TECNIS IOL PCB00 (REF PCB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 05050474558304), received between Sep 8, 2016 and Nov 15, 2024 — classified as 47 injuries, 82 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG WAS INJURED AND SLIGHTLY TORN DURING IMPLANTATION AS THE SIDE PART OF THE OPTIC OF A PRELOADED MONOFOCAL INTRAOCULAR LENS WAS RELEASED INSTEAD OF THE HAPTIC PART. LENS WAS FULLY INSERTED AND REMAINED IMPLANTED IN THE EYE. SURGEON DETERMINED NOT TO EXPLANT THE LENS AS IT WOULD MAKE THE SITUATION WORSE. THERE IS NO REPORT OF UNPLANNED VITRECTOMY, INCISION ENLARGEMENT AND SUTURES. THERE IS NO DELAY IN PROCEDURE. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20695577 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THERE WAS LENS DAMAGED DURING THE IMPLANTATION OF PRELOADED ASPHERIC SINGLE-PIECE ACRYLIC INTRAOCULAR LENS AND THE USE WAS IMMEDIATELY STOPPED AND A NEW INTRAOCULAR LENS WAS REPLACED. THE INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED WITHOUT DAMAGE TO THE PATIENT. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684717 ↗
• InjuryApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) BROKE AFTER THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE IOL WAS REMOVED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184868 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOCTOR NOTICED THE ABSENCE OF THE PRELOADED INTRAOCULAR LENS (IOL) HAPTIC THROUGH THE CARTRIDGE/INJECTOR BEFORE USE AND EJECTED IT ON THE STERILE TABLE WITHOUT TOUCHING THE PATIENT. THE HAPTIC WAS ALREADY DETACHED FROM THE LENS BEFORE LOADING. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068153 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED DURING THE IMPLANTATION OF IOL INTO THE PATIENT'S EYE, IT WAS FOUND THAT THE INTRAOCULAR LENS HAPTIC WAS BROKEN AND THE LENS WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023987 ↗
• MalfunctionOct 6, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS (IOL) WITH MODEL PCB00 WAS DAMAGED DURING LENS PREPARATION PROCESS. WHEN A SURGEON ADVANCED THE PLUNGER, IT WAS NOT PUSHED BY THE PLUNGER ENOUGH AND IOL GOT STUCK INSIDE THE CARTRIDGE. THEY USED OTHER MANUFACTURER LENS TO COMPLETE THE SURGERY SINCE THE IOL HAPTIC WAS PARTIALLY DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889986 ↗
• InjuryMay 1, 2023Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED DURING IMPLANTATION OF THE PCB00 INTRAOCULAR LENS (IOL) THERE WAS A SCRATCH/TEAR ON LENS OPTICAL BELT. THERE WAS NO PRESCRIBED MEDICATION, NO PROCEDURAL DELAY, NO SUTURE(S), AND NO VITRECTOMY, THE INCISION WAS ENLARGED AND MEDICAL ATTENTION WAS REQUIRED, DETAILS REGARDING MEDICAL ATTENTION ARE UNKNOWN. PATIENT'S DAILY ACTIVITIES ARE NOT AFFECTED. PATIENT IS TEMPORARILY IMPAIRED AS IMAGES ARE DISTORTED. THE PCB00 IOL MAY BE EXPLANTED. IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 16850397 ↗
• MalfunctionJan 19, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD FIBERS ON IT WHEN IMPLANTED IN THE PATIENT'S LEFT EYE. 3 LITTLE STRIPS OF FIBER. DOCTOR WAS ABLE TO REMOVE THEM AND LEFT THE LENS IMPLANTED. DOCTOR VERY CONCERNED. DOCTOR HAD TO FLIP IOL SIDEWAYS AND FIBERS SEEMED TO BE ON THE BACK SIDE OF THE LENS. NO PLANNED ADDITIONAL INTERVENTION. PATIENT DOING FINE POST-OP. FURTHER FOLLOW-UP CONFIRMED THAT THERE WERE THREE VERY THIN FIBERS STUCK TO THE POSTERIOR ASPECT OF THE IOL. ALL 3 SEEMED TO BE STUCK TOGETHER AT THE BASE OF THE ATTACHMENT TO THE LENS BUT FRAYING APART FROM EACH OTHER. THE DOCTOR NOTICED IT AFTER HE IMPLANTED THE IOL INTO THE LENS CAPSULE. DOCTOR WAS ABLE TO LIFT UP THE IOL WITH I&A HAND PIECE AND GO BEHIND THE LENS AND ASPIRATE IT WITHOUT TEARING THE CAPSULE. DOCTOR CAN¿T REALLY SAY IF IT HAD ANY COLOR AS IT BLENDED IN REALLY WELL BUT IT DEFINITELY WAS NOT BLACK OR ANY OTHER OBVIOUS COLOR LIKE RED OR GREEN. THE FIBERS ARE NOT RETURNING TO US AS WELL AS THEY WERE ASPIRATED BY THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16208013 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SPLIT. THROUGH FOLLOW UP WE LEARNED THAT THE SPLIT WAS IDENTIFIED WHEN THE LENS CAME OUT OF THE TIP OF THE INJECTOR DURING IMPLANTATION. THERE WAS PATIENT CONTACT BUT NO ISSUES WERE REPORTED SINCE A NEW LENS WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966280 ↗
• InjuryOct 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT EYE, HAPTIC WAS STUCK TO HAPTIC. DOCTOR TRIED TO UNHOOK THE HAPTICS AFTER THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) REMOVAL AND CAUSED POSTERIOR CAPSULE RAPTURE (RENT). VITRECTOMY WAS PERFORMED. IOL WAS REMOVED FROM THE PATIENT EYE WITH INCISION ENLARGED AND SUTURES REQUIRED. THERE WAS A DELAY IN PROCEDURE AND MEDICATION WAS PRESCRIBED. PRODUCT NOT AVAILABLE FOR RETURN. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 15547972 ↗
• MalfunctionSep 1, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED AND FAILED TO INJECT. THE LENS WAS NOT IMPLANTED INTO PATIENT'S OPERATIVE EYE. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342131 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED POST OPERATIVE ENDOPHTHALMITIS POST INTRAOCULAR LENS (IOL) IMPLANTATION. THE SURGEON MENTIONED NOTICING A LOT OF PUS SURROUNDING THE LENS AREA IN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 14505246 ↗
• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER FOUND A SMALL V SHAPED DEFECT AT THE PERIPHERY OF THE LENS DURING IMPLANTATION. IT LOOKED LIKE A MANUFACTURING FAULT AND THE LENS WAS LEFT IMPLANTED AS THE FAULT WAS ON THE EDGE OF THE OPTIC. THE SURGEON WAS CONCERNED ABOUT THE POSSIBILITY OF A SHARP EDGE SO PLACED IT INTO POSITION CAREFULLY AND ALL WAS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14175755 ↗
• MalfunctionApr 6, 2022Break; Break

