TECNIS IOL PCB00 (REF PCB0000200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 05050474558267), received between Sep 2, 2016 and Nov 24, 2025 — classified as 37 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT THE LENS WAS BROKEN WHEN INJECTING DUE TO THE JAMMED PUSH ROD. THE SURGEON IMMEDIATELY DISCONTINUED THE SURGERY, REMOVED THE BROKEN LENS AND REPLACED A NEW LENS. THE SURGERY TIME WAS PROLONGED FOR ABOUT 15-30 MINUTES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640779 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD MATERIAL DAMAGE IN THE OPTIC AREA. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THROUGH FOLLOW UPS, WE LEARNED THAT IOL SERIAL NUMBER (B)(6) OF THE SAME MODEL AND DIOPTER WAS IMPLANTED INSTEAD. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066576 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE DURING INTRAOCULAR LENS (IOL) IMPLANTATION. THE IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989477 ↗
• MalfunctionNov 4, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE AND REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO THE HAPTIC TORE OFF THE LENS IN THE CARTRIDGE. AN INCISION ENLARGEMENT WAS PERFORMED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. ANOTHER JOHNSON AND JOHNSON IOL OF DIFFERENT MODEL (AR40E) AND DIFFERENT DIOPTER (19.0 D) WAS IMPLANTED AS THE REPLACEMENT LENS. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 15740034 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. IT WAS ALSO REPORTED THAT IT WAS UNKNOWN IF THERE WAS PATIENT INJURY. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556996 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PCB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS OS VISION WORKED FINE FOR A WEEK AND THEN WENT FUZZY: OCULAR DEXTER (RIGHT EYE) HAS BEEN FUNCTIONING WELL. PATIENT HAS BEEN ABLE TO DRIVE UP UNTIL RECENTLY, LAST WEEK HE DECIDED TO SELL HIS CAR BECAUSE DRIVING WAS NOT SAFE. WHEN HE COMPLAINED TO HIS DOCTOR, HE WAS TOLD THE DOCTOR DID NOT KNOW WHAT WAS WRONG AND HE WAS SENT TO A RETINA SPECIALIST; HE HAS BEEN SEEING HIM FOR SEVERAL YEARS. PATIENT HAS HAD TWO (02) SECOND OPINIONS. THE RETINA SPECIALIST SENT HIM TO A DIFFERENT DOCTOR, SHE SAID SHE COULD NOT HELP HIM, SAYING IT WAS TOO COMPLICATED. SHE ALSO SAID THE EYE WAS NOT PERFORMING THE WAY SHE THOUGHT IT SHOULD. PATIENT IS NOW SEEING A NEW DOCTOR, WHO ALSO TOLD HIM HE DID NOT WANT TO OPERATE ON HIM. THE DOCTOR INDICATED THE PRICE WAS TOO HIGH TO JUSTIFY IT, BUT HE ALSO STATED HE HAD EYE PRESSURE ISSUES. HE SAID THE PRESSURE IS HIGH, AND IS BEING MONITORED FREQUENTLY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING PATIENT HAS STOPPED DRIVING DUE TO OS VISUAL ISSUES AND CONFIRMED NO ISSUES WITH OD VISION. OS EYE PRESSURE ISSUE HAS BEEN GOING

  Patient problems: Blurred Vision

  MAUDE report 15502700 ↗
• MalfunctionJul 26, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC CAME OFF PRIOR TO IMPLANTATION AND WITH NO CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP WE LEARNED THAT THE ISSUE OCCURRED AFTER REMOVAL FROM THE BOX, DURING THE IMPLANTATION PREPARATION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105541 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT (PT) EXPERIENCED ISSUES IMMEDIATELY. THE PT REPORTED SEEING FINE DURING THE DAY, BUT AT NIGHT SEES FLASHES OF LIGHTS WHEN DRIVING. THE PT DESCRIBED IT LIKE CARNIVAL FERRIS WHEEL LIGHTS IN THE PERIPHERAL VISION, MAKING THE PT DIZZY. THE PT ALSO EXPERIENCED DRY EYE AFTER SURGERY AND BEGAN USING OVER THE COUNTER LUBRICATING EYE DROPS. THE PT REPORTED THAT THREE MONTHS AFTER SURGERY, THE DOCTOR STATED THAT THE LENS WAS WRINKLED, AND WILL NEED TIME TO BECOME UNWRINKLED AND ADHERE TO THE EYE. AS OF MAY 23, 2022, THE DOCTOR STATED THAT THE LENS WAS IN CORRECTLY. THE DOCTOR RECOMMENDED LASIK AROUND THE EDGES, BUT STATED THAT IT PROBABLY WOULD NOT HELP. APPROXIMATELY FIVE MONTHS AFTER SURGERY, THE PT EXPERIENCED RED, ITCHY EYES THAT WERE ¿DRAINING.¿ THE PT DID A TELADOC VISIT AND WAS TOLD IT WAS INFLAMMATION AND WAS PRESCRIBED PREDNISOLONE ACETATE 1%. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PT IS UNABLE TO DRIVE AT NIGHT OR PERFORM DAILY ROUTINE ACTIVITIES DUE TO THIS ISSUE. THE PT HAS WAITED TWO YEARS FOR THE ISSUE TO RESOLVE AND IN THAT TIME HAS HAD TO C

