TECNIS IOL PCB00 (REF PCB0000155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474558175), received between Oct 11, 2016 and Sep 13, 2021 — classified as 4 injuries, 22 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Break; Break

  IT WAS REPORTED THAT THE LENS WAS FAULTY. IT IS UNKNOWN IF THERE WAS A PATIENT CONTACT. NO PATIENT INJURY WAS REPORTED. THE MATERIAL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465284 ↗
• MalfunctionAug 20, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) MISFIRED WHILE PHYSICIAN WAS USING IT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349511 ↗
• MalfunctionJan 7, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DROPPED OR WAS A DAMAGED LENS. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THE CUSTOMER NO LONGER HAD ANY INFORMATION AVAILABLE AS ALL THE INFORMATION WAS ON THE LENS BOX THAT WAS RETURNED BACK TO JOHNSON & JOHNSON SURGICAL VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11129208 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL PCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF RESIDUAL ASTIGMATISM AND DECREASED VISUAL ACUITY. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL BUT SAME DIOPTER LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10865614 ↗
• MalfunctionNov 11, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 PRELOADED INSERTION DEVICE HAD LOADING ISSUE/DEFECTIVE INSERTER. IT WAS STATED THAT THERE WAS PATIENT CONTACT AND THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED. A BACK-UP IOL OF THE SAME MODEL AND SAME DIOPTER WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9307787 ↗
• MalfunctionAug 12, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED PCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) THE DOCTOR WAS ONLY ABLE TO SCREW/INSERT ¾ OF THE LENS INTO THE PATIENT¿S OPERATIVE EYE AS THE LENS WOULD NOT COME ALL THE WAY OUT OF THE CARTRIDGE. THE LENS AND CARTRIDGE WERE REMOVED, AND BACK-UP LENS WAS INSERTED WITHOUT ANY DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884053 ↗
• InjuryJul 31, 2019Break; Break

  IT WAS REPORTED THAT A PCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE DUE TO A BROKEN HAPTIC. INCISION WAS ENLARGED, BUT NO HARM OR INJURY TO THE PATIENT. REPORTEDLY, PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8844419 ↗
• MalfunctionMar 8, 2019Crack; Crack

  IT WAS REPORTED THAT A PCB00 INJECTOR WAS NOTICED CRACKED WHEN REMOVING FROM PACKAGING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8406143 ↗
• MalfunctionMar 4, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A NOTCH IN THE LENS. THE IOL WAS CUT OUT, REMOVED DURING THE SAME PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387420 ↗
• MalfunctionJan 21, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF A PCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS FOUND DISTORTED AND IT WAS OUT WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE IOL WAS NOT FULLY INSERTED. THERE WAS PATIENT CONTACT; HOWEVER, NO HARM TO THE PATIENT WAS REPORTED. IT WAS NOTED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AND THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8263528 ↗
• MalfunctionNov 7, 2018Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) HAPTIC TIPS STUCK TOGETHER TO THE INTERIOR PART OF THE IOL. IT REQUIRED THE SURGEON TO ENTER THE EYE TWO OR THREE TIMES MORE WITH EXTRA INSTRUMENTS TO TRY TO UN-PRY THE HAPTICS WHICH HE ULTIMATELY DID. THERE WAS NO PATIENT INJURY OR SUTURE OR INCISION ENLARGEMENT. IT WAS STATED THAT THE PATIENT OUTCOME WAS GOOD BUT THE CUSTOMER NEEDED TO REPORT THE EVENT AS DIRECTIONS FOR USE (DFU) WAS FOLLOWED PERFECTLY YET HAPTICS STILL STUCK TOGETHER AND IT TOOK A WHILE FOR THE SURGEON TO UNSTICK THE HAPTICS. FURTHER FOLLOW-UP CONFIRMED THAT WITH THIS PRODUCT, THE COMPLAINT OF STICKING HAPTICS WASN¿T NOTICED UNTIL THE PRODUCT WAS IN THE EYE. SINCE THE IMPLANTED IOL WASN¿T DAMAGED, THE CUSTOMER DECIDED TO USE IT. THERE WAS NO BACKUP IOL NEEDED. IT WAS NOTED THAT THE PATIENT IS A (B)(6) YEAR OLD, FEMALE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8049622 ↗
• MalfunctionJul 30, 2018Break; Break

