TECNIS IOL PCB00 (REF PCB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 05050474558298), received between Dec 8, 2016 and Aug 28, 2025 — classified as 29 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 139 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED EXPERIENCING BLURRED VISION IN HER LEFT EYE, WHICH HAD A MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTED. THIS VISUAL IMPAIRMENT HAS AFFECTED HER ABILITY TO RECOGNIZE FACES ON HER TELEVISION. ADDITIONALLY, THE PATIENT OBSERVED A BLACK, FLOATING SPOT IN HER VISION. DESPITE USING OVER-THE-COUNTER EYE DROPS, THE BLURRED VISION PERSISTED. THE PATIENT INDICATED UNDERGOING BILATERAL IOL IMPLANTATION IN 2019. APPROXIMATELY FOUR MONTHS AGO, THE PATIENT NOTICED A BLACK DOT IN HER LEFT EYE, AND TWO MONTHS LATER, HER BLURRY VISION BEGAN. THE PATIENT MENTIONED THAT THIS ISSUE HAS BEEN RESOLVED, AND HER VISION IS CURRENTLY FINE WITH NO ISSUES. AROUND (B)(6) 2025, THE PATIENT RETURNED TO HER DOCTOR WHO REPORTEDLY CLEANED ALL THE GUNK IN HER LEFT EYE USING A LASER TREATMENT. THE PATIENT IS UNCLEAR WHETHER THE CONDITION WAS POSTERIOR CAPSULE OPACIFICATION (PCO) AND IF A YTTRIUM-ALUMINUM-GARNET (YAG) LASER WAS USED, ONLY RECALLING THAT A LASER WAS INVOLVED. THE PATIENT EMPHASIZED THAT ONLY HER LEFT EYE WAS TREATED, AND HER RIGHT EYE IS FINE. SHE CONFIRMED THAT NO ADDITIONAL MEDICATIONS OR PROCEDURES WERE PERFORMED ON HER EYE AT THAT TIME. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 22918730 ↗
• MalfunctionMay 23, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT WHEN THE LENS WAS IMPLANTED, THE LENS WAS NOT SMOOTHLY PUSHED INTO THE EYE. LATER, THE LENS WAS FOUND TO BE BROKEN AND HAD TO BE REMOVED FROM THE PATIENT EYE AND A NEW LENS WAS USED FOR IMPLANTATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388847 ↗
• MalfunctionJan 8, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466116 ↗
• MalfunctionJul 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING THE SURGERY DAY THE CUSTOMER HAD FIVE CASES OF FOREIGN MATERIAL ENTERING THE EYE DURING IMPLANTATION. PREVIOUS CASES HAD BEEN REPORTED BY THEM AND ON THIS SURGERY DAY, THE CUSTOMER USED HEALON PRO INSTEAD OF THEIR NORMAL (OPHTHALMIC VISCOSURGICAL DEVICE) OVD TO TRY AND EXCLUDE THE OVD AS THE SOURCE OF THE PARTICLE'S THEY ARE SEEING. BECAUSE THE ¿EXTRA MATERIAL¿ WAS STILL OBSERVED, IT WOULD APPEAR THAT THE PRE-LOADED LENS SYSTEM SEEMS TO BE THE SOURCE. NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER 4 INCIDENTS ON THE SURGERY DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414242 ↗
• InjuryJul 16, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THE PCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DOCTOR STATED THE IOL LOOKS SCRATCHED IN 2-3 PLACES AND THEY ARE MOSTLY LINEAR. PATIENT'S IS 20/20-2 BUT HE SAYS IT'S BLURRY. IT IS UNCLEAR IF THE PATIENT IS HAVING SYMPTOMS FROM THIS OR NOT. DOCTOR PERFORMED A YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE ON (B)(6)2023 TO SEE IF SHE COULD CLEAR UP ANY DEBRIS BEHIND THE LENS. IT MAY BE THAT THE PATIENT IS SEEING THE SCRATCH BECAUSE IT'S PRETTY CLOSE TO CENTER. THE DOCTOR THINKS IT IS RELATED HOW THE LENS MAY HAVE BEEN PRELOADED, THE SCRATCHES DON'T LOOK LIKE A THIN LINE, IT LOOKS LIKE A LINEAR WIDER TYPE SCRAPE. PATIENT IS CURRENTLY SEES A DOT (FLOATER) IN HIS FIELD OF VISION. PATIENT IS SCHEDULED FOR AN APPOINTMENT WILL BE ON (B)(6)2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 17330792 ↗
