TECNIS IOL PCB00 (REF PCB0000135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474558137), received between Oct 3, 2016 and Mar 25, 2024 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 21, 2018Terminated

   Expired intraocular lenses were distributed.

   Z-0464-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968571 ↗
• MalfunctionOct 9, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THE SURGEON NOTICED IT WAS CRACKED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. IT IS ALSO UNKNOWN IF THE LENS WAS REMOVED AND REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17900522 ↗
• MalfunctionMay 3, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MARK ON THE CENTER OF AN INTRAOCULAR LENS (IOL) WAS FOUND ONCE THE IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. THE ACCOUNT THINKS IT WAS FROM THE LENS PLUNGER. THE IOL WAS EXPLANTED DURING THE SAME PROCEDURE AND REPLACED WITH A NEW LENS. THROUGH FOLLOW UP THE ACCOUNT CONFIRMED THAT ALL STAFF HAVE BEEN TRAINED, NO REPORT OF LENS PREPARATION NOT BEING FOLLOWED WAS INDICATED AND NO USE ERROR WAS REPORTED. IT WAS REPORTED THAT THERE WAS A DELAY IN LENGTH OF THE SURGERY AND DISCOMFORT TO PATIENT WAS NOTED. THERE WAS NO VITRECTOMY REQUIRED AND NO CONCERNS WERE RAISED WITH REGARDS TO DAILY ACTIVITIES OF PATIENT BEING AFFECTED. THERE WAS NO PATIENT HARM REPORTED POST LENS REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Pain

  MAUDE report 14265923 ↗
• InjuryDec 15, 2021Device Difficult to Setup or Prepare; Inaccurate Delivery; Device Difficult to Setup or Prepare; Inaccurate Delivery

  IT WAS REPORTED THAT THE DOCTOR ENCOUNTERED ISSUE WITH THE INJECTOR ON THE MAIN PRELOADED INTRAOCULAR LENS (PCB00). THERE WAS PROBLEM WITH THE LOADING AND DELIVERY OF THE LENS INTO PATIENT'S EYE. THE DOCTOR THEN PROCEEDED WITH A 3-PIECE (ZA9003) LENS INSERTION AND FOUND THAT THE LENS HAPTIC BROKE ONCE IT WAS INJECTED INTO THE PATIENT'S EYE. THE 3-PIECE LENS WAS THEN REMOVED FROM THE PATIENT'S EYE AND THE PATIENT WAS LEFT APHAKIC. THE DOCTOR INFORMED THAT THE PATIENT WILL NEED TO HAVE A 3-PIECE LENS FOR SULCUS IMPLANTATION AS A REPLACEMENT LENS. BASED ON ADDITIONAL INFORMATION RECEIVED, THE PRELOADED LENS WAS DIFFICULT TO USE AS THE MOVEMENT OF THE LENS FORWARD TO THE CARTRIDGE TIP WAS NOT SMOOTH. IT WAS STUCK AND THEN THE LENS PLUNGED FORWARD WHICH CAUSED A POSTERIOR CAPSULE RUPTURE IN THE PATIENT. THE LENS WAS FULLY INSERTED INTO THE CAPSULAR BAG BUT PIERCED THROUGH THE BAG DUE TO THE FAULTY DELIVERY MECHANISM. IT WAS THEN REMOVED. ONLY THE LENS MADE CONTACT WITH THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO THE EVENT WITH THE PCB00 PRELOADED INTRAOCULAR LENS. A SEPARATE REPORT WAS ALREADY SUBMITTED FOR THE EVENT RELATED TO THE ZA9003 3-PIECE

  Patient problems: Capsular Bag Tear

  MAUDE report 13015475 ↗
• MalfunctionJun 22, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) PRE INJECTED OUTSIDE THE EYE, HOWEVER, THE LENS TIP HAD CONTACTED PATIENT'S RIGHT EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044253 ↗
• InjuryJun 17, 2021Material Fragmentation; Material Fragmentation

