold or Unwrap; Separation Problem; Break; Failure to Unfold or Unwrap; Separation Problem

  IT WAS REPORTED THAT A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) HAD AN UNFOLDING ISSUE AND MISSING COMPONENT (MISSING A HAPTIC). THERE WAS NO PATIENT CONTACT REPORTED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8743025 ↗
• MalfunctionApr 16, 2019Contamination; Contamination

  IT WAS REPORTED THAT A SMALL THREAD CAME OUT OF THE PRELOADED DELIVERY SYSTEM DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL). REPORTEDLY, THE LENS REMAINS IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517519 ↗
• MalfunctionJul 13, 2018Difficult or Delayed Positioning; Physical Resistance/Sticking; Difficult or Delayed Positioning; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (PCB00 14.5 DIOPTER) THE HAPTIC GOT STUCK IN THE CARTRIDGE. REPORTEDLY, THE LENS HAD PATIENT CONTACT BUT THERE WAS NO INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7685088 ↗
• MalfunctionDec 20, 2017Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT THE DOCTOR COULDN'T INSERT A PCB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE EYE. REPORTEDLY, THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136524 ↗
• InjuryApr 2, 2017Material Opacification; Material Opacification

  A REPORT WAS RECEIVED FROM A FEMALE PATIENT WHO HAD A MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTED IN HER LEFT EYE. AFTER THE SURGERY THE PATIENT EXPERIENCED REMARKABLE AND CONTINUOUS PROBLEMS WITH HER VISION. REPORTEDLY, THE PATIENT WENT TO A SECOND PHYSICIAN WHO OBSERVED A CENTRAL OPALESCENT AREA ON THE LENS AND A SMALL CENTRAL POSTERIOR CAPSULAR OPACITY (PCO) IN THE LEFT EYE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT WAS VISITED AGAIN BY THE OPERATING SURGEON, WHO DIDN¿T OBSERVE ANY ISSUES WITH THE LENS. THE PATIENT WAS THEN VISITED BY A THIRD PHYSICIAN WHO DIDN'T FIND ANY PROBLEMS WITH THE LENS EITHER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6452027 ↗
• MalfunctionMar 20, 2017Sticking; Sticking

  IT WAS REPORTED THAT AFTER THE INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE HAPTIC WAS STUCK UNDERNEATH THE OPTIC. NO PATIENT INJURY AND NO INCISION ENLARGEMENT WAS REPORTED. REPORTEDLY, THE LENS REMAINED IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6416479 ↗
• MalfunctionDec 15, 2016Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  THE INTRAOCULAR LENS (IOL) WOULD NOT COME OUT OF THE CARTRIDGE COMPLETELY. THE LENS HAD PARTIAL CONTACT WITH THE EYE. IT WAS NOT FULLY INSERTED AS THE LENS WAS PARTLY STUCK. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE AND NO VITRECTOMY. A BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT IS FINE. THERE WERE NO INFECTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6176327 ↗
• MalfunctionOct 25, 2016Positioning Failure; Split; Positioning Failure; Split

  IT WAS REPORTED THAT THE TIP OF THE INJECTOR (CARTRIDGE) SPLIT DURING THE DEPLOYMENT OF AN INTRAOCULAR LENS (IOL). REPORTEDLY THE LENS WAS PREPARED AS PER INSTRUCTION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THE SAME ISSUE HAPPENED IN THREE OCCASIONS, DURING THE MORNING LIST, WITH A NEW SURGEON. ON THE FIRST OCCASION THE SURGEON REMOVED THE COVER AND DURING INSERTION REALISED THAT THE LENS DID NOT COME OUT OF THE TIP OF THE CARTRIDGE AND THE TIP HAD SPLIT. A NEW LENS WAS USED WITHOUT ANY PROBLEMS. THE FURTHER TWO OCCASIONS, THE SURGEON INSPECTED THE DELIVERY SYSTEM UNDER THE MICROSCOPE PRIOR TO INSERTING INTO THE PATIENT'S EYE AND FOUND THAT THE CARTRIDGE'S TIP WAS SPLIT. AGAIN NEW LENSES WERE USED. THE SURGEON BELIEVED THAT THE PLUNGER WAS PUSHING FROM THE SIDE, MISSING THE LENS, AND CAUSING THE LENS TO TWIST AROUND RATHER THAN PUSHING THE LENS STRAIGHT. REPORTEDLY IT WAS ALSO BELIEVED THAT ADEQUATE VISCOELASTIC HELON WAS USED EACH TIME. NO FURTHER INFORMATION WAS PROVIDED. THREE PRELOADED DELIVERY SYSTEM MODEL PCB00 WERE REPORTED, THEREFORE THREE MDRS WILL BE FILED. THIS MDR IS FOR SERIAL NUMBER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6052970 ↗