• MalfunctionJul 3, 2023Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROXIMAL HAPTIC JAMMED IN THE PLUNGER AND THEN CAME OUT PARTIALLY DAMAGED. THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253135 ↗
• MalfunctionApr 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EITHER MISSING A HAPTIC OR THE HAPTIC HAD BROKEN OFF AT SOME POINT IN THE LOADING SEQUENCE. THE SURGEON COULD NOT SEE THE MISSING HAPTIC IN THE EYE. THROUGH FOLLOW UP WE LEARNED THAT THE MISSING HAPTIC WAS OBSERVED DURING INSERTION OF THE IOL. ANOTHER LENS WAS PLACED UNDERNEATH THE DAMAGED LENS AND THE DAMAGED LENS WAS CUT TO ENABLE REMOVAL. ACCOUNT INDICATED THAT THE PROCEDURE HAD A 20 MINUTE DELAY. THE PATIENT IS REPORTEDLY DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738868 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BROKEN. THERE WAS NO PATIENT CONTACT AS THE EVENT WAS OBSERVED DURING HANDLING/PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524605 ↗
• MalfunctionFeb 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT HAPTIC DETACHMENT WAS OBSERVED ON THE PCB00 MODEL OF INTRAOCULAR LENS (IOL). UPON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449295 ↗
• MalfunctionFeb 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT HAPTIC DETACHMENT WAS OBSERVED ON THE PCB00 MODEL OF INTRAOCULAR LENS (IOL). UPON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449282 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) GOT STUCK WHEN THE STAMP PASSED OVER IT IN THE SHOOTER AND FINALLY TORE OFF. THERE WAS NO PATIENT CONTACT AND NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795774 ↗
• MalfunctionMar 25, 2022Contamination; Contamination

  IT WAS REPORTED THAT SURGEON FOUND A SMALL, THREAD-LIKE FOREIGN PARTICLE COMING FROM THE PCB00 INTRAOCULAR LENS (IOL). NO PATIENT ISSUES WERE CAUSED AND THE TWO SMALL, BLACK STRANDS WERE REMOVED USING RHEXIS FORCEP AND RETAINED. IT WAS INDICATED THAT THE LENS WAS INTACT WITH NO SCRATCH AND NO DAMAGE WHICH WAS POSITIONED EXACTLY INSIDE THE CHAMBER AS ANY LENSES ARE AND IMPLANTED WITHOUT ANY PROBLEMS. ANTIBIOTIC WAS GIVEN SAME AMOUNT AS THEY ALWAYS DO AND NO CHANGE IN IMMEDIATE POST-OP CARE. IT WAS CONFIRMED THAT THE FOREIGN MATERIAL WAS INTRODUCED INTO THE EYE AND THAT THE LENS REMAINS IMPLANTED WITHOUT ANY ISSUES. THE ACCOUNT IS CONVINCED THAT THE FOREIGN PARTICLE CAME OUT FROM THE INJECTOR WITH THE LENS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED, PATIENT OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13912653 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT THE LENS GOT BROKEN DURING THE IMPLANTATION. MATERIAL WAS DISCARDED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181072 ↗
• 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 13091101 ↗
• MalfunctionDec 22, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STUCK INTO THE PATIENT'S OPERATIVE EYE WHEN BEING IMPLANTED. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE FULLY INSERTED IOL WAS NOT ABLE TO UNFOLD INTO POSITION DUE TO BEING STUCK IN THE WOUND. THEREFORE, THE DOCTOR REMOVED AND REPLACED THE IOL WITH A BACK-UP LENS. PATIENT HAS REPORTEDLY FULLY RECOVERED. VISUAL ACUITIES PROVIDED AS 0.3 PRE-OPERATIVE AND 0.6 POST-OPERATIVE. THE REPLACED IOL WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065168 ↗