  CUSTOMER REPORTED AFTER ENTERING THE OPTIC ZONE OF THE ANTERIOR CAMARA; IT WAS OBSERVED THE SECOND HAPTIC WAS AMPUTATED, INSIDE THE CARTRIDGE OF THE IMPLANT. THEY CHOSE ON MAINTAINING THE LENS IN CAPSULAR BAG FOR LATER REPLACEMENT, AS THERE WAS NO OTHER INTRAOCULAR LENS (IOL) WITH THE SAME DIOPTER AVAILABLE AT THAT MOMENT. MEDICATION WAS PRESCRIBED (VIGADEXA). PRE-OP VISION: 20/60; POST-OP VISION: 20/70. THE EXPLANT WAS PLANNED BUT DID NOT OCCUR. INCISION WAS AMPLIFIED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 12021764 ↗
• MalfunctionFeb 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) APPEARS TO HAVE A CRACK THAT WAS ONLY EVIDENT AFTER LENS WAS INSERTED AND UNFOLDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS A CRACK AT THE HAPTIC OPTIC JUNCTION, BUT THE HAPTIC REMAINED IN GOOD POSITION; THEREFORE, THE SURGEON LEFT THE LENS IMPLANTED. THE PATIENT IS DOING VERY WELL. COMPLAINING OF DYSPHOTOPSIAS. UNCORRECTED VISION IS FINE AND LENS IS SITTING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11341279 ↗
• MalfunctionAug 5, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT WHILE LENS WAS BEING INSERTED INTO THE PATIENT¿S LEFT EYE, THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED, THE LENS GOT STUCK IN CARTRIDGE. THE BACK-UP IOL OF SAME MODEL AND DIOPTER WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10368419 ↗
• MalfunctionFeb 8, 2019Break; Break

  IT WAS REPORTED THAT A PCB00 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED. IT IS UNKNOWN IF THE LENS WAS DAMAGED WHEN REMOVED FROM THE PACKAGING OR DURING PRODUCT HANDLING. THERE IS NO INDICATION OF HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8322845 ↗
• MalfunctionJan 16, 2019Break; Crack; Break; Crack

  IT WAS REPORTED THAT MODEL PCB00 CARTRIDGE WAS DAMAGED, CARTRIDGE TIP WAS OBSERVED CRACK. THE ISSUE WAS FIRST NOTICED WHILE SCREWING THE LENS INTO PATIENT'S EYE. REPORTEDLY, THE LENS CAME OUT ALRIGHT AND THERE WAS NO INTERVENTION REQUIRED. THERE WAS NO INCISION ENLARGEMENT REQUIRED NOR PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254434 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THAT CARTRIDGE TIP OF PCB00 MONOFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED DAMAGE DURING HANDLING. IT WAS NOTED THAT THERE WAS NO PATIENT CONTACT IN HER LEFT EYE (OS) WITH THE DAMAGED CARTRIDGE TIP AS NON-JOHNSON & JOHNSON INJECTOR WAS USED TO COMPLETE PROCEDURE WITH A BACK-UP LENS (PCB00 13.5 DIOPTER) INSTEAD. PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832691 ↗
• MalfunctionAug 7, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  A PRE-LOADED IOL WAS EVALUATED AND FOUND THERE WAS DENT/DISTORTION OBSERVED AT THE CARTRIDGE TIP SECTION. LENS WAS ALSO OBSERVED DAMAGED AND STUCK IN CARTRIDGE. INITIALLY, IT WAS REPORTED THAT A PCB00 3.5 DIOPTER LENS SHOT OUT OF THE INSERTION SYSTEM BEFORE ENTERING THE PATIENT''S OPERATIVE EYE. REPORTEDLY, THERE WAS NO PATIENT CONTACT, AND THIS OCCURRED DURING HANDLING AND PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7759943 ↗
• InjuryApr 23, 2018Crack; Torn Material; Crack; Torn Material

  IT WAS REPORTED THAT THE PCB00 INTRAOCULAR LENS (IOL) WAS CRACKED WITH TORN HAPTIC WHEN INSERTING INTO THE EYE. THERE WAS PATIENT CONTACT, BUT NO INJURY OCCURRED. THE PHYSICIAN PERFORMED AN INCISION ENLARGEMENT AND A SUTURE WAS USED. THERE WAS NO PATIENT ANATOMY ISSUE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7451734 ↗
• MalfunctionMar 6, 2018Break; Break

