TECNIS IOL PCB00 (REF PCB0000160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05050474558182), received between Nov 2, 2016 and Jul 28, 2023 — classified as 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 28 reports, in the reporter's own words as published by the FDA.

• 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 17414785 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THAT TWO INTRAOCULAR LENSES WERE LEFT BY A VISITING COMPANY USED BY THE (B)(6) SO DESCRIPTION OF INCIDENT WAS WRITTEN ON THE LENS BOX. ONE IS DESCRIBED SIMPLY AS BROKEN. THE OTHER SAYS BROKEN AND PROBLEM WITH HAPTIC. THROUGH FOLLOW-UPS, IT IS UNCLEAR WHICH LENS WAS DESCRIBED AS PROBLEM WITH HAPTIC IN ADDITION TO BEING DESCRIBED AS BROKEN. NO PATIENT INJURY WAS REPORTED. THEREFORE, DESPITE SEVERAL ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR #2 OF THE 2 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637192 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT A MODEL PCB00 INTRAOCULAR LENS(IOL) WAS DEFECTIVE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451922 ↗
• MalfunctionJul 15, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION A PCB00 INTRAOCULAR LENS (IOL) HAD FOLDING ISSUES AND A BENT/BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174704 ↗
• MalfunctionAug 4, 2020Device Markings/Labelling Problem; Failure to Eject; Device Markings/Labelling Problem; Failure to Eject

  IT WAS REPORTED THAT THE REAR HAPTIC OF THE LENS GOT STUCK DURING THE IMPLANTATION. THIS DID NOT LEAD TO ANY PATIENT ISSUES. THE CUSTOMER ALSO QUESTIONS THE LABELING-SERIAL NUMBER. THE UNIT ITSELF SHOWS SERIAL NUMBER (B)(4) WHICH CORRESPONDS TO THE STICKER ON THE SIDE OF THE BOX. THE MAIN BODY OF THE BOX HOWEVER SHOWS SERIAL NUMBER (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363118 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL PCB00 16.0 DIOPTER INTRAOCULAR LENS WAS INSERTED INTO THE PATIENT'S EYE BUT WAS THEN REMOVED AND CHANGED AFTER A VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 9339603 ↗
• MalfunctionMay 31, 2019Failure to Unfold or Unwrap; Separation Problem; Failure to Unfold or Unwrap; Separation Problem

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS HAD UNFOLDING ISSUE AND A MISSING HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8657069 ↗
• MalfunctionApr 23, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PRELOADED PLUNGER DID NOT PUSH IN PROPERLY AND THEREFORE DID NOT PUSH THE LENS OUT PROPERLY ACCORDING TO SURGEON. LENS ARM (HAPTIC) WAS REPORTEDLY STUCK IN CHAMBER. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE CARTRIDGE TIP AND THE TIP OF THE LENS ARM WERE IN CONTACT WITH THE PATIENT¿S EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8542242 ↗
• MalfunctionApr 17, 2019Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS HAD PACKAGING ISSUE AND THE PRODUCT WAS RECEIVED DAMAGED PRODUCT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE BOTH THE OUTER BOX AND LENS WAS DAMAGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Weakness

  MAUDE report 8525639 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT THE LUMEN/TIP OF THE CARTRIDGE WAS DAMAGED AND THE INTRAOCULAR LENS DIDN'T EXIT THE DELIVERY SYSTEM. THIS HAPPENED DURING HANDLING BUT PRIOR TO INSERTION INTO THE EYE. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8420255 ↗
• InjuryMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS WAS BROKEN WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, IT WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED, BUT A VITRECTOMY, WAS PERFORMED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8410373 ↗
• InjuryMar 7, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT A SECOND ATTEMPT TO IMPLANT AN INTRAOCULAR LENS WAS UNSUCCESSFUL LIKE THE FIRST AND THE HAPTIC OF AN INTRAOCULAR LENS BECAME DETACHED AND INVOLVED PATIENT CONTACT. THE LENS WAS CUT OUT OF THE EYE, A VITRECTOMY WAS PERFORMED AGAIN, AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS TRIED, BUT UNSUCCESSFUL AGAIN HAVING THE SAME HAPTIC DETACHED ISSUE. THEREFORE, THE DOCTOR CHANGED THE MODEL TO A ZCB00 AND IMPLANTED THAT SUCCESSFULLY. REPORTEDLY, THE PATIENT DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE SECOND OF TWO INTRAOCULAR LENS USED ON THE SAME PATIENT. A SEPARATE REPORT WILL CAPTURE THE FIRST INTRAOCULAR LENS USED ON THE PATIENT. AFTER BOTH THESE INTRAOCULAR LENSES WERE TRIED, A THIRD ATTEMPT WAS TRIED WITH MODEL ZCB00 AND HAD NO ISSUES OR COMPLICATIONS. (JN (B)(6) 2019).

  Patient problems: Vitrectomy

  MAUDE report 8402253 ↗
• InjuryMar 7, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS BECAME DETACHED AND INVOLVED PATIENT CONTACT. THE LENS WAS CUT OUT OF THE EYE, A VITRECTOMY WAS PERFORMED, AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS TRIED. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE FIRST OF TWO INTRAOCULAR LENS USED ON THE SAME PATIENT. A SEPARATE REPORT WILL CAPTURE THE SECOND INTRAOCULAR LENS USED ON THE PATIENT. AFTER BOTH OF THESE INTRAOCULAR LENSES WERE TRIED, A THIRD ATTEMPT WAS TRIED WITH A MODEL ZCB00 LENS. WITH THIS THIRD LENS THERE WERE NO ISSUES OR COMPLICATIONS.

