TECNIS IOL PCB00 (REF PCB0000240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 05050474558342), received between Sep 12, 2016 and Oct 19, 2025 — classified as 28 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER BILATERAL IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BILATERAL POSTERIOR CAPSULE OPACIFICATION (PCO) REQUIRING YTTRIUM ALUMINUM GARNET (YAG) SURGICAL INTERVENTION IN 2023. THE YAG PROCEDURE WAS SUCCESSFUL IN THE LEFT EYE (OS). HOWEVER, THE RIGHT EYE (OD), WHILE YAG WAS INITIALLY SUCCESSFUL, REGREW THE EPITHELIAL CELLS ON THE POSTERIOR OF THE IOL A FURTHER TWO TIMES IN 2024 AND 2025, EACH TIMES REQUIRING YAG INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LENS IMPLANTED IN THE RIGHT EYE (OD). A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER EYE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23334036 ↗
• MalfunctionAug 28, 2023Crack; Crack

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) UNIT HAD A FAULTY TIP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637064 ↗
• MalfunctionAug 1, 2023Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) CAME OUT OF THE INJECTOR, THE LENS WAS DAMAGED. THE IOL WAS PARTIALLY INSERTED AND IT WAS REMOVED FROM THE PATIENT'S SURGICAL EYE. ACCOUNT INDICATED THAT DAMAGE FOUND AT INJECTOR EXIT SITE DURING LENS IMPLANTATION LEAD TO THE IOL BEING SCRATCHED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438795 ↗
• MalfunctionJul 19, 2023Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE HAPTICS WERE ADHERING TO THE INTRAOCULAR LENS (IOL). WHEN THE HAPTICS WERE RELEASED, A MARK WAS LEFT ON THE IOL. THROUGH FOLLOW UP WE LEARNED THAT THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. A DELAY IN THE PROCEDURE WAS MENTIONED. THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED. THE SURGEON REPORTED THAT THE HAPTICS EVENTUALLY CAME FREE, BUT SHE STILL HAD TO CUT AND REMOVE THE LENS DUE TO THE MARK LEFT WHERE THE HAPTICS WERE STUCK ON THE OPTICS. NO PATIENT INJURY WAS REPORTED AND NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352698 ↗
• MalfunctionJun 22, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187257 ↗
• MalfunctionApr 12, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT WHILE IMPLANTING THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE CARTRIDGE TIP WAS DAMAGED CAUSING THE LENS TO BE DAMAGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728803 ↗
• MalfunctionMar 16, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS POPPING OUT OF THE INTRODUCER AFTER HAVING BEEN CORRECTLY LOADED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560183 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. ISSUE WAS OBSERVED UPON OPENING THE PACKAGING. DESPITE SEVERAL FOLLOW UPS NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246403 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. ISSUE WAS OBSERVED UPON OPENING THE PACKAGING. DESPITE SEVERAL FOLLOW UPS NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246349 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. ISSUE WAS OBSERVED UPON OPENING THE PACKAGING. DESPITE SEVERAL FOLLOW UPS NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246344 ↗
• MalfunctionApr 21, 2022Contamination; Contamination

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS OBSERVED DURING THE IMPLANTATION WITH AN INTRAOCULAR LENS (IOL). THE FOREIGN MATERIAL WAS EXTRACTED FROM THE EYE CHAMBER. THROUGH FOLLOW-UP, IT WAS LEARNT THAT THE LENS HAD BEEN IMPLANTED WITH NO PROBLEMS. THE PATIENT WILL BE MONITORED FOR ANY PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14179652 ↗
• MalfunctionApr 11, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED DEVICE MALFUNCTIONED AND THE LENS WAS DAMAGED DURING THE CASE. THROUGH FOLLOW UP, THE CUSTOMER EXPLAINED AFTER ADDING BALANCED SALT SOLUTION (BSS) TO THE PRELOADED LENSE CARTRIDGE AS DIRECTED, THEY PROCEEDED TO PUSH THE LENSE FORWARD, BUT THE WHOLE THING WAS SEVERELY STUCK. THEY HAD TO PUT FORCE INTO IT TO MOVE IT AT ALL, AND THE LENSE WAS RUINED. THE SURGEON SAID THAT IT WAS AN INJECTOR MALFUNCTION AND ASKED THAT THEY SEND IT BACK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079849 ↗
• MalfunctionFeb 22, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS INDICATED THAT AFTER HYDRATING THE LENS AND WAIT UNTIL THEY COULD USE IT, WHEN PUSHING THE PLUNGER, THEY FELT THAT THE LENS WAS STUCK IN THE MIDDLE OF THE INJECTOR. THE ACCOUNT REMOVED THE PLUNGER, RE-HYDRATED, WAITED AND THEY PUSHED AGAIN. WHEN ADVANCING AGAIN, THEY SAW HOW THE TIP OF THE PLUNGER BROKE THE LENS. THERE WAS NO CONTACT WITH THE PATIENT'S EYE AS THIS WAS DONE UNDER THE MICROSCOPE BUT WITHOUT PATIENT CONTACT. ANOTHER LENS WAS IMPLANTED AND PATIENT IS IN PERFECT CONDITIONS AND HAPPY WITH THE SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582579 ↗
• MalfunctionJan 15, 2022Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery

