TECNIS IOL PCB00 (REF PCB0000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 05050474558281), received between Aug 29, 2016 and Apr 8, 2024 — classified as 37 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INJECTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), ONCE IN THE PATIENT'S EYE, THE LENS APPEARED WITHOUT THE PROXIMAL LOOP. THE PROXIMAL LOOP WAS INSIDE THE CARTRIDGE AFTER LENS INJECTION. THE IOL WAS EXPLANTED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068194 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS (IOL) WAS FOUND DAMAGED DURING THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466339 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD), THE PATIENT INITIALLY REPORTED HAVING NO ISSUES. HOWEVER, THE PATIENT NOTED THAT THE VISION IN THE OD IS GETTING WORSE OVER TIME. MEDICAL RECORDS WERE RECEIVED, WHICH PROVIDED ADDITIONAL INFORMATION. BASED ON PRE-OPERATIVE CALCULATIONS, THE REFRACTIVE TARGET FOR THE OD WAS PLANO. THE CATARACT SURGERY OPERATIVE REPORT OD DESCRIPTION INCLUDED THE SURGEON'S STANDARD PRE-OPERATIVE, INTRA-OPERATIVE, AND POST-OP CATARACT SURGERY STEPS WHICH WERE FOLLOWED WITH NO COMPLICATIONS. NO SECONDARY SURGICAL OR MEDICAL INTERVENTIONS WERE PERFORMED OUTSIDE OF STANDARD OF CARE. ON (B)(6), 2022, THE PATIENT VISUAL ACUITY (VA) OD WAS 20/20 AND INTRAOCULAR PRESSURE (IOP) WAS 16. ON (B)(6), 2022, THE ORIGINAL SURGEON PRESCRIBED INRELTYS FOUR TIMES A DAY (QID) AND THE PATIENT¿S UNCORRECTED (SC) VA OD WAS 20/20-1 AND IOP WAS 13. ON (B)(6), 2022, THE PATIENT¿S VA SC OD WAS 20/20-1 AND IOP WAS 15. THE PATIENT WAS ALSO DIAGNOSED WITH DRY EYE SYNDROME AND PRESCRIBED ARTIFICIAL TEARS, ONE DROP QID AND AS NEEDED. ON (B)(6), 2022, THE PATIENT¿S OD VA WAS 20/20-2. ON (B)(6), 2022, THE PATIENT WAS EXAMINED BY A DIF

  Patient problems: Blurred Vision; Dry Eye(s); Unspecified Eye / Vision Problem; Uveitis; Visual Impairment

  MAUDE report 18062613 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT THE OPTIC OF AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS A FRAGMENT OF THE OPTIC MISSING. THE LENS WAS FULLY INSERTED AND WAS REMOVED DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND THERE WAS A DELAY IN THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

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

  MAUDE report 16275158 ↗
• MalfunctionNov 22, 2022Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT DEPLOY. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE INJECTOR TIP SEEMED THIN AND SPLIT. ONLY THE CARTRIDGE TIP MADE CONTACT WITH PATIENT'S OPERATIVE EYE, HOWEVER, THERE WAS NO INJURY TO THE PATIENT. NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849895 ↗
• MalfunctionOct 18, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE LENS WAS DEFECTIVE BECAUSE THERE WAS INJECTOR OUTPUT FAILURE (BENT LENS). THROUGH FOLLOW-UP IT WAS LATER INDICATED THAT IT WAS UNKNOWN IF THE LENS WAS ALREADY BENT OR IF THE LENS WAS BENT DUE TO THE INJECTOR'S FAILURE. THAT THE LENS DID NOT COME OUT. THE CARTRIDGE WAS NOT DAMAGED. THE TIP OF THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S EYE BUT THERE WAS NO PATIENT INJURY. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623123 ↗
• MalfunctionJun 7, 2022Break; Crack; Failure to Fold; Break; Crack; Failure to Fold

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOLDED INCORRECTLY AND THE OPTIC WAS BROKEN AS A RESULT. MATERIAL IS NOT AVAILABLE. ISSUE WAS DISCOVERED DURING IMPLANTATION AND THE LENS WAS FULLY INSERTED. THERE WAS NO DELAY IN PROCEDURE OR MEDICATION PRESCRIBED, AND NO FURTHER INTERVENTION WAS REPORTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. IT WAS INDICATED THAT THE CUSTOMER HAS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14625883 ↗
• MalfunctionJun 7, 2022Break; Crack; Failure to Fold; Break; Crack; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS FOLDED ACROSS TOO WIDE AND THE SHOOTER BROKE OPEN. THE IOL WAS IMPLANTED BUT THE OPTIC WAS BROKEN. THE IOL WAS THEN REMOVED AND A NEW LENS WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS OKAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14624824 ↗
• InjuryApr 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE LEFT EYE BECAUSE THE CAPSULAR BAG WAS DAMAGED WHEN IT WAS PLACED, SINCE THE LENS WAS TORN. A PHACOVITRECTOMY WAS PERFORMED. A THREE-PIECE IOL WAS IMPLANTED AS THE REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14189894 ↗
• MalfunctionMar 9, 2022Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery

  THE LENS WAS INITIALLY RECEIVED WITHOUT ANY ISSUE DESCRIPTION OR OTHER DETAILS. DUE DILIGENCE FOLLOW-UP PERFORMED BUT TO NO AVAIL. MEANWHILE, PRODUCT INVESTIGATION WAS COMPLETED AND VERIFIED THAT A HAPTIC GOT STUCK IN THE HANDPIECE DURING DELIVERY WHILE THE LENS WAS DEPLOYED. THE LENS WAS CUT SIMILAR TO WHEN THE LENS IS REMOVED OR EXPLANTED FROM THE EYE. THEREFORE, THE FILE WAS PROCESSED ACCORDINGLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716298 ↗
• InjuryFeb 1, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE LEAD HAPTIC OF THE INTRAOCULAR LENS (IOL) CAME OUT OF THE APPLICATOR SO THAT IT INJURED THE CAPSULE. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE AND WAS EXCHANGED FOR A SULCUS LENS. THE PATIENT IS FINE AND THERE WERE NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13418961 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A CATARACT OPERATION, THE DOCTOR NOTICED THAT THE HAPTICS WERE LOOKING ¿FUNNY¿ AFTER DEPLOYING THE LENS INTO THE EYE. THE LENS WAS FULLY INSERTED AND THEN REMOVED DURING THE SAME SURGERY. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE INCISION WAS ENLARGED AND THERE WAS NO VITRECTOMY REQUIRED. NO OTHER PATIENT INTERVENTIONS WERE MENTIONED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808011 ↗
• 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 12686763 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510870 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS A DAMAGED LENS WAS OBSERVED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478131 ↗
• MalfunctionSep 13, 2021Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD A DAMAGED LENS AS IT WAS BROKEN WHEN DEPLOYED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464880 ↗
• 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 3 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222351 ↗
• MalfunctionJul 15, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE TECHNICIAN HEARD AN UNUSUAL NOISE WHEN HANDLING THE PRELOADED INTRAOCULAR LENS (IOL) AND CONSIDERED IT TO BE DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THROUGH FOLLOW UP IT WAS LEARNT THAT AS THE TECHNICIAN PROCEEDED TO PUSH THE LENS LOADER FORWARD TO THE SECOND MARK ON THE LOADER AS WAS STANDARD PROTOCOL, A CRUNCH NOISE WAS HEARD RATHER THAN HEARING THE TYPICAL SLIGHT CLICK SOUND. THE CRUNCHING SOUND WAS BELIEVED TO HAVE COME FROM WHERE THE LENS WAS LOCATED AND THAT THE LENS HAD BEEN CRUNCHED OR BECAME UNUSABLE. THE TECHNICIAN INDICATED THAT THE LENS MUST HAVE BEEN PLACED IN THE LENS INSERTOR IMPROPERLY, WHICH WAS VERIFIED BY THE DOCTOR UPON EXAMINING UNDER THE MICROSCOPE. THEREFORE, THE LENS WAS DETERMINED NOT SAFE TO USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177916 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CHIPPED COMING OUT OF THE CARTRIDGE. THROUGH FOLLOW UP WE LEARNED THAT THE ISSUE OCCURED PRIOR TO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979969 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FORM THE PATIENT'S RIGHT EYE DUE TO UNEXPECTED POST-OP REFRACTION. IT WAS STATED THAT THE PATIENT COULD NOT SEE DISTANCE. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL PRELOADED LENS, DCB00. THERE WAS NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS REPORTED TO BE DOING WELL SO FAR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11918393 ↗
• MalfunctionMar 27, 2021Break; Material Fragmentation; Difficult to Advance; Break; Material Fragmentation; Difficult to Advance

  IT WAS REPORTED THAT HAPTIC LEG WAS STUCK IN INJECTOR, DETACHED FROM LENS. LENS WAS IMPLANTED AND AFTER THAT REMOVED AND REPLACED FROM PATIENT'S EYE. THIS HAPPENED TWICE TO SAME PATIENT WITH TWO DIFFERENT LENSES DURING SAME PROCEDURE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT CAPTURES THE SECOND OF THE TWO LENSES A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579578 ↗
• InjuryMar 27, 2021Material Fragmentation; Difficult to Advance; Material Fragmentation; Difficult to Advance

  IT WAS REPORTED THAT HAPTIC LEG WAS STUCK IN INJECTOR, DETACHED FROM LENS. LENS WAS IMPLANTED AND AFTER THAT REMOVED AND REPLACED FROM PATIENT'S EYE. THIS HAPPENED TWICE TO SAME PATIENT WITH TWO DIFFERENT LENSES DURING SAME PROCEDURE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT CAPTURES ONE OF THE TWO LENSES A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579564 ↗
• MalfunctionMar 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT HAVE A HAPTIC. THE LENS WAS INSERTED INTO PATIENT'S LEFT EYE AND REMAINS IMPLANTED. THE PATIENT SEES VERY WELL AND THERE ARE NO OTHER ISSUES. THE PATIENT HAS FULLY RECOVERED AND DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. THE POST OP VISUAL ACUITY WAS 6/6. THERE WERE NO OTHER MEDICAL INTERVENTION THAT WAS REQUIRED. THE EVENT WAS OBSERVED DURING IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401902 ↗
• MalfunctionMar 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS NOT STERILE. IT WAS STATED THAT THERE WAS NO PATIENT CONTACT. AFTER SEVERAL FOLLOW-UPS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396912 ↗
• MalfunctionFeb 19, 2021Break; Failure to Fold; Material Fragmentation; Failure to Advance; Break; Failure to Fold; Material Fragmentation; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD LOADING ISSUE AND HAPTIC WAS COMING OUT FIRST. THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED DURING HANDLING, BUT PRIOR TO INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355875 ↗