TECNIS IOL PCB00 (REF PCB0000265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474558397), received between Nov 2, 2016 and Oct 6, 2022 — classified as 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE SHOOTER WAS BROKEN, AND THAT THE EDGE OF THE INTRAOCULAR LENS (IOL) WAS DAMAGED BY THE PLUNGER. THROUGH FOLLOW UP WE LEARNED THAT THE SURGEON TRIED TO IMPLANT THE LENS WITH TWEEZERS, BUT THIS DID NOT WORK. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552545 ↗
• MalfunctionJan 12, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13240436 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED PRODUCT INTRAOCULAR LENS (IOL) WAS BROKEN IN THE INJECTOR DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980015 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED. ACCOUNT INDICATED THAT THE IOL WAS NOT IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921918 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IMPLANT CARD WAS RECEIVED INDICATING THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12375727 ↗
• InjuryAug 16, 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 FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE MISS, THE PATIENT WAS UNHAPPY WITH VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. PATIENT OUTCOME WAS NOTED AS NO COMPLICATIONS. ANOTHER JOHNSON & JOHNSON LENS (MODEL DCB00 AND LOWER DIOPTER 23.5) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Impairment

  MAUDE report 12329238 ↗
• MalfunctionMay 14, 2021Break; Mechanical Problem; Difficult to Advance; Break; Mechanical Problem; Difficult to Advance

  IT HAS BEEN REPORTED ISSUES WITH A PCB00. DEFECTIVE LENS BECAUSE EMBOLUS WENT OVER THE LENS. THE LENS WAS PARTIALLY INSERTED AND THE ISSUE WAS AT FIRST NOTICED DURING IMPLANTATION/APPLICATION. NO PATIENT INJURY HAS BEEN REPORTED, PATIENT IS FULLY RECOVERED. LENS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE MATERIAL IS AVAILABLE FOR INVESTIGATION IF REQUIRED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION HAS BEEN PROVIDED. NOTE: EMBOLO IN SPANISH IS PLUNGER IN ENGLISH. SO BY EMBOLO OVER LENS MEANS OVERRIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828571 ↗
• MalfunctionFeb 26, 2021Break; Crack; Break; Crack

  IT HAS BEEN REPORTED ISSUES WITH A PCB00. SHOOTER BROKEN, NO FURTHER INFORMATION PROVIDED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11385267 ↗
• MalfunctionApr 15, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PCB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS THREE QUARTERS OF THE WAY INTO THE EYE AND WOULD NOT ADVANCE FURTHER. THE LENS WAS PARTIALLY DELIVERED INTO THE PATIENT¿S OPERATIVE AS THE IOL WOULD NOT ADVANCE FURTHER(STUCK IN CARTRIDGE). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961079 ↗
• InjuryApr 13, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A TECNIS PCB00 INTRAOCULAR LENS (IOL) THE LENS WAS TORN AND MISSING THE TRAILING HAPTIC WHEN RELEASED FROM THE CARTRIDGE. THE LENS HAD TO BE CUT-UP AND REMOVED FROM THE EYE WHICH CAUSED BLEEDING. THE PATIENT WAS PROVIDED WITH ANOTHER PCB00 LENS. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE BLEEDING WAS IN THE ANTERIOR CHAMBER AND NO INTERVENTIONS WERE NECESSARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hyphema

  MAUDE report 9955146 ↗
• InjuryJan 9, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE WHILE INSERTING THE LENS INTO THE PATIENT¿S RIGHT EYE. THE LENS HAD CONTACT WITH THE EYE. HANDLING PROBLEM/USE ERROR WAS INDICATED. AN INCISION ENLARGEMENT WAS REQUIRED, AND ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9571975 ↗
• InjuryDec 26, 2019Unintended Movement; Separation Problem; Unintended Movement; Separation Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD HAPTIC MISSING. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WHEN THE PCB00 LENS WAS IMPLANTED INTO THE EYE, THEY NOTICED THAT ONE HAPTIC MAY BE MISSING. AFTER THREE TO FOUR WEEKS, PATIENT CAME BACK AS THE LENS WAS NOT STAYING IN POSITION PROPERLY, THE LENS WAS EXPLANTED/EXCHANGED. THE PATIENT WAS WORRIED, BUT SURGERY WAS UNCOMPLICATED. THERE WAS NO SUTURE OR VITRECTOMY, HOWEVER, AN INCISION ENLARGEMENT WAS REQUIRED. ALSO NOTED IS NEURO-128 ONGUENT WAS PRESCRIBED BY DOCTOR DUE TO CORNEAL EDEMA PERSISTENT ONE-MONTH POST-OP. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/200. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/200. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/70 (ONE MONTH POST FIRST SURGERY). NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 9522337 ↗
• MalfunctionNov 22, 2019Contamination; Contamination