• MalfunctionDec 17, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE LENS WOULD NOT OPEN. IT WAS NOTED THAT THE DAILY ACTIVITIES OF THE PATIENT WAS NOT SIGNIFICANTLY AFFECTED AND THAT THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028865 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) MODEL PCB00 LENS WAS FOUND DEFECTIVE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783448 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON NOTICED SOME DAMAGE TO THE PRELOADED INTRAOCULAR LENS (IOL) ONCE IMPLANTED INTO PATIENT'S OPERATIVE EYE. THE SURGEON HAD TO CUT OUT THE LENS DURING THE SAME PROCEDURE AND REPLACED WITH A NEW LENS. NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643421 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) MODEL PCB00 WAS DAMAGED. ISSUE WAS OBSERVED UPON OPENING THE PACKAGING. PRODUCT WAS OPENED BUT NOT USED. IOL WAS DISCARDED AT THE SITE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355820 ↗
• 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 12338762 ↗
• 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 12338712 ↗
• MalfunctionJul 15, 2021Break; Mechanical Problem; Scratched Material; Break; Mechanical Problem; Scratched Material

  RECEIVED REPORT INDICATING THE PRELOADED INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE. THE PLUNGER WENT BEHIND THE LENS WHEN RELOADING. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE PROBLEM WAS DURING THE LOADING OF THE LENS. THE TECHNICIAN HAD TRIED TO ADVANCE THE LENS FURTHER INTO THE CARTRIDGE, THE PLUNGER WENT UNDERNEATH THE LENS IN THE CARTRIDGE INSTEAD OF RESTING BEHIND THE LENS. BEFORE INSERTING THE LENS INTO THE PATIENT, DOCTOR LOOKED AT THE LENS THROUGH THE MICROSCOPE AND SAID THE LENS WAS SCRATCHED AND REQUESTED ANOTHER LENS. THE LENS AND CARTRIDGE WERE BOTH NOT TOUCHED BY THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177858 ↗
• MalfunctionJul 9, 2021Inaccurate Delivery; Device Contaminated During Manufacture or Shipping; Inaccurate Delivery; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE DOCTOR AS HE INJECTED THE LENS A PIECE OF MATERIAL THAT LOOKED LIKE PLASTIC WEBBING DROPPED OFF THE LEADING HAPTIC INTO THE ANTERIOR CHAMBER. HE DID NOT INJECT THE LENS AND MANAGED TO RETRIEVE THE MATERIAL FORM THE EYE USING THE (IRRIGATION/ASPIRATION) I/A CANNULA. THERE WAS NO PATIENT INJURY AND NO WIDENING OF THE WOUND. MATERIAL IS AVAILABLE WITH THE TERRITORY MANAGER. THIS OCCURRED DURING IMPLANTATION. LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WERE NO INTERVENTIONS REPORTED. PROCEDURE WAS DELAYED FOR 10 MINUTES. IT WAS TICKED THAT THE CUSTOMER HAS NO FURTHER INFORMATION THAN WHAT HAS BEEN PROVIDED IN THE INTAKE FORM. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE LENS WAS PARTIALLY INSERTED. A SECOND LENS WAS USED SUCCESSFULLY AND THE PATIENT DISCHARGED WITHOUT ANY EFFECTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146716 ↗
• MalfunctionJun 17, 2021Break; Break

  CUSTOMER REPORTED A DEFECTIVE LENS, NOT USED. CUSTOMER DOESN'T KNOW IF THERE WAS PATIENT CONTACT OR NOT. BACKUP LENS WAS USED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021328 ↗
• MalfunctionMay 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE PATIENT'S RIGHT EYE, THE HAPTIC WAS TORN OFF. THE LENS WAS CUT OUT AND REPLACED WITH A SAME DIOPTER IOL. IT WAS NOTED THAT THERE WAS NO INCISION ENLARGEMENT. THE PATIENT HAS RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891248 ↗