TECNIS IOL PCB00 (REF PCB0000170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 05050474558205), received between Oct 11, 2016 and Apr 18, 2023 — classified as 12 injuries, 29 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) BROKE DURING HANDLING, BUT PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL (THE DIOPTER WAS NOT PROVIDED). IT WAS INDICATED THAT THE INNER POUCH WAS NOT OPENED/UN-SEALED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759088 ↗
• MalfunctionSep 13, 2022Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery

  IT WAS REPORTED THAT WHEN THE PHYSICIAN INTRODUCED THE LENS INTO THE PATIENT'S EYE, PART OF ONE HAPTIC GOT STUCK IN THE INTRODUCER. IT DETACHED AND REMAINED IN THE UNIT BUT THE LENS WAS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS REMAINS IMPLANTED, IT IS MISSING ONE HAPTIC WHICH THE SURGEON THINKS WILL NOT BE AN ISSUE. NO SURGICAL INTERVENTION WHERE REQUIRED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411401 ↗
• 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 #1 OF THE 2 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE SECOND PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637179 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT WHILE OPENING THE PACKAGE AND REMOVING THE INTRAOCULAR LENS (IOL), THE IOL WAS BENT. THERE WAS NO PATIENT CONTACT. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533585 ↗
• MalfunctionSep 17, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS (IOL) HAD A MISSING HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492287 ↗
• MalfunctionJul 6, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WOULD NOT UNFOLD AFTER BEING IMPLANTED INTO PATIENT'S OPERATIVE EYE. SURGERY WAS EXTENDED BY 10 MINUTES, SUTURES WERE NEEDED TO CLOSE THE WOUND. THE LENS WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A LENS OF DIFFERENT MODEL BUT SAME DIOPTER. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125115 ↗
• MalfunctionMar 15, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC LOOKED DEFECTIVE AND THE PLUNGER DID NOT WORK PROPERLY, SO THE LENS COULD NOT BE USED. A NEW LENS WAS USED WITH NO ISSUE AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490349 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A CATARACT SURGERY, THE HAPTIC OF INTRAOCULAR LENS BROKE. ISSUE HAPPENED WITHOUT PATIENT CONTACT. NO OTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283692 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED, DEFECTIVE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11141814 ↗
• InjuryNov 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED FROM THE PATIENT'S RIGHT EYE IN THE SAME PROCEDURE AS IT WAS NOT STABLE. A VITRECTOMY WAS REQUIRED AND THE INCISION WAS ENLARGED. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON IOL AS THE REPLACEMENT LENS. THERE WAS NO PATIENT INJURY POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10872313 ↗
• InjuryMar 25, 2020Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF AN INTRAOCULAR LENS (MODEL PCB00 17.0 DIOPTER) WAS AMPUTATED DURING INSERTION INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS CUT IN TWO PIECES AND WAS REMOVED. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9879415 ↗
• MalfunctionMar 12, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPROPERLY LOADED AND HAD PLUNGER ROD ISSUE WITH PATIENT CONTACT. ADDITIONAL INFORMATION STATES THE LENS WAS PARTIALLY INSERTED, HAPTIC WENT THROUGH THE CARTRIDGE SO THE DEPLOYMENT WAS NOT DONE. THERE WAS NO REMOVAL DONE AS THE LENS WENT OUT WITH THE INJECTOR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS. THERE WERE NO INCISION ENLARGEMENT, SUTURES, VITRECTOMY OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT IS DOING WELL POST-OP, NO SIDE EFFECTS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822287 ↗
• InjuryFeb 14, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE CARTRIDGE TIP STUCK IN THE EYE AS THE INTRAOCULAR LENS (IOL) WAS DISPENSED AND THE DOCTOR DETERMINED THE PLACEMENT WAS UNACCEPTABLE. THE IOL WAS REMOVED AND REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT MODEL LENS, ZCB00 17.0 DIOPTER IOL. SUTURES WERE USED TO SEAL THE EYE. THE LENS IS NOT AVAILABLE TO BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9714204 ↗
• InjuryFeb 12, 2020Break; Break

  DURING IMPLANTATION OF PCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE ACCOUNT REPORTED THE TRAILING HAPTIC WAS AMPUTATED (DETACHED). THE DOCTOR WAS ABLE TO EXCHANGE THE IOL WITHOUT INCIDENT AND KEPT THE BAG INTACT. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE INCISION WAS ENLARGED. THERE WAS NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), THERE WAS NO VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS NO NEGATIVE OUTCOME. THE SAME PROCEDURE WAS COMPLETED USING A ZCB00 17.0 DIOPTER IOL. REPORTED LENS DAMAGE WAS CAPTURED IN (B)(6) 2020 VMSR REPORTING. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9702525 ↗
• InjuryFeb 11, 2020Break; Break

