TECNIS IOL PCB00 (REF PCB0000180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05050474558229), received between Oct 7, 2016 and May 25, 2023 — classified as 16 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD NO HAPTIC. THE ISSUE WAS DISCOVERED DURING THE HANDLING OF THE LENS AND THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007549 ↗
• MalfunctionMar 29, 2023Break; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Break; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FAULTY. THROUGH FOLLOW UP WE LEARNED THAT THE IOL CAME OUT WITH AN UNUSUAL SHAPE AND DID NOT OPEN CORRECTLY. THE IOL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACK-UP LENS. NO COMPLICATIONS WERE REPORTED AND THERE WERE NO SIGNIFICANT DELAYS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640641 ↗
• MalfunctionMar 15, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH THE LENS. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS S/N (B)(4) HAD MISFIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550701 ↗
• MalfunctionOct 29, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE PLUNGER STUCK TO THE LENS. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. THROUGH FOLLOW UPS IT WAS CONFIRMED THAT THERE WAS AN ISSUE WITH THE PLUNGER ROD AND THAT THE LENS WAS DAMAGED DUE TO THIS ISSUE. NO ADDITIONAL INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12717044 ↗
• MalfunctionOct 24, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CUSTOMER REPORTED LENS DAMAGED AND STUCK IN CARTRIDGE WITH A MODEL PCB00 TECNIS ITEC PRELOADED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686768 ↗
• InjuryOct 19, 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 OPERATIVE EYE. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Eye Injury

  MAUDE report 12661790 ↗
• MalfunctionJul 30, 2021Crack; Difficult to Fold, Unfold or Collapse; Crack; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE AND ALSO THE INJECTOR CRACKED DURING INSERTION EVEN THOUGH THE TIME AND TECHNIC WAS ACCURATE. THERE WAS PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256115 ↗
• MalfunctionJul 9, 2021Break; Mechanical Problem; Mechanical Jam; Break; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO INJECT THE PRELOADED INTRAOCULAR LENS AS THE PLUNGER WAS ON TOP OF THE LENS INSTEAD OF BEHIND IT. THERE WAS DAMAGE TO THE LENS DUE TO THE ISSUE. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE TIP. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. A NEW LENS WAS OPENED UP FOR THE CASE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148033 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE RIGHT EYE OF A PATIENT, A DIVOT IN THE CENTER OF THE LENS WAS OBSERVED. THE IOL WAS REMOVED AND REPLACED AFTER CUTTING THE LENS IN TWO PIECES. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772634 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT (OS) EYE, BUT HAD TO BE REMOVED BECAUSE THE LENS WAS KINKED. THE PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER TECNIS ITEC, SERIAL NUMBER (SN) (B)(4). REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627112 ↗
• MalfunctionFeb 22, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  INITIALLY, THE CUSTOMER REPORTED THAT A TECNIS PRELOADED SYSTEM IS DEFECTIVE. IT WAS UNCLEAR IF THE LENS OR THE PRELOADED INSERTER WAS DEFECTIVE. THROUGH FOLLOW-UP, THE CUSTOMER CLARIFIED THAT THE INTRAOCULAR LENS (IOL) DID NOT UNFOLD AND REQUIRED REMOVAL FROM THE PATIENT'S EYE. THERE IS NO INJURY REPORTED AND NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED DURING THE INITIAL PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362983 ↗
• InjurySep 25, 2020Break; Crack; Failure to Fold; Break; Crack; Failure to Fold