  Patient problems: Vitrectomy

  MAUDE report 8402242 ↗
• MalfunctionFeb 20, 2019Material Split, Cut or Torn; Failure to Eject; Material Split, Cut or Torn; Failure to Eject

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED DELIVERY SYSTEM (MODEL PCB00) WAS SPLIT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE. THERE WAS PATIENT CONTACT BUT NO INJURY OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS STUCK IN THE CARTRIDGE AND IT WAS PARTIALLY DELIVERED INTO THE EYE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354410 ↗
• MalfunctionJan 6, 2019Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF MODEL PCB00 INTRAOCULAR LENS (IOL) WAS BROKEN AFTER BEING INSERTED IN PATIENT'S EYE. THE LENS HAD TO BE CUT OUT OF THE ANTERIOR CHAMBER (AC) AND REPLACED WITH NEW LENS. THERE WERE NO PATIENT ISSUES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8220632 ↗
• MalfunctionOct 26, 2018Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS), A PART OF THE OPTIC WAS NOTICED TO BE MISSING AS IT CAME OUT FROM THE INSERTER. REPORTEDLY, THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009395 ↗
• MalfunctionAug 6, 2018Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PREPARED PERFECTLY. DURING IMPLANTATION, THE LENS WAS INSERTER INTO THE PATIENT'S OPERATIVE EYE BUT THE TRAILING HAPTIC GOT STUCK IN THE CARTRIDGE. WITH THE MCPHERSON PINCET THE HAPTIC WAS RELEASED BUT IN THE MEANTIME THE LENS WAS TURNED. REPORTEDLY, THE SURGEON MANAGED TO TURN OVER THE LENS IN THE EYE. THE LENS REMAINS IMPLANTED. NO PATIENT INJURY NO WOUND ENLARGEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7751068 ↗
• MalfunctionJun 18, 2018Difficult or Delayed Positioning; Torn Material; Difficult or Delayed Positioning; Torn Material

  IT WAS REPORTED THAT DURING THE INJECTION OF A PCB00 INTRAOCULAR LENS (IOL), THERE WAS RESISTANCE DURING USE AND WHEN INJECTED THE IOL WAS RIPPED ON THE OPTIC EDGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Information

  MAUDE report 7608709 ↗
• MalfunctionApr 25, 2018Crack; Crack

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS HAD CARTRIDGE TIP BROKEN OBSERVED WHEN PACKAGE WAS OPENED. IT WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7463051 ↗
• MalfunctionApr 13, 2018Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT PLUNGER FAILED TO ADVANCE (INTRAOCULAR LENS) IOL COMPLETELY WHEN INSERTING INTO THE EYE. THERE WAS PATIENT CONTACT AND IOL WAS PARTIALLY DELIVERED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431502 ↗
• InjuryMar 30, 2018Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION, THE INTRAOCULAR LENS(IOL) CAME OUT OF THE CARTRIDGE WITHOUT THE TRAILING HAPTIC. THE HAPTIC/OPTIC TOUCHED THE PATIENT'S EYE. THE PATIENT EXPERIENCED DOUBLE VISION AFTER THE SURGERY; THEREFORE, THE IOL WAS EXPLANTED AND REPLACED WITH A NEW IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC

  Patient problems: No Code Available

  MAUDE report 7387418 ↗
• MalfunctionNov 21, 2017Split; Split

  IT WAS REPORTED THAT A PCB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) SPLIT WHILE BEING IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7047766 ↗
• MalfunctionOct 7, 2017Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) DID NOT DEPLOY PROPERLY AS THERE WAS DAMAGE TO END OF THE CARTRIDGE. THERE WAS NO PATIENT IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927541 ↗
• InjurySep 11, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND APPEARED GOUGED. THE SURGEON SAID THAT IT FELT A LITTLE HARDER THAN USUAL TO TURN THE SCREW OF THE LENS DELIVERY SYSTEM. THE END RESULT WAS THAT THE IOL WAS REMOVED FROM THE EYE AFTER THE SURGEON CUT IT INTO 3 PIECES. THE INCISION WAS ENLARGED SLIGHTLY. THERE WAS NO VITREOUS/VITRECTOMY AND NO SUTURES WERE NEEDED TO SEAL THE INCISION AFTER A SECOND LENS WAS IMPLANTED. FURTHER INFORMATION WAS PROVIDED AND NOTED THAT WHAT MAY HAVE CAUSED THE EVENT, WAS THERE WAS NOT ENOUGH VISCOELASTIC IN THE VERY BACK OF THE CARTRIDGE AND THE LENS STUCK AND THE PLUNGER ENDED UP DIGGING INTO THE OPTIC. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6854299 ↗
• MalfunctionAug 14, 2017Break; Break

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, THE CARTRIDGE TIP OF A PRELOADED DELIVERY SYSTEM (MODEL PCB00) WAS NOTICED DAMAGED AND IT HAD A WEIRD SHAPE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO PATIENT CONTACT WITH THE INTRAOCULAR LENS (IOL). NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6793438 ↗