  DURING IMPLANTATION OF PCB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE, ACCOUNT REPORTED THE TRAILING HAPTIC WAS AMPUTATED (DETACHED). THE DOCTOR WAS ABLE TO EXCHANGE THE IOL WITHOUT INCIDENT AND KEPT THE BAG INTACT. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS NO NEGATIVE OUTCOME. IT WAS REPORTED THAT A 10-0 NYLON SUTURE WAS USED AND THE SAME PROCEDURE WAS COMPLETED USING A ZCB00 17.0 DIOPTER IOL AS THE REPLACEMENT LENS. REPORTED LENS DAMAGE WAS CAPTURED IN JANUARY 2020 VMSR REPORTING. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9697301 ↗
• InjurySep 10, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A MODEL PCB00 INTRAOCULAR LENS, THE HAPTIC WAS NOTICED MISSING IN THE EYE. THE LENS WAS REMOVED AND REPLACED IT WITH A NEW LENS. AS PER FOLLOW-UP, AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE DAMAGED LENS IS NOTED TO HAVE BEEN DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8978587 ↗
• MalfunctionSep 6, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT SURGEON TRIED TO TWIST OUT THE PRELOADED INTRAOCULAR LENS, HOWEVER THE LENS DID NOT FULLY COME OUT. REPORTEDLY THERE WAS PATIENT CONTACT WITH NO HARM TO THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. THIS WAS OBSERVED WHILE INSERTING INTO THE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972952 ↗
• MalfunctionMay 22, 2019Contamination; Contamination

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, THE SURGEON OBSERVED A WHITE SUBSTANCE ENTERING THE ANTERIOR CHAMBER. REPORTEDLY, THE SUBSTANCE WAS EASILY ASPIRATED AND CLEARED. THE IOL WAS IMPLANTED WITHOUT ANY OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634827 ↗
• MalfunctionMay 8, 2019Material Deformation; Material Deformation

  A REPORT WAS RECEIVED THAT THERE WAS AN ISSUE WITH A MODEL PCB00 INTRAOCULAR LENS (IOL). THE BEZEL PLASTIC TIP HAD A PROTRUDING EDGE. THE DOCTOR OBSERVED THE PROBLEM WHEN WAS PREPARING TO IMPLANT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8591903 ↗
• MalfunctionDec 11, 2018Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE SURGEON BEGAN TO SCREW THE PLUNGER OF THE PRELOADED DELIVERY SYSTEM (MODEL PCB00), BUT THE LENS DID NOT COME OUT OF THE CARTRIDGE. REPORTEDLY, THERE WAS PATIENT CONTACT WITH BOTH THE CARTRIDGE TIP AND THE LENS. ANOTHER LENS WAS USED INSTEAD. THERE WAS NO PATIENT INJURY AND THERE WAS NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151154 ↗
• MalfunctionNov 27, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PCB00 +17.0 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) DID NOT COME OUT OF THE INSERTER AFTER THE SECOND PUSH OF THE PLUNGER. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE TIP AND THE LENS. ANOTHER PCB00 LENS WAS IMPLANTED. IT WAS ALSO NOTED THAT THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105616 ↗
• MalfunctionOct 24, 2018Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT WAS REPORTED THAT CARTRIDGE TIP OF PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED SPLIT. THE LENS GOT JAMMED, BUT STILL ABLE TO USE THE SAME LENS. THE REPORTED ISSUE OCCURRED DURING HANDLING, BUT PRIOR TO INSERTION INTO THE EYE. THERE WAS NO PATIENT IMPACT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7998515 ↗
• MalfunctionOct 3, 2018Break; Failure to Eject; Separation Problem; Break; Failure to Eject; Separation Problem

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE, THE INTRAOCULAR LENS (IOL) DID NOT COME OUT OF THE CARTRIDGE. REPORTEDLY, AFTER THE ISSUE WAS NOTICED AFTER THE SECOND PUSH OF THE PLUNGER. THE IOL DID NOT TOUCH THE PATIENT'S EYE. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY WITH NO PATIENT INJURY OR WOUND ENLARGEMENT. THE LENS WAS RETURNED AT THE MANUFACTURING SITE AND IT WAS NOTICED TO BE DAMAGED AND WITH ONE HAPTIC DETACHED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931798 ↗
• MalfunctionSep 11, 2018Material Separation; Difficult to Advance; Physical Resistance/Sticking; Material Separation; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT AS THE INTRAOCULAR LENS (IOL) WAS BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE, THE TRAILING HAPTIC GOT STUCK IN THE INJECTOR. REPORTEDLY, THE SURGEON TRIED TO RELEASE THE HAPTIC, BUT IT BROKE OFF AND IT APPEARED TO BE STILL IN THE INJECTOR. THE LENS HAD TO BE REMOVED FROM THE EYE AND ANOTHER LENS WAS IMPLANTED. THERE WAS NO ANTERIOR VITRECTOMY OR SUTURE REQUIRED. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE WHILE THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7863807 ↗
• MalfunctionSep 5, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT FIBER OR FOREIGN MATERIAL WAS OBSERVED ON PCB00 INTRAOCULAR LENS (IOL) DURING HANDLING, BUT PRIOR TO INSERTION. MOREOVER, THERE WAS NO PATIENT CONTACT. PRODUCT IS BEING RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7847411 ↗