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED DELIVERY SYSTEM (MODEL PCB00) WAS BROKEN DURING HANDLING, BUT PRIOR TO USE. NO PATIENT CONTACT WAS REPORTED. A BACKUP PCB00 LENS (SAME DIOPTER SIZE) WAS IMPLANTED SUCCESSFULLY DURING THE SAME PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7730569 ↗
• MalfunctionApr 14, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT UPON INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE, THE DOCTOR NOTICED A SCRATCH ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE WITHOUT INCIDENT. PER THE ACCOUNT THERE WAS AN OVERRIDE ISSUE BUT WAS UNSURE IF THE SCRATCHED LENS WAS A RESULT OF IT. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7431522 ↗
• MalfunctionMar 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A LINT WAS NOTICED ON THE CENTER OF THE ANTERIOR PORTION OF AN INTRAOCULAR LENS (IOL) DURING IMPLANTATION IN THE LEFT EYE OF A MALE PATIENT. REPORTEDLY, THE SURGEON MANAGED TO REMOVE THE LINT USING A SINSKY HOOK. 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 7305531 ↗
• MalfunctionFeb 20, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE BACK HAPTIC GOT STUCK IN THE CARTRIDGE AS THE CARTRIDGE WAS BEING PULLED OUT. REPORTEDLY, THE WHOLE LENS GOT STUCK IN THE CARTRIDGE. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT POST-OP INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7284134 ↗
• MalfunctionFeb 7, 2018Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF A PCB00 15.5 DIOPTER PRE-LOADED 1-PIECE INTRAOCULAR LENS (IOL) WAS NOTICED CRACKED DURING HANDLING AND PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7250137 ↗
• InjuryJan 5, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) UNFOLDED IN THE RIGHT EYE, THERE WAS A FULL THICKNESS BREAK IN IT FROM THE OPTIC EDGE TO THE TRAILING HAPTIC THAT THE SURGEON SUSPECTS HAPPENED WHEN THE IOL WAS ADVANCED IN THE CARTRIDGE. HE HAD TO CUT THE IOL OUT AND INSERT ANOTHER ONE DURING THE SAME PROCEDURE. THE DOCTOR USED WOUND ASSISTED TECHNIQUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. THERE WAS INCISION ENLARGEMENT. NO SUTURES REQUIRED. NO VITRECTOMY. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 7166899 ↗
• MalfunctionOct 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSERTION OF THE INTRAOCULAR LENS (IOL) UNDER THE SURGICAL MICROSCOPE, THE DOCTOR NOTICED THAT THE TIP OF THE INSERTER (MOUTH) WAS BLUNT AND DEFORMED (DAMAGED). THE SURGERY WAS NORMALLY PERFORMED. AS THE TIP OF THE INSERTION TIP APPEARED TO BE BENT, SHE REJECTED THE PRODUCT AND USED ANOTHER DEVICE OF THE SAME MODEL. PROVISC WAS USED AS VISCOELASTIC. THERE WAS NO PATIENT CONTACT WITH THE IOL. NO ADVERSE EVENT. NO SECONDARY SURGERY/MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6933188 ↗
• MalfunctionOct 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER INSERTION OF THE INTRAOCULAR LENS (IOL) UNDER THE SURGICAL MICROSCOPE, THE DOCTOR NOTICED 1 LONGITUDINAL PLASTIC-LIKE PIECE STUCK ALONG THE HAPTIC OF THE LENS. SHE TRIED TO ASPIRATE IT AND WAS FINALLY ABLE TO PULL IT OUT FROM THE PARACENTESIS INCISION. THE DOCTOR WAS NOT ABLE TO KEEP IT. THE SURGERY WAS NORMALLY PERFORMED AFTERWARDS. PROVISC WAS USED AS VISCOELASTIC. THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT HARM. NO SECONDARY SURGERY/MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930229 ↗
• MalfunctionSep 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARTRIDGE TIP WAS DEFORMED AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT/INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6867574 ↗
• MalfunctionJun 16, 2017Break; Break

  IT WAS REPORTED THAT THE PLUNGER OF A PRELOADED DELIVERY SYSTEM, MODEL PCB00, BROKE THROUGH THE SIDE OF THE CARTRIDGE TIP BEFORE THE INTRAOCULAR LENS (IOL) WAS INJECTED. REPORTEDLY, THE SURGEON THEN USED A ZCB00 LENS INSTEAD. THE PATIENT WAS NOT HARMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645923 ↗
• MalfunctionJun 7, 2017Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LOCKED UP AND DAMAGED THE CARTRIDGE TIP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6620676 ↗
• MalfunctionJun 2, 2017Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE CRACKED. DURING FOLLOW UP, IT WAS FOUND THAT THE CARTRIDGE TIP CRACKED BEFORE ANY PATIENT CONTACT AND WHILE THE TECH WAS LOADING. NO PATIENT CONTACT OR INJURY NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6609849 ↗
• MalfunctionApr 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER THE SECOND STEP, THE CARTRIDGE OF THE PRELOADED DEVICE DIDN¿T SEEM RIGHT. THE USER SAW AN EXTRA PIECE OF PLASTIC AT THE END OF THE CARTRIDGE. IT WAS REPORTED THAT THIS COULD CAUSE A TEAR IN THE CAPSULAR BAG. THEREFORE, THE SURGEON DECIDED NOT TO IMPLANT THE INTRAOCULAR LENS (IOL) AND TOOK ANOTHER ONE. THERE WAS NO PATIENT INJURY OR ENLARGEMENT OF THE WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6487720 ↗
• InjuryMar 6, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING IMPLANTATION, AN INTRAOCULAR LENS (IOL) UNFOLDED IN THE EYE WITHOUT THE TRAILING HAPTIC. REPORTEDLY, THE TRAILING HAPTIC REMAINED IN THE CARTRIDGE. THE LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATIONS WITH A NEW LENS, SAME MODEL. A DELAY OF 30 MINUTES IN THE PROCEDURE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE INCISION WAS ENLARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6383031 ↗