TECNIS IOL PCB00 (REF PCB0000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474558380), received between Aug 23, 2016 and Aug 5, 2022 — classified as 11 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT A FRAGMENT IN THE INJECTOR WAS INJECTED INTO THE EYE. IT WAS 2 X 1.5MM AND WHITE. THE FRAGMENT WAS REMOVED FROM EYE AND ONCE DRIED IT WAS BLUE. THE LENS WAS FULLY INSERTED AND REMAINS IMPLANTED. THE PATIENT IS FULLY RECOVERED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PARTICLE AND PRELOADED INSERTER WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173100 ↗
• MalfunctionJan 13, 2022Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN IOL (INTRAOCULAR LENS), THE DOCTOR SAW THAT A TEAR IN THE CARTRIDGE AND ONE OF THE HAPTICS WANTED TO GET THROUGH. HE STOPPED AND REMOVED THE INSERTER TOGETHER WITH THE IOL FROM THE EYE. A NEW LENS AND INSERTER WERE USED INSTEAD. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE DAMAGE WAS AT THE CARTRIDGE TIP SECTION. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED AND NO FURTHER DETAILS PROVIDED. THIS EMDR REPORT IS FOR THE FIRST REPORTED EVENT. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13247661 ↗
• MalfunctionSep 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PUT INTO THE PATIENT'S EYE BUT ONE OF THE HAPTICS HAD BROKEN OFF. THIS WAS NOT NOTICED UNTIL THE LENS HAD UNFOLDED. THE LENS WAS REMOVED IN VARIOUS PIECES FROM THE PATIENT'S EYE AND DISPOSED OF. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411776 ↗
• MalfunctionMay 27, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THERE WAS A PROBLEM WITH THE INJECTOR OF A PRELOADED PRODUCT. THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE, BUT IT DID NOT TOUCH THE PATIENT'S EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891809 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOLS) WAS FAULTY DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. AFTER SEVERAL FOLLOW-UP NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633221 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED NOT USED. APPARENTLY, THERE WAS CAPSULAR RUPTURE. THE CUSTOMER THEN HAD TO DO VITRECTOMY. THE PROCEDURE WAS COMPLETED USING THE BACK-UP IOL OF THE SAME MODEL AND DIOPTER WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10368804 ↗
• MalfunctionApr 2, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT WHILE THE DOCTOR TRIED TO SCREW THE INTRAOCULAR LENS (PCB00) INTO THE EYE THE SYSTEM STOPPED SCREWING. THE LENS PARTLY CAME OUT INTO THE EYE BUT HALF WAY THE SYSTEM DID NOT SCREW ANYMORE FORWARD. SURGERY WAS ENDED SUCCESSFULLY AS NURSE/DOCTOR USED ANOTHER PCB00. NO PATIENT INJURY IS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914710 ↗
• MalfunctionDec 12, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A CATARACT SURGERY, AN INTRAOCULAR LENS, MODEL PCB00 GOT STUCK IN THE CARTRIDGE DURING IMPLANTATION. HAPTIC WAS IN CONTACT WITH THE PATIENT EYE DUE THE FACT THAT THE LENS WAS PARTLY OUT OF THE CARTRIDGE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9456069 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL), 26.0 DIOPTER POWER WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO DECREASED VISUAL ACUITY. THE REPLACEMENT LENS WAS ANOTHER PCB00 IOL, BUT LOWER DIOPTER (22.5). IT WAS NOTED THAT THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9387036 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 TO IMPROVE PATIENT'S VISION. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER 23.0 DIOPTER LENS. THERE WAS NO SURGICAL INTERVENTION REPORTED AND PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9331582 ↗
• MalfunctionJul 15, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANT OF THE INTRAOCULAR LENS (IOL), A FIBER WAS NOTED. THE FIBER WAS REMOVED AND THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787846 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION AND REDUCED VISUAL ACUITY. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT, NO SUTURES REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8291579 ↗
• InjuryJan 30, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF A PCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS BENT WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THERE WAS AN INCISION ENLARGEMENT AND SUTURE USED, BUT NO VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8287960 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS PRELOADED MONOFOCAL INTRAOCULAR LENS (MODEL PCB00, +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING NEGATIVE DYSPHOTOPSIA THAT WOULD NOT GO. THERE WAS SLIGHT INCISION ENLARGEMENT PERFORMED DUE TO NEW LENS REQUIRING 2.8 MM INCISION. THERE WAS NO VITRECTOMY, ONE 10.0 SUTURE WAS USED TO SEAL THE WOUND. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT LENS. THERE WAS NO PATIENT INJURY. PATIENT WAS DOING WELL POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8011782 ↗
• MalfunctionOct 1, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THE HAPTIC WAS TORN OFF. PATIENT CONTACT WITH THE IOL WAS REPORTED. NO INCISION ENLARGEMENT, NO SUTURES USED AND NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS DISCARDED BY THE ACCOUNT. ANOTHER LENS, SAME MODEL AND DIOPTER, WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921663 ↗
• MalfunctionApr 3, 2018Difficult to Fold, Unfold or Collapse; Sticking; Difficult to Fold, Unfold or Collapse; Sticking