  CUSTOMER REPORTED THAT THE LENS IMPLANT WAS INSERTED INTO THE CAPSULAR BAG AND IT WAS AT THIS POINT THAT IT WAS NOTED THAT THE TRAILING HAPTIC HAD TORN OFF IN THE INSERTER OR DURING MANUFACTURING. THE LENS IMPLANT WAS ROTATED ABOVE THE IRIS PLANE. A MICRO FORCEPS AND SCISSORS WERE USED TO NEAR BISECT THE IMPLANT AND IT WAS THEN REMOVED BY PULLING ON THE REMAINING HAPTIC. DURING THIS, THE IMPLANT FAILED TO BEND AT THE SMALL ATTACHMENT REMAINING FROM THE BISECTION AND CAUSED A SMALL SUB INCISIONAL HYPHEMIA. THE BACKUP IMPLANT WAS THEN INJECTED INTO THE CAPSULAR BAG AND BOTH HAPTICS WAS ROTATED INTO POSITION. THE PROCEDURE WAS COMPLETED WITH A BACKUP IOL. THE BACKUP IOL SERIAL NUMBER IS NOT AVAILABLE. THE CUSTOMER ALSO REPORTED THAT THE INCISION WAS ENLARGED. NO SUTURES WERE USED INSTEAD RESURE SEALANT WAS USED. THE CUSTOMER EXPLAINED THAT THEY CANNOT RETURN THE IOL AS IT BROKE OFF IN PIECES. THE CUSTOMER THE PATIENT'S POSTOP VISITS AS THE PATIENT HAD A FAIR AMOUNT OF INFERIOR CORNEAL EDEMA, BUT OTHERWISE HIS EYE LOOKED PRETTY TYPICAL FOR 1 DAY POSTOP AND HIS VISION IS EXCELLENT. PATIENT CONTINUES THE EYEDROPS AS DIRECTED. THE AMOUNT OF CORNEAL EDEMA CONTINUED BUT ALSO IMPROVED BY THE

  Patient problems: Corneal Edema; Hyphema

  MAUDE report 10584862 ↗
• InjurySep 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) STARTED TO FALL; CAPSULE BAG TORE, THEREFORE, A VITRECTOMY WAS PERFORMED. THE INCISION WAS ENLARGED. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT HAS RECOVERED. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 10498044 ↗
• InjuryApr 27, 2020Scratched Material; Scratched Material

  THE SURGEON INITIALLY REPORTED THAT HE NOTICED A PCB00 INTRAOCULAR LENS WAS DEEPLY SCRATCHED AT THE TIME OF SURGERY, AND THOUGHT THAT IT WOULD NOT NEGATIVELY IMPACT PATIENT'S VISION AS THE SCRATCH WAS NOT CENTRAL LOCATED. HE WAS NOT CERTAIN IF THIS WAS RELATED TO A MANUFACTURING RELATED ISSUE, OR HUMAN ERROR DURING THE LENS PREPARATION, LOADING OR DEPLOYMENT PROCESS. ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP REPORTED THAT THE PATIENT COMPLAINS OF HAVING SIGNIFICANT GLARE POST SURGERY. THE PATIENT IS SCHEDULED FOR AN IOL EXCHANGE ONCE COVID-19 QUARANTINE ENDS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10002470 ↗
• MalfunctionFeb 18, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CLEARLY VISIBLE GROVES OF MODERATE STRENGTH WERE OBSERVED ON THE OPTIC OF THE LENS DURING IMPLANTATION. NO EXPLANT IS PLANNED AND NO IMPACT ON PATIENTS VISION HAS BEEN REPORTED. ADDITIONAL INFORMATION STATES NO INTERVENTIONS ARE PLANNED, SO FAR OUTCOME SEEMS GOOD. NO REPORTS OF HALOS OR OTHER VISUAL ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719124 ↗
• InjuryOct 29, 2019Failure to Eject; Failure to Eject

  IT WAS INITIALLY REPORTED THAT LENS HAD PROBLEM OF DEPLOYMENT. CUSTOMER REPORTED THAT THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS GOT STUCK IN INJECTOR. THE LENS WAS REMOVED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS IN SAME SURGICAL PROCEDURE. REPORTEDLY INCISION WAS ENLARGED, AND SURGERY REMAINED THE SAME AS EXPECTED. THE PATIENT IS FINE AND VISUAL ACUITY IS 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9252834 ↗
• InjuryOct 16, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INSERTION OF A MODEL PCB00 INTRAOCULAR LENS, THE OPTIC WAS OBSERVED TO BE VERY HEAVILY SCRATCHED. SURGEON REMOVED THE LENS FROM THE EYE AND IMPLANTED ANOTHER LENS OF THE SAME DIOPTER WITH NO ISSUES. ADDITIONAL INFORMATION WAS PROVIDED, AND IT WAS LEARNED, THE WOUND HAD TO BE ENLARGED FOR THE SCRATCHED LENS TO CUT UP AND THEN REMOVED. THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION, AND PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9195382 ↗
• MalfunctionSep 12, 2019Failure to Eject; Failure to Eject