  IT HAS BEEN REPORTED THAT AFTER A PERFECT PREPARATION AND IMPLANTATION, THE DOCTOR THOUGHT THAT SHE SAW A LENS COLOURED PARTICLE. SHE GOT IT OUT OF THE EYE BY IRRIGATING/ASPIRATING. NO PATIENT INJURY, NO WOUND ENLARGEMENT. THE PARTICLE COULD NOT BE COLLECTED. THE LENS REMAINS IMPLANTED. NO SECONDARY SURGERY OR MEDICAL INTERVENTION HAS BEEN REQUIRED. NO DELAY IN PROCEDURE. ALL INFORMATION AVAILABLE HAS BEEN SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365941 ↗
• MalfunctionNov 7, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING THE INSERTION OF THE LENS, WIRES WERE DISCOVERED ON THE LENS LAST WEEK. DR DE LINT WAS ABLE TO REMOVE IT WHEN THE LENS HAD UNFOLDED. THE SURGEON DOES NOT KNOW IF THIS CAME FROM THE SHOOTER OR SOMEWHERE ELSE. THROUGH FOLLOW-UP WE LEARNED THAT 4 VERY THIN NYLON (?) THREADS WERE OBSERVED AND REMOVED FROM THE LENS AFTER IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289468 ↗
• MalfunctionSep 22, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCBOO INTRAOCULAR LENS (IOL) WAS STUCK IN THE PRELOADED INSERTER AND PARTIALLY DELIVERED IN THE PATIENT'S EYE. THE LENS WAS REMOVED AND ANOTHER LENS WAS INSERTED SUCCESSFULLY WITHOUT FURTHER ISSUE. THERE WAS NO HARM TO THE PATIENT. CUSTOMER ALSO INDICATED THAT THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101442 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) OPERATIVE EYE ON (B)(6) 2019 AND WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO AN UNSPECIFIED INJURY. PATIENT REPORTEDLY HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8563281 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT SURGEON CREATED VITRECTOMY AND DID LENS EXCHANGE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT A CAPSULAR TEAR OCCURRED AND LENS WAS REMOVED AND REPLACED IN THE SAME SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8255662 ↗
• MalfunctionOct 4, 2018Improper or Incorrect Procedure or Method; Failure to Eject; Improper or Incorrect Procedure or Method; Failure to Eject

  IT WAS REPORTED THAT THERE WAS A LOADING ERROR WITH THE PRELOADED INTRAOCULAR LENS (MODEL PCB00). REPORTEDLY, THE LENS TOUCHED THE PATIENT'S OPERATIVE EYE BUT DID NOT EJECT FROM THE CARTRIDGE. NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7933288 ↗
• MalfunctionMay 4, 2018Crack; Crack

  IT WAS REPORTED THAT THE TIP OF A CARTRIDGE ON A PCB00 PRELOADED DEVICE CRACKED AS THE LENS PASSED THROUGH INTO THE PATIENT'S RIGHT EYE DURING IMPLANTATION. REPORTEDLY, THIS DID NOT AFFECT DELIVERY OF THE LENS AND THE LENS REMAINS IMPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488987 ↗
• InjuryJan 17, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL PCB00, +26.5 DIOPTER) WAS REMOVED FROM THE EYE AFTER INSERTION DUE TO A CAPSULAR TEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE DOCTOR HAD TO PERFORM A VITRECTOMY AND AN INCISION ENLARGEMENT WAS REQUIRED. THE REPLACEMENT LENS WAS A NON-AMO INTRAOCULAR LENS. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7202897 ↗
• InjuryDec 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PCB00 26.5 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 INTO THE PATIENT'S RIGHT EYE (OD). IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A DIOPTER ERROR. REPORTEDLY SUTURES WERE REQUIRED AND ANOTHER LENS OF THE SAME MODEL WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7103000 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO HAVING SUB-OPTIMAL VISION DUE TO REFRACTIVE ERROR. THE PATIENT'S REFRACTION RESULTS WERE -2.25 X +1.00 X 150 DEGREES 20/20. REPORTEDLY, THERE WAS AN INCISION ENLARGEMENT AND ONE SUTURE USED, BUT NO VITRECTOMY. THE LENS WAS REPLACED WITH A ZCT150 24.5 IOL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6950302 ↗
• MalfunctionJun 30, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IN THE EYE HALF WAY AND GOT STUCK IN THE CARTRIDGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6681960 ↗
• MalfunctionMar 14, 2017Sticking; Sticking

  IT WAS REPORTED THAT DURING THE IMPLANTATION AND DEPLOYMENT OF THE INTRAOCULAR LENS (IOL), THE POSTERIOR HAPTICS BECAME STUCK UNDER THE OPTIC. THE HAPTICS HAD TO BE LIFTED WITH THE SUCTION FLUSHING CANNULAS. THE PATIENT WAS NOT HARMED. THE IOL WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6404842 ↗
• MalfunctionFeb 9, 2017Sticking; Sticking

  IT WAS NOTICED THAT THE HAPTICS GOT STUCK TO THE POSTERIOR PART OF THE OPTIC. THE LENS WAS IMPLANTED. THERE WAS A DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY. INITIALLY THREE LENSES WERE REPORTED AS IMPACTED BY THE SAME ISSUE. THIS REPORT CAPTURES THE EVENT FOR #2 OF 3. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6313372 ↗