  DURING IMPLANTATION, THE LAST PUSH WAS GIVEN AND THE TRAILING HAPTIC WAS NOT FOLDED ONTO THE OPTIC AND INSTEAD UNFOLDED. THE DOCTOR IMPLANTED THE LENS NORMALLY AFTER USING A MAC PHERSON PINCER TO GET THE TRAILING HAPTIC OUT OF THE CARTRIDGE. THE INSERTER IS AVAILABLE WHILE THE LENS REMAINS IMPLANTED. NO DELAY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED AND NO FURTHER DETAILS PROVIDED. THIS EMDR REPORT IS FOR THE SECOND REPORTED EVENT. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262429 ↗
• MalfunctionNov 30, 2021Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC WAS STUCK IN THE SHOOTER AND THE LENS WAS TORN WHEN TRYING TO GET IT OUT. THE LENS HAD TO BE REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE PATIENT DID NOT SUFFER ANY INJURIES AS A RESULT OF THIS EVENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SPARE IOL. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901597 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS IS DEFECTIVE AND WAS THEREFORE NOT IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED DESPITE SEVERAL ATTEMPTS TO OBTAIN MISSING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790150 ↗
• MalfunctionOct 22, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE MALFUNCTIONED DURING LOADING. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT PROVIDED THAT THE LENS WAS STUCK IN THE INJECTOR AND THIS LED TO THE LENS BEING BROKEN. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE SURGEON IMPLANTED A DIFFERENT MODEL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686436 ↗
• InjuryOct 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LENS WAS TORN DURING HANDLING AND WAS REMOVED WITH SUTURES. THERE WAS PATIENT CONTACT AND IT WAS INDICATED THAT THERE WAS A FIVE (5) MINUTE DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580718 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580707 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580696 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOR A PCB00 MODEL INTRAOCULAR LENS(IOL) PHYSICIAN FELT NO RESISTANCE IN LENS DEPLOYMENT BUT ONE ARM (HAPTIC) WAS MISSING. ADDITIONAL DETAILS RECEIVED STATES THAT THE EVENT HAPPENED DURING HANDLING AND PRIOR TO INSERTION OF LENS INTO EYE. THERE WAS NO PATIENT CONTACT AND NO INJURY OR MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF DIFFERENT MODEL BUT SAME DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305725 ↗
• InjuryJul 23, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A PCB00 INTRAOCULAR LENS (IOL), ONE OF THE HANDLES (HAPTIC) STAYED FOLDED IN THE WRONG POSITION AND CAME OUT IN THE Z POSITION. PATIENT WAS PERMANENTLY IMPAIRED. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS 1 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222349 ↗
• MalfunctionJul 15, 2021Crack; Material Protrusion/Extrusion; Crack; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE LENS LOADING CARTRIDGE HAS A "BURR ON THE END OF IT". A BRIEF DESCRIPTION OF THE ISSUE PROVIDED THAT A LITTLE EXTRA PLASTIC/A BUMP THAT WAS NOT SMOOTH AS EXPECTED WAS NOTICED. THE CUSTOMER WAS ABLE TO SUCCESSFULLY IMPLANT THE LENS. THROUGH FOLLOW-UP IT WAS LEARNT THAT THE BURR WAS NOTICED WHEN ENTERING THE INCISION. THERE WERE NO DIFFICULTIES WITH INSERTION. THERE WAS NO NOTICEABLE CHANGE TO THE INCISION. THE PATIENT DIDN¿T REQUIRE SUTURES AND THERE WAS NO NEED FOR VITRECTOMY. THE PATIENT VISUAL ACUITY OUTCOME IS AS EXPECTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178238 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Scratched Material; Break; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) HAD IMPROPERLY LOADED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THE IOL WAS DIFFICULT TO ADVANCE, MAKING A PLASTIC SOUND. WHEN THE IOL WAS CHECKED THERE WAS A MARK LEFT ON THE SIDE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171893 ↗
• InjuryJun 1, 2021Break; Break

  IT WAS REPORTED PRE-LOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS THE HAPTIC WAS BROKEN AND THERE WAS CONTACT WITH THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS BROKEN, DEFECTIVE HAPTIC/OPTIC. UNPLANNED INCISION ENLARGEMENT AND UNPLANNED SUTURE(S) WERE REQUIRED. THERE WAS NO SERIOUS PATIENT INJURY AND NO UNPLANNED VITRECTOMY. PROCEDURE WAS COMPLETED USING A DIFFERENT MODEL (Z9002) LENS WITH A DIFFERENT DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS COMPLETE. IT WAS REPORTED THE LENS IS NOT BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917367 ↗