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE END OF THE TRAILING HAPTIC WAS OBSERVED TO BE STUCK UNDER THE OPTIC. REPORTEDLY, THE IOL DID NOT UNFOLD CORRECTLY AND TWISTED A LOT. THERE WERE NO COMPLICATIONS REPORTED AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT MANIPULATION WAS REQUIRED IN ORDER TO RELEASE THE HAPTIC. THERE WAS A MINIMAL DELAY AND NO FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THE SAME EVENT ON FOUR (4) OCCASIONS. THIS REPORTS REPRESENTS REPORT THREE OF FOUR REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7394911 ↗
• MalfunctionFeb 21, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL PCB00) DID NOT COME OUT OF THE CARTRIDGE AFTER THE SECOND PUSH. REPORTEDLY, ANOTHER PCB00 LENS WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CLARIFIED THAT THE LENS TOUCHED THE PATIENT''S EYE. NO INCISION ENLARGEMENT AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287675 ↗
• MalfunctionFeb 16, 2018Scratched Material; Scratched Material

  THE CUSTOMER REPORTED A SCRATCHED INTRAOCULAR LENS (IOL) WITH PATIENT CONTACT. THE IOL WAS PARTIALLY DELIVERED INTO THE RIGHT EYE AND REMOVED DUE TO THE SCRATCH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP IOL. THERE WAS NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY PERFORMED. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7278994 ↗
• InjuryJan 5, 2018Difficult to Insert; Unintended Movement; Difficult to Insert; Unintended Movement

  IT WAS REPORTED THAT A PCB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) DEPLOYED ITSELF UPSIDE DOWN AND ROTATED. THERE WAS ALSO A CAPSULAR TEAR THAT OCCURRED AND A VITRECTOMY WAS PERFORMED. THE LENS WAS THEN REMOVED AND THE PATIENT WAS LEFT APHAKIC. THEREAFTER, THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL. REPORTEDLY, THE TECHNICIAN STATED SHE MAY HAVE INSERTED THE LENS ON THE WRONG SIDE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7170413 ↗
• MalfunctionDec 4, 2017Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP WAS CRACKED FOR 2 PCB00 TECNIS ITEC PRELOADED 1-PIECE INTRAOCULAR LENSES. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH IMPACTED PRODUCT. THIS REPORT REPRESENTS 2 OF 2 MDRS.

  Patient problems: No Patient Involvement

  MAUDE report 7081020 ↗
• MalfunctionDec 4, 2017Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP WAS CRACKED FOR 2 PCB00 TECNIS ITEC PRELOADED 1-PIECE INTRAOCULAR LENSES. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH IMPACTED PRODUCT. THIS REPORT REPRESENTS 1 OF 2 MDRS.

  Patient problems: No Patient Involvement

  MAUDE report 7080983 ↗
• MalfunctionSep 27, 2017Break; Break

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF A PRELOADED DELIVERY SYSTEM (MODEL (B)(4) WAS CHIPPED. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6899760 ↗
• MalfunctionSep 25, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON INSERTION OF THE INTRAOCULAR LENS (IOL) UNDER THE SURGICAL MICROSCOPE, THE DOCTOR NOTICED SOME IRREGULARITIES ON THE POSTERIOR EDGE OF THE IOL, CLOSE TO BUT NOT ON THE HAPTIC-OPTIC JUNCTION. THE DOCTOR TRIED TO ASPIRATE/RUB THESE ¿¿FIBER-LIKE¿¿ ASPERITIES WITHOUT SUCCESS. THE SURGERY WAS NORMALLY PERFORMED. PROVISC WAS USED AS VISCOELASTIC. THERE WAS NO PATIENT INJURY REPORTED. PATIENT OUTCOME WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6889447 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 26.0 DIOPTER WAS INSERTED AND REMOVED DUE TO A CAPSULE TEAR/COLLAPSE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6568214 ↗
• InjuryApr 25, 2017Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PLASTIC PIECE/DEPOSIT WAS FOUND IN THE ANTERIOR CHAMBER (AC) POST IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT EYE. NEITHER THE SURGEON NOR THE NURSE CAN IDENTIFY THE ORIGIN OF THE PLASTIC MATTER. THE SURGEON USED FORCEPS TO REMOVE THE PARTICLE FROM THE PATIENT¿S EYE. THERE WAS A SMALL HEMORRHAGE AT WOUND SITE. THE IOL REMAINS IMPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY. IT WAS STATED THAT THE PATIENT OUTCOME IS NORMAL, AND THAT THE SMALL HEMORRHAGE WAS CONTROLLED WITH SLIGHT PRESSURE. THERE WAS NO NEED FOR ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. IN ADDITION, A PLUNGER ROD ISSUE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6517681 ↗