  THE ACCOUNT REPORTED DETERIORATED/DEFECTIVE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018693 ↗
• 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 THIRD REPORTED EVENT. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262430 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, POST INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, PATIENT EXPERIENCED BLURRY VISION AND WATERY EYE. PATIENT INDICATED THAT THEY WERE USING EYE DROPS AND WERE ALSO GETTING HEADACHES. PATIENT PROVIDED NOT BEING CERTAIN THAT THE HEADACHES AND HER VISION ISSUE WERE ASSOCIATED. PATIENT WAS ADVISED TO CONSULT HER DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Headache; Insufficient Information

  MAUDE report 13172996 ↗
• MalfunctionDec 19, 2021Break; Break

  IT HAS BEEN REPORTED THAT THE LENSES WERE DEFECTIVE. NO INFORMATION REGARDING PATIENT INVOLVEMENT OR PATIENT INJURY HAVE BEEN PROVIDED, NOR ABOUT MATERIAL AVAILABILITY. NO MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR THE SECOND LENS. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER REPORTED LENSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040271 ↗
• 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 12339697 ↗
• MalfunctionAug 13, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE LEAD HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT UNFOLD CORRECTLY WHEN INSERTED INTO PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER (22.0 D) DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321612 ↗
• 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 2 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222350 ↗
• 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 RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: Red Eye(s)

  MAUDE report 12222343 ↗
• MalfunctionJul 16, 2021Break; Break

  IT HAS BEEN REPORTED THAT AN INTRAOCULAR LENS (IOL) IS DEFECTIVE, NO MORE DETAILS. UNKNOWN IF PATIENT CONTACT. NO PATIENT INJURY HAS BEEN REPORTED SO FAR. NO FURTHER INFORMATION HAS BEEN PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185920 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE PATIENT MOVED THEIR HEAD WHILE INJECTING THE LENS INTO THE EYE. THE IOL GOT CAUGHT IN THE INCISION. THROUGH FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE IOL WAS PARTIALLY INSERTED. THERE WERE NO INJURIES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP IOL. REPORTEDLY, THE LENS WAS DAMAGED DURING THE REMOVAL PROCESS AND NO DAMAGE WAS NOTICED PRIOR TO THE INSERTION. THERE WAS NO USE ERROR REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178139 ↗
• MalfunctionJul 7, 2021Crack; Crack

  IT WAS REPORTED THAT AFTER CORRECTLY PREPARING THE LENS AND IMPLANTATION THE CARTRIDGE TIP WAS FOUND TO BE FRAYED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129537 ↗
• MalfunctionApr 23, 2021Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED BY THE SURGEON THAT HE HAD NO PROBLEMS WHEN MOUNTING THE INTRAOCULAR LENS (IOL), BUT AT THE END OF THE SURGERY, WHEN THE IOL OPENED INSIDE THE PATIENT¿S EYE, HE NOTICED THE IOL HAD GROOVES IN THE BORDER/EDGE. IT WAS LEARNED THAT DURING THE SURGERY, THE SURGEON HAD TO ROTATE THE LENS WITH THE PURPOSE OF HIDING THE GROOVES, HOPING THAT THE OPACIFICATION OF THE ANTERIOR CAPSULE, AFTER 3 MONTHS OF SURGERY, WOULD BLOCK THE LIGHT THAT WOULD PASS THROUGH THAT REGION GENERATING DYSPHOTOPSIAS. THE ADEQUATE INTERVENTION WOULD BE THE IOL EXCHANGE, HOWEVER THE RISKS OF AN EXPLANT IS HIGHER THAN THE POSSIBLE SYMPTOMS THE PATIENT MAY PRESENT. IT WAS NOTED THAT THE PCB00 IOL IS ALWAYS VERY MUCH STUCK TO THE INJECTOR AND THE FIRST MOVEMENT TO TAKE THE LENS OFF SEEMS TO REQUIRE TO MUCH FORCE. THE DOCTOR BELIEVES THE LENS WAS MARKED AT THAT MOMENT. NO PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713274 ↗