TECNIS IOL PCB00 (REF PCB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 05050474558311), received between Sep 1, 2016 and Jan 8, 2024 — classified as 31 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT WHEN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THERE WAS A CRACK. IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466443 ↗
• 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 17438793 ↗
• MalfunctionJun 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A FOREIGN BODY OR BIT OF PLASTIC ATTACHED TO THE INTRAOCULAR LENS (IOL). IT WAS CONFIRMED THROUGH FOLLOW UP THAT THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222154 ↗
• MalfunctionNov 23, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED A SCRATCH ON THE PRELOADED INTRAOCULAR LENS (IOL) ONCE IT WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE. THE LENS WAS THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL (SAME MODEL AND DIOPTER) IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859087 ↗
• MalfunctionAug 31, 2022Break; Mechanical Problem; Break; Mechanical Problem

  CUSTOMER REPORTED THAT THE PLUNGER WENT STRAIGHT THROUGH THE TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) . THE PHYSICIAN RETRACTED THE PLUNGER, PUT MORE METHYL AND MANAGED TO GET THE PLUNGER TO TAKE THE LENS. PHYSICIAN TOOK THE IOL OUT TO SEE IF IT WAS INTACT. PHYSICIAN WOULD USE A PLATINUM CARTRIDGE TO PERFORM THE IMPLANT, BUT THE LENS HAD A MALFUNCTION (CRACKED OR SCRATCHED) IN THE OPTICAL ZONE. THERE WAS NO PATIENT CONTACT AND ISSUE OCCURRED DURING HANDLING/PRIOR TO INSERTION. DUE TO WHAT HAPPENED, THERE WAS AN INCREASE IN THE SURGICAL TIME. IT WAS NECESSARY TO OPEN ANOTHER LENS (THE SAME DEGREE OF LENS WAS AVAILABLE AT THE CLINIC). DESPITE THE INCREASE IN SURGICAL TIME, THE PATIENT WAS NOT AFFECTED BECAUSE A NEW LENS WAS IMPLANTED. PATIENT FULLY RECOVERED. PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. MEDICATION WAS PRESCRIBED FOR STANDARD POSTOPERATIVE USE. PATIENT DID NOT SEEK MEDICAL ATTENTION. NO SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325725 ↗
• MalfunctionJun 17, 2022Break; Break

  THE ACCOUNT REPORTED FAULTY LENS WITH AN INTRAOCULAR LENS (IOL). THE ISSUE WAS IDENTIFIED DURING HANDLING/PRIOR TO INSERTION WITH NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739530 ↗
• MalfunctionMay 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, IT WAS MISSING A HAPTIC. THE IOL WAS REMOVED AND REPLACED. THIS CAUSED A DELAY TO THE SURGERY TIME. IT WAS ALSO MENTIONED THAT INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14387979 ↗
• InjuryMay 3, 2022Mechanical Problem; Material Too Rigid or Stiff; Mechanical Problem; Material Too Rigid or Stiff

  CORRESPONDENCE WAS RECEIVED INDICATING THAT THE PLUNGER WAS STIFF AND OVERRODE THE IOL(INTRAOCULAR LENS), THAT THERE WAS ONE CLICK, AND THAT SUTURES WERE REQUIRED. THERE WAS NO DELAY IN PROCEDURE REPORTED. NO MEDICAL INTERVENTION, NO INCISION ENLARGEMENT AND NO VITRECTOMY REPORTED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14265921 ↗
• InjuryApr 26, 2022Device Difficult to Setup or Prepare; Inaccurate Delivery; Device Difficult to Setup or Prepare; Inaccurate Delivery

  CUSTOMER REPORTED AN ISSUE WHEN IMPLANTING A PRELOADED INTRAOCULAR LENS (IOL), MODEL PCB00. A BRIEF DESCRIPTION OF THE EVENT PROVIDED THAT THE PHYSICIAN NOTICED THAT THE INJECTOR WAS HARDER THAN NORMAL AND THE LENS WALKED ON THE PLUNGER WITH DIFFICULTY. SUDDENLY, PHYSICIAN FELT A SMALL TREMOR AND THE LENS STAYED ON THE TIP OF THE INJECTOR WITHOUT ENTERING THE ANTERIOR CHAMBER. PHYSICIAN NOTICED THAT IN THIS TREMOR, THE POSTERIOR CAPSULE WAS RUPTURED DURING THE ATTEMPT TO IMPLANT THE IOL. PHYSICIAN WAS UNABLE TO IMPLANT THE COMBINED LENS WITH THE PATIENT AND HAD TO ENLARGE THE INCISION TO IMPLANT A RIGID LENS IN THE CAPSULAR SULCUS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 14214952 ↗
• MalfunctionApr 11, 2022Inaccurate Delivery; Mechanical Jam; Operating System Becomes Nonfunctional; Inaccurate Delivery; Mechanical Jam; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE SCREW MECHANISM OF THE INTRAOCULAR LENS (IOL) DIDN'T WORK AND THE LENS GOT STUCK IN THE TIP. THE SURGEON MANAGED TO PULL THE LENS OUT OF THE TIP AND IMPLANTED IT THIS WAY. THERE WAS NO HARM TO THE PATIENT AND THEY DID NOT HAVE ANY COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079494 ↗
• MalfunctionMar 15, 2022Break; Mechanical Jam; Break; Mechanical Jam

