TECNIS IOL PCB00 (REF PCB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 05050474558335), received between Oct 3, 2016 and Oct 19, 2025 — classified as 33 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 114 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 LEFT EYE (OS). A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER EYE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23334049 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DAMAGED AND COULD NOT BE USED. THE SURGERY WAS STOPPED AND A NEW LENS WAS USED AS A REPLACEMENT. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130366 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF THE PLUNGER BROKEN INTO PIECES. IT WAS REPORTED THAT THE LENS COULD NOT BE IMPLANTED. THROUGH FOLLOW UPS WE LEARNED THAT THERE WAS PATIENT CONTACT WITH THE MATERIAL. ONLY THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THIS DID NOT LEAD TO ANY ADDITIONAL INTERVENTIONS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907163 ↗
• MalfunctionAug 11, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT WHEN INSERTING A PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE LENS SHOT OUT POWERFULLY INTO THE EYE. THIS CAUSED THE PATIENT¿S POSTERIOR BAG TO BE TORN. THE IOL WAS INSERTED AND REMAINS IMPLANTED. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17516017 ↗
• MalfunctionJan 13, 2023Break; Break

  THE PATIENT IMPLANT CARD WAS RECEIVED WITH DOCUMENTED VERBIAGE STATING DEFECT, NOT USED CRACKED IN CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162484 ↗
• MalfunctionJan 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS INJECTED WITHIN THE PATIENT'S OPERATIVE EYE IT ONLY HAD ONE HAPTIC. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126222 ↗
• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900856 ↗
• MalfunctionOct 21, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS FAULTY. FURTHER FOLLOW-UP REVEALED THAT THE HAPTIC WAS DAMAGED IN THE INSERTER. THE PROCEDURE WAS COMPLETED WITH A BACK UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655313 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED THAT PRELOADED THE PCB00 INTRAOCULAR LENS (IOL) WAS DAMAGED. THERE IS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238104 ↗
• MalfunctionJun 15, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO EYE, THERE WAS A WHITE FOREIGN MATTER IN THE EYE. THE FOREIGN MATTER WAS REMOVED AND DISCARDED. IOL REMAINS IMPLANTED. NO ADVERSE EFFECT ON PATIENT. IT WAS INDICATED THAT DUE TO THE EMERGENCY SITUATION AT THAT TIME, THE SURGEON WAS EAGER TO IMPLANT THE LENS FOR THE PATIENT ON THE TABLE AND DID NOT NOTICE OR CHECK IF THERE WAS ANY DEBRIS OR FOREIGN BODY ON THE PCB00. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692232 ↗
• MalfunctionJun 14, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING IMPLANTATION, THE SURGEON WAS UNABLE TO ADVANCE INTRAOCULAR LENS (IOL) AS IT WAS DIFFICULT TO ADVANCE. IOL WAS MANAGED TO BE IMPLANTED INTO THE EYE, HOWEVER, THE HAPTIC WAS OBSERVED BROKEN. IOL WAS REMOVED AND REPLACED. NO ADVERSE EFFECT TO THE PATIENT. PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691407 ↗
• MalfunctionMar 8, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER PERFORMING A PERFECTLY INTRAOCULAR LENS (IOL) IMPLANT, THE IOL WENT IN WITH A WHITE PIECE. THE PIECE WAS REMOVED WITH THE IRRIGATION AND ASPIRATION CANNULA. THERE WAS NO WOUND ENLARGEMENT. AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691373 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OPENED ON STERILED FIELD. THE SURGEON WAS HANDED THE IOL AND NOTICED THE LENS WAS CRUNCHED UP. THE SURGEON ASKED FOR A NEW LENS. THE INCIDENT OCCURRED DURING PRODUCT HANDLING AND PRIOR TO PATIENT CONTACT. THE PATIENT WAS FULLY RECOVERED. THE LENS WAS DISCARDED AND NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13555538 ↗
• MalfunctionFeb 3, 2022Break; Crack; Device Difficult to Setup or Prepare; Break; Crack; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRINKLED. THE TECHNICIAN AND THE SURGEON COULD NOT GET THE LENS TO PUSH THROUGH THE SYRINGE AND WHEN IT FINALLY CAME OUT, IT POPPED OUT OF THE SIDE, CAUSING THE LENS TO BE BENT OR DAMAGED. THE LENS WAS NOT USABLE. THERE WAS NO PATIENT CONTACT WITH THE LENS/ DEVICE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447589 ↗
• MalfunctionDec 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A CUSTOMER COMPLAINED THAT A LENS COULDN'T COMPLETELY BE PUSHED OUT OF THE SHOOTER. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/ APPLICATION. THE LENS FULLY IMPLANTED, BUT THE SURGEON NOTICED THERE WAS ONLY ONE HAPTIC AND THEREFORE REMOVED THE LENS DURING THE SAME PROCEDURE. THE INCISION NEEDED TO BE ENLARGED. THE SURGERY WAS COMPLETED USING A NEW LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (24.0) AND REPORTEDLY, THE PATIENT IS OK. IT WAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914944 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC TWISTED. THE NURSE CANNOT REMEMBER IF THERE WAS PATIENT CONTACT. ANOTHER LENS WAS USED AND THE PATIENT'S OPERATION WAS COMPLETED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807098 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC TWISTED. THE NURSE CANNOT REMEMBER IF THERE WAS PATIENT CONTACT. ANOTHER LENS WAS USED AND THE PATIENT'S OPERATION WAS COMPLETED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806996 ↗
• MalfunctionSep 28, 2021Inaccurate Delivery; Operating System Becomes Nonfunctional; Inaccurate Delivery; Operating System Becomes Nonfunctional