  WHILE INSERTING PCB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE CUSTOMER ACCOUNT REPORTED THE IOL GOT STUCK ON THE INJECTOR, IT DID NOT RELEASE FULLY FROM THE INJECTOR AS IT SHOULD HAVE. THE DOCTOR HAD TO USE HIS SECOND INSTRUMENT TO GET THE LENS OFF THE INJECTOR. THE IOL IS IN THE PATIENT¿S EYE AND DIDN'T CAUSE ANY HARM. IT WAS REPORTED THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND THE LENS IS NOT BEING RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT¿S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9007640 ↗
• InjuryAug 9, 2019Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE DOCTOR EXPERIENCED AN ISSUE WITH THE LOADER OF THE PRELOADED INTRAOCULAR LENS (IOL) CAUSING AN IRIS LACERATION AND RUPTURE. FURTHER A HEMATOMA WAS REPORTED IN THE ANTERIOR CHAMBER. MEDICAL INTERVENTION WITH DROPS WAS PRESCRIBED POST OP. PATIENT VISUAL ACUITY WAS 20/40 AND A SLOWER VISUAL RECOVERY WAS NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Laceration(s); Rupture

  MAUDE report 8877397 ↗
• MalfunctionJul 26, 2019Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) AFTER INSERTION, IT WAS NOTICED THAT THE TRAILING HAPTIC WAS BROKEN/TRAILING HAPTIC NOT FOLDED. THERE WAS NO MENTION OF ADVERSE EVENTS. THE PATIENT HAS RECOVERED. DOCTOR AND PATIENT IDENTIFIERS WERE PROVIDED. SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8831068 ↗
• InjuryJul 10, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO DISLOCATION OF THE IOL. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH ACTIVITY OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8774392 ↗
• MalfunctionApr 16, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS GOT CAUGHT UP AND COULD NOT COME OUT OF THE NOSE CONE. THERE WAS PATIENT CONTACT WITH THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED, NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516904 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT BILATERAL IMPLANTS IN 2017, AND IN (B)(6) 2019 WAS DIAGNOSED WITH CLOUDING SAC. A MODEL PCB00, 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE. THE PATIENT REPORTS THAT EVER SINCE THE LENSES WERE IMPLANTED, HE HAS EXPERIENCED VISUAL ISSUES, HALOS, GLARE, AND STARBURSTS. THE SAME SURGEON IMPLANTED BOTH RIGHT AND LEFT LENSES TWO YEARS AGO. THE PATIENT CONTINUED WITH HIS FOLLOW-UPS, AND HE HAS BEEN COMPLAINING OF HIS VISUAL ISSUES BUT CLAIMS THAT THE DOCTOR DID NOT DO ANYTHING ABOUT THEM. HE STATED THAT THE LAST TIME HE WENT BACK TO HIS IMPLANTING DOCTOR WAS AROUND (B)(6) 2019, THE PATIENT FOUND OUT THAT THE DOCTOR HAS MOVED TO ANOTHER PRACTICE. IN (B)(6) 2019, THE PATIENT THEN WENT TO HIS CURRENT DOCTOR AND WAS DIAGNOSED WITH CLOUDING OF THE SAC. THE DOCTOR ALSO MENTIONED TO THE PATIENT THAT HE HAS GLAUCOMA AND HAD MICRO-BYPASS GLAUCOMA STENTS PUT IN BOTH OF HIS EYES. DESPITE THE STENTS, ALTHOUGH HIS VISION IS OK, THE VISUAL ISSUES STILL ANNOY HIM ESPECIALLY DURING NIGHT DRIVING. THE PATIENT ALSO INITIALLY REPORTED THAT HE UNDERWENT A PROCEDURE TWO WEEKS LATER, A SURGERY WITH A WIDENED INCISION, BUT SYMPTOMS HAVE NOT IMP

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8454687 ↗
• MalfunctionMar 18, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS WAS MISSING THE TRAILING HAPTIC THIS WAS OBSERVED WHILE INSERTING THE LENS INTO THE EYE. REPORTEDLY CUSTOMER STATED THAT PLUNGER DIDN'T FEEL DIFFERENT WHEN INSERTING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427494 ↗
• InjuryMar 16, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 18.0 DIOPTER MONOFOCAL LENS GOT STUCK IN THE CARTRIDGE WHILE ATTEMPTING TO INSERT IT INTO THE LEFT EYE. THE LENS HAD PATIENT CONTACT AND THE INCISION WAS ENLARGED. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8426911 ↗