  IT WAS REPORTED THAT THE PLUNGER COULD BE MOVED NORMALLY DURING IMPLANTATION. HOWEVER, AFTER IMPLANTATION, WHEN THE INTRAOCULAR LENS (IOL) OPENED / UNFOLDED, THERE WAS A MAJOR DEFECT ON THE IOL SURFACE/OPTIC. THE SURGEON HAD TO REMOVE THE IOL AND IMPLANT A NEW ONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319431 ↗
• MalfunctionNov 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOPHTHALMITIS IN THE RIGHT EYE AFTER INTRAOCULAR LENS (IOL) IMPLANT ON OCTOBER 18, 2017. THE PATIENT HAD A VITRECTOMY ON (B)(6) 2017. IT WAS REPORTED THAT THE OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Endophthalmitis; Vitrectomy

  MAUDE report 7057354 ↗
• MalfunctionAug 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE OF FEMALE PATIENT, WHITE PARTICULATE WAS OBSERVED STUCK ON THE OPTIC OF THE LENS. REPORTEDLY, THE LENS WAS IMPLANTED AND THE WHITE PARTICULATE WAS REMOVED DURING THE IRRIGATION/ASPIRATION (I/A) PROCEDURE. THERE WAS A 2-MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. THE SURGEON INJECTED VIGAMOX INTRACAMERAL AS A PREVENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778966 ↗
• MalfunctionMar 29, 2017Break; Break

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A DEFECT, A LITTLE MISSING PIECE, WAS NOTICED IN THE MIDDLE OF THE OPTIC. THE LENS WAS CUT IN TWO PARTS AND REMOVED AND REPLACED WITH ANOTHER PCB00, SAME DIOPTER, DURING THE SAME SURGICAL PROCEDURE. THE MISSING LITTLE PIECE WAS ALSO REMOVED FROM THE EYE. REPORTEDLY, THE LENS LOADING WAS PERFORMED ACCORDING TO THE STANDARD PROCEDURE USING BSS (BALANCE SALT SOLUTION) AND VISCOELASTIC. THERE WERE ABOUT 10 MINUTES DELAY IN THE PROCEDURE. NO INCISION ENLARGEMENT WAS REPORTED. NO PROBLEMS WERE FOUND ONE DAY POST-OP. NO FURTHER INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6443384 ↗
• MalfunctionNov 7, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED IN THE CARTRIDGE DURING THE IMPLANTATION INTO THE LEFT EYE OF A FEMALE PATIENT. THE PLUNGER DAMAGED THE EDGE OF OPTIC. THE SURGEON DECIDED TO LEAVE THE IOL IMPLANTED INTO THE EYE. THE PATIENT WAS SEEN FOUR (4) DAYS POST OP AND IT WAS REPORTED THAT THE DAMAGED EDGE OF THE OPTIC WAS COVERED BY THE IRIS AND DID NOT AFFECT THE QUALITY OF HER VISION. THE PATIENT OUTCOME WAS REPORTED AS SATISFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6082078 ↗
• MalfunctionOct 6, 2016Wrinkled; Wrinkled

  DURING SURGERY AND AFTER PERFECTLY FOLLOWING THE STEPS FOR THE CORRECT IMPLANTATION OF THE LENS, THE LAST STEP WAS PERFORMED AND THE LENS DID NOT COME OUT, INSTEAD, IT REMAINS CREASED IN ONE OF THE CARTRIDGE SIDES. NO PATIENT INVOLVEMENT/INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6004738 ↗
• InjuryOct 3, 2016Device Operates Differently Than Expected; Device Handling Problem; Device Operates Differently Than Expected; Device Handling Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOADING ISSUE WHILE INSERTING LENS INTO THE EYE. THE CARTRIDGE WAS NOT FAR ENOUGH INTO THE EYE BEFORE EXPRESSING THE PLUNGER. THE LENS WAS REMOVED AND INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 5995251 ↗