  ON (B)(6) 2021, THE CUSTOMER FILLED THE INJECTOR WITH HEALON AND PUSHED IT OUT TO THE FIRST MARK SHORTLY BEFORE THE IMPLANTATION ACCORDING TO NORMAL PROCEDURE. THEN IT WAS FOUND THAT THE PLUNGER DID NOT ENGAGE. THE THREAD DID NOT GRIP AND THE LENS SLID OUT OF THE INJECTOR IN AN UNCONTROLLED FASHION. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544729 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT THE PCB00 MODEL INTRAOCULAR LENS (IOL) WAS FAULTY. THROUGH FOLLOW-UP IT WAS LEARNT THAT THE HAPTICS DID NOT COME UP FROM THE CARTRIDGE; THE CARTRIDGE TIP WAS IN CONTACT WITH THE PATIENT'S EYE; HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12400577 ↗
• MalfunctionAug 18, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT COME OUT OF THE CARTRIDGE AS THEY SHOULD, BREAKING THE HANDLES. THE LENSES COULD NOT BE IMPLANTED AND WERE REPLACED BY OTHERS OF THE SAME MODEL. THERE WAS A DELAY IN TREATMENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339786 ↗
• MalfunctionJul 15, 2021Crack; Material Too Rigid or Stiff; Crack; Material Too Rigid or Stiff

  IT WAS REPORTED THAT WHEN THE NURSE PUSHED THE PLUNGER FORWARD THEY NOTICED THE PRELOADED LENS WAS HARDER AND SLOWER TO PUSH FORWARD COMPARED TO OTHER PRELOADED LENSES THAT DID NOT PRESENT WITH ANY ISSUE AS ALL WENT WELL. THE SURGEON LATER TRIED TO IMPLANT THE LENS AND NOTICED THAT THE TIP OF THE PLUNGER ALMOST PUSHED THRU THE CARTRIDGE. THE DOCTOR STOPPED THE IMPLANTATION AND OPENED A NEW LENS WHICH WAS SUCCESSFULLY IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176220 ↗
• MalfunctionJul 15, 2021Break; Device Contaminated During Manufacture or Shipping; Scratched Material; Break; Device Contaminated During Manufacture or Shipping; Scratched Material

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE/SCRATCHED AND THERE WAS DEBRIS ON THE IOL. THE ISSUE WAS NOTICED PRIOR TO PATIENT CONTACT AND THE IOL WAS NOT INSERTED. THERE IS NO INDICATION OF INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174875 ↗
• MalfunctionJul 9, 2021Crack; Material Too Rigid or Stiff; Crack; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE TWISTING PART OF THE DEPLOYMENT WAS STIFF AND AS THE ROD ADVANCED IT APPEARED TO COME OUT OF THE SIDE OF THE CARTRIDGE TIP. A SECOND LENS WAS USED WITHOUT ANY COMPLICATIONS. PRODUCT INVESTIGATION AS PER (B)(6) 2021 CONFIRMS THAT THE DAMAGE OF THE CARTRIDGE WAS AT THE TIP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145370 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE. THE SURGERY WENT SMOOTHLY. POSTOPERATIVE EYE DROPS WERE ROUTINELY PERFORMED. ONE DAY AFTER OPERATION, RE-EXAMINATION SHOWED VISUAL ACUITY OF 0.6 IN THE RIGHT EYE, CONJUNCTIVAL CONGESTION, CORNEAL DETUMESCENCE, DEEP ANTERIOR CHAMBER, TYN (TYNDALL) (+), AND INTRAOCULAR LENS POSITION. THE OTHER EXAMINATION CONDITIONS WERE THE SAME AS ADMISSION, WITH INTRAOCULAR PRESSURE OF 17.7 MMHG. SUSPECTED BODY REACTION TO THE IOL IN THE EYE. THE PATIENT WAS GIVEN PREDNISOLONE ACETATE EYE DROPS 0.02ML TID (THREE TIMES A DAY) IN THE RIGHT EYE, TOBRAMYCIN EYE DROPS 0.02ML TID IN THE RIGHT EYE, AND COMPOUND TROPICAMIDE EYE DROPS 0.02ML TID IN THE RIGHT EYE FOR SYMPTOMATIC TREATMENT. ON (B)(6) 2021, THE PATIENT RETURNED TO THE HOSPITAL FOR RE-EXAMINATION: RIGHT EYE 0.6, CONJUNCTIVAL CONGESTION, CORNEAL DETUMESCENCE, ANTERIOR CHAMBER DEPTH, TYN (-), PUPIL DIAMETER ABOUT 3 MM, INTRAOCULAR LENS POSITION POSITIVE, THE OTHER EXAMINATION CONDITIONS WERE THE SAME AS BEFORE, INTRAOCULAR PRESSURE 16.3 MMHG, THE PATIENT WAS GIVEN PREDNISOLONE ACETATE EYE DROPS 6 TIMES/DAY IN THE RIGHT EYE AND TO

  Patient problems: Chemosis; Corneal Edema; Discomfort

  MAUDE report 11874815 ↗
• MalfunctionMay 17, 2021Break; Break

  IT HAS BEEN REPORTED ISSUES WITH A PCB00. DEFECTIVE AS THE INTRAOCULAR LENS (IOL) LEGS CAME OUT BADLY. NO CONTACT WITH PATIENT'S EYE, THE ISSUE WAS NOTICED AT FIRST DURING HANDLING BUT PRIOR INSERTION. NO PATIENT INVOLVEMENT REPORTED. MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. CUSTOMER HAS NO FURTHER INFORMATION THAN WHAT HAS BEEN PROVIDED IN THIS FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11834233 ↗