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Dry Eye(s); Excessive Tear Production; Eye Injury; Inflammation; Red Eye(s); Visual Disturbances

  MAUDE report 14739562 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULUS SINISTER (LEFT EYE). OPTICAL ALTERATION WAS OBSERVED IN THE CENTRAL REGION OF THE IOL AFTER IMPLANTATION. THE ALTERATION SUGGESTS CONCENTRIC LIGHT UNDULATIONS. LEFT EYE WITH UNCORRECTED VISUAL ACUITY 20/25, CALM EYE, INCISIONAL EDEMA, AND ANTERIOR CHAMBER REACTION 1+/4. THERE WAS NO EXPLANT SO FAR, THE DOCTOR WILL EVALUATE THE PATIENT AGAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 13644820 ↗
• 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 13091090 ↗
• MalfunctionDec 3, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CUT OUT FROM THE PATIENT'S RIGHT EYE AS THE LENS WAS NOT MANUFACTURED CORRECTLY. THE HAPTIC OF THE LENS BROKE OFF WHILE PULLING IT OUT. THE PATIENT HAD SOME CORNEAL EDEMA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 12928004 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED DURING HANDLING AND PRIOR TO INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857391 ↗
• InjuryNov 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED AFTER THE PRE-LOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) IT WAS NOTICED THE TRAILING HAPTIC WAS MISSING. IT WAS NOTED THAT THERE WAS PATIENT INJURY. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION HOWEVER PATIENT INJURY WAS REPORTED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS DONG FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12853817 ↗
• MalfunctionNov 15, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) MISFIRED. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814783 ↗
• MalfunctionNov 2, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO PUT IN THE INTRAOCULAR LENS (IOL), THE LENS CAME OUT BEFORE CLICKING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741685 ↗
• 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 12686769 ↗
• MalfunctionOct 13, 2021Crack; Inaccurate Delivery; Mechanical Jam; Crack; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE, A SPLIT INJECTOR WAS OBSERVED WHEN SETTING-UP. FURTHER FOLLOW-UP REVEALED THAT THERE WAS NO REPORT OF ADDITIONAL SURGICAL MANEUVERS. CUSTOMER'S BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE INJECTOR WAS PARTIALLY INSERTED IN THE PATIENT'S EYE THEN WHEN THE DOCTOR WAS ADVANCING THE LENS THE INJECTOR CRACKED ON THE SIDE LEAVING THE LENS PARTIALLY DELIVERED. THE INJECTOR WAS IMMEDIATELY REMOVED FROM THE PATIENT EYE WITH THE LENS INSIDE OF IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE PCBOO LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS REPORTEDLY DOING VERY WELL. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627046 ↗
• MalfunctionOct 6, 2021Crack; Inaccurate Delivery; Mechanical Jam; Crack; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE, A SPLIT INJECTOR WAS OBSERVED WHEN SETTING-UP. FURTHER FOLLOW-UP REVEALED THAT THERE WAS NO REPORT OF ADDITIONAL SURGICAL MANEUVERS. CUSTOMER'S BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE INJECTOR WAS PARTIALLY INSERTED IN THE PATIENT'S EYE THEN WHEN THE DOCTOR WAS ADVANCING THE LENS THE INJECTOR CRACKED ON THE SIDE LEAVING THE LENS PARTIALLY DELIVERED. THE INJECTOR WAS IMMEDIATELY REMOVED FROM THE PATIENT EYE WITH THE LENS INSIDE OF IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE PCBOO LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS REPORTEDLY DOING VERY WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587161 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS DEFECTIVE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510928 ↗
• MalfunctionSep 5, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS FAULTY. THE ISSUE WAS FIRST IDENTIFIED UPON OPENING OF THE PACKAGING. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. IT WAS INDICATED THAT THE MATERIAL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426697 ↗
• 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 12338742 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Scratched Material; Break; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) GOT STUCK IN CARTRIDGE AND HAD PLUNGER ROD ISSUE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE SURGEON BELIEVED THE LENS WAS SCRATCHED BECAUSE OF THE PLUNGER AND REMOVED THE LENS IMMEDIATELY. THE PATIENT DID NOT SUFFER CONSEQUENCES. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171854 ↗
• InjuryMay 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM SURGEON AN INCIDENT INVOLVING AN INTRAOCULAR LENS, IMPLANTED IN A PATIENT'S EYE. AFTER LENS WAS UNFOLDED IT WAS EVIDENT THAT THE TRAILING HAPTIC HAD BEEN TORN OFF DURING INSERTION. WHEN CARTRIDGE WAS INSPECTED, PART OF THE HAPTIC COULD BE SEEN STILL INSIDE. THE SURGEON HAD TO CUT THE LENS AND REMOVE THE PIECE. THEN HAD TO REMOVE THE LENS FORM THE PATIENT'S EYE AND ENLARGE THE WOUND. SUTURES WERE APPLIED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11788083 ↗
• MalfunctionApr 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) HAD A TEAR ON IT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748769 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) OF A PRELOADED PRODUCT WAS DEFECTIVE. NO PATIENT INVOLVEMENT HAS BEEN REPORTED. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645074 ↗