  CUSTOMER REPORTED LENS DID NOT COME OUT IT REMAINED STUCK IN THE INJECTOR AND DAMAGED THE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13767503 ↗
• MalfunctionDec 27, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance

  IT WAS REPORTED THAT AFTER IMPLANTATION ACCORDING TO THE DFU (DIRECTIONS FOR USE), THE LAST PUSH WAS GIVEN AND THE TRAILING HAPTIC UNFOLDED AND STAYED IN THE CARTRIDGE. THE HAPTIC WAS NOT FOLDED ON THE OPTIC OF THE LENS AND THE DOCTORS GOT IT OUT OF THE CARTRIDGE WITHOUT DAMAGE, REQUIRING A SECONDARY TOOL TO FREE THE LENS. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO PATIENT ISSUES REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091092 ↗
• MalfunctionDec 23, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FAULTY AS THE HAPTIC WAS TURNING THE WRONG WAY AT THE TIP OF THE PRELOADED DEVICE. CUSTOMER WAS NOT ABLE TO USE THE IOL FOR SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079332 ↗
• MalfunctionOct 25, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PIECE OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN OFF WHEN IT WAS ADVANCED THROUGH THE LOADER. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT IT WAS THE TRAILING HAPTIC THAT BROKE OFF. THERE WAS NO PATIENT CONTACT. ANOTHER LENS OF DIFFERENT MODEL (DCB00), BUT SAME DIOPTER WAS USED AS THE REPLACEMENT LENS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694393 ↗
• MalfunctionOct 24, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CUSTOMER REPORTED LENS DAMAGED AND STUCK IN CARTRIDGE WITH A MODEL PCB00 TECNIS ITEC PRELOADED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686773 ↗
• MalfunctionSep 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED THAT THEIR TECNIS ITEC PCB0000225 LENS TORE DURING THE IMPLANT. LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478667 ↗
• MalfunctionJul 30, 2021Break; Failure to Advance; Break; Failure to Advance

  IT HAS BEEN REPORTED ON AN ISSUE THAT A CUSTOMER HAD A LENS DEFECTIVE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256300 ↗
• 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 7 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222355 ↗
• 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 4 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222352 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) MODEL PCB00, THE PATIENT COMPLAINED ABOUT ITCHY EYES JUST AFTER THE SURGERY IN 2019. HOWEVER, THE ITCH WAS MINOR AND NOW IT'S SEVERE. IT HAS BEEN SEVERE FOR THE LAST 3 MONTHS, HER MAIN ITCH IS INSIDE HER EYE IN THE SOCKET, AND FEELS LIKE SHE WANTS TO SCRATCH HER EYES OUT. SHE HAS LITTLE BUMPS THAT HAVE COME UP ON HER FOREHEAD. SHE HAS TRIED DIFFERENT EYE DROPS, AND THEY DON'T WORK. SHE HAS SEEN ABOUT 4 DIFFERENT DOCTORS AND AN ALLERGIST ABOUT THIS ISSUE, SHE STATES THEY WANT TO TELL HER SHE IS ALLERGIC BUT THEY JUST GIVE HER DROPS & STEROIDS BUT IT DOES NOT TAKE CARE OF THE PROBLEM. ONE DOCTOR TOLD HER SHE COULD NOT BE ALLERGIC TO THE IOL. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Red Eye(s)

  MAUDE report 12222341 ↗
• InjuryJul 21, 2021Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT WHILE IMPLANTING THE INTRAOCULAR LENS (IOL) IT WAS A BIT STICKY. WHEN THE LENS WAS IN THE EYE AND STARTED TO UNFOLD THE TRAILING HAPTIC WAS FOUND TO BE TORN. THE WOUND WAS ENLARGED AND THE LENS EXTRACTED IMMEDIATELY. DUE TO LOW ANTERIOR CHAMBER THERE WAS SOME LEAKAGE AND IRIS PROLAPSE. AFTER THE LEAKAGE SETTLED AND PROLAPSE WAS MANAGED AND THE EYE WAS FLUSHED CLEAR, A NEW LENS WAS IMPLANTED. AFTER THE OPERATION THERE WAS AN EDEMA IN THE CORNEA AND THE INTRA-OCULAR PRESSURE (IOP) WAS ELEVATED. THE LENS IS NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Prolapse

  MAUDE report 12207667 ↗
• MalfunctionJul 15, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED WRONG DIOPTER AND THE INTRAOCULAR LENS (IOL) WAS SWITCHED. THERE WAS PATIENT CONTACT. THE IOL WAS DISCARDED BY THE CUSTOMER. THROUGH FOLLOW UP THE CUSTOMER EXPLAINED THERE WAS NO PACKAGING ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178616 ↗
• InjuryJun 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOTICED TO HAVE MISSING HAPTIC. THE LENS WAS FULLY INSERTED INTO PATIENT'S LEFT EYE AND WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS PATIENT INJURY THAT PATIENT HAD +2 CORNEAL EDEMA, SEEING 21/50. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Corneal Edema

  MAUDE report 11942507 ↗
• MalfunctionMay 26, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT A PRELOADED PRODUCT WAS USED BUT THERE WAS A PROBLEM WITH THE INJECTOR AND THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS STATED THAT THE IOL DID NOT TOUCH THE PATIENT'S LEFT EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891317 ↗
• MalfunctionMay 17, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE LEGS OF THE LENS BROKE AT TIME OF INJECTION. ANOTHER LENS WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT. MATERIAL IS AVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838613 ↗