TECNIS IOL PCB00 (REF PCB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 05050474558328), received between Aug 23, 2016 and Jan 10, 2025 — classified as 25 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT AFTER OPENING A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) A CRACK WAS FOUND ON THE LENS. LENS WAS NOT IMPLANTED IN THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130691 ↗
• 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 17414734 ↗
• MalfunctionMay 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, A EXTRA MATERIAL OF UNKNOWN ORIGIN WAS OBSERVED IN THE PATIENT'S OPERATIVE EYE. THE MATERIAL WAS REMOVED DURING THE ASPIRATION STAGE. THE LENS REMAINS FULLY IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS ISSUE OCCURRED TWICE DURING THE SURGERY DAY. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER INCIDENT AND LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892140 ↗
• MalfunctionApr 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE SURGEON RELEASED THE PRELOADED INTRAOCULAR LENS (IOL) FROM THE INJECTOR FOR IMPLANTATION INTO THE PATIENT'S CAPSULAR BAG, THE IOL WAS TORN/SEVERED AND SPLIT INTO 3 PIECES. ALL 3 PIECES OF IOL WERE REMOVED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. AN IDENTICAL 1-PIECE LENS WAS INSERTED FOLLOWING THE REMOVAL. ACCOUNT INDICATED THAT THERE WAS A DELAY IN THE PROCEDURE. WE LEARNED THROUGH FOLLOW UP THAT SUTURES WERE NOT REQUIRED AND A VITRECTOMY WAS NOT CARRIED OUT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812158 ↗
• MalfunctionMar 22, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SHOT OUT OF LOADER FAST. IT IS NOTED "OPENED/DAMAGE DURING SURGERY". THERE WAS NO PATIENT CONTACT, HOWEVER IT IS NOTED THAT SURGEON'S OBSERVATIONS WAS THAT IT IS CONTAMINATED. "DAMAGED LENS" IS ALSO NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595260 ↗
• MalfunctionFeb 27, 2023Break; Break

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) UNFOLDED A CRACK WAS FOUND ON THE NASAL SIDE OF THE IOL. SURGEON DECIDED TO LEAVE THE LENS IN SITU. THE PATIENT HAS AGE-RELATED MACULAR DEGENERATION (AMD) AND HAS POOR PERIPHERAL VISION. PER THE SURGEON THIS ANOMALY WOULD NOT AFFECT THE PATIENT'S OVERALL VISION. THROUGH FOLLOW UP WE LEARNED THAT THERE WAS NO FEEDBACK ON THE PATIENT'S CONDITION AND THAT THE PRELOADED DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449381 ↗
• MalfunctionDec 13, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) MISFIRED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS PATIENT CONTACT AND THE PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965890 ↗
• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS RECEIVED BROKEN. THROUGH FOLLOW UP WE LEARNED THAT THE IOL HAD A BROKEN BACK HAPTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089749 ↗
• MalfunctionMay 25, 2022Inaccurate Delivery; Mechanical Jam; Scratched Material; Inaccurate Delivery; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED ON THE INJECTOR AND DID NOT COMPLETELY EXIT THE INJECTOR. THE CARTRIDGE TIP CONTACTED THE EYE. PATIENT IS IN GOOD HEALTH, BUT CUSTOMER HAD TO REPLACE IT WITH ANOTHER IOL. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO PATIENT INJURY REPORTED. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493425 ↗
• MalfunctionApr 28, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AFTER INJECTING THE VISCOELASTIC, PUSHING THE PLUNGER, THERE WAS A LOT OF RESISTANCE IN THE PROCESS. THE CARTRIDGE SECTION WAS OPENED AND THE LENS WAS FOUND TO BE FAULTY. ISSUE HAPPENED DURING PREPARATION, NO PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14233904 ↗
• MalfunctionApr 19, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS SCRATCH WAS SEEN ON THE LENS AFTER INSERTION. THERE WAS A DELAY OF 5 MINUTES AND THE PATIENT HAS FULLY RECOVERED. DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14151454 ↗
• MalfunctionMar 14, 2022Break; Break

  IT HAS BEEN REPORTED DEFECTIVE (THE PLUNGER HAS BROKEN THE HAPTIC). NO CONTACT WITH PATIENT'S EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758267 ↗
• MalfunctionDec 19, 2021Break; Break

  IT HAS BEEN REPORTED THAT THE LENSES WERE DEFECTIVE. NO INFORMATION REGARDING PATIENT INVOLVEMENT OR PATIENT INJURY HAVE BEEN PROVIDED, NOR ABOUT MATERIAL AVAILABILITY. NO MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR THE FIRST LENS. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER REPORTED LENSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040270 ↗
• MalfunctionDec 8, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS LOADED, THE SURGEON OBSERVED THAT ONE OF THE HAPTICS WAS BROKEN. NO PATIENT INJURY WAS REPORTED. THROUGH FOLLOW UPS IT WAS CONFIRMED THAT THE TRAILING HAPTIC WAS CAUGHT IN THE CARTRIDGE AND BROKE. THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED / CUT OUT FROM THE EYE AND ANOTHER LENS WAS INSERTED INSTEAD. ACCOUNT PROVIDED THAT THE PROCEDURE WAS DELAYED BY 20 MINUTES AND NO SECONDARY PROCEDURE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965414 ↗
• MalfunctionDec 8, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE LENS BECAME DEFECTIVE AS IT GOT STUCK INSIDE THE CARTRIDGE. IT WAS INDICATED THAT THE LENS IS STILL STUCK INSIDE THE CARTRIDGE AND THEY CANNOT SEE THE DAMAGE DONE TO THE LENS. NO CONTACT WITH PATIENT'S EYE AS THE ISSUE WAS NOTICED DURING HANDLING/PRIOR TO INSERTION, NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964968 ↗
• MalfunctionNov 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE SECOND HAPTIC WAS BROKEN DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT'S LEFT EYE. THE HAPTIC EXITED SEPARATELY OUT OF CARTRIDGE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND A NEW LENS WAS INSERTED. THE ISSUE DID NOT SIGNIFICANTLY EFFECTED THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE PATIENT FULLY RECOVERED AND NO ISSUES WERE REPORTED. VISION PRE-OPERATIVE: 0,4 WITH CORRECTION. VISION POST-OPERATIVE: 0,4 WITH CORRECTION 1-DAY POST-OP. IT WAS NOTED THAT THERE WAS A 30-MINUTES DELAY IN THE PROCEDURE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759719 ↗
• MalfunctionNov 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FAULTY AS IT HAD ONLY ONE HAPTIC. THE LENS WAS REMOVED FROM THE EYE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739503 ↗
• MalfunctionSep 3, 2021Inaccurate Delivery; Inaccurate Delivery

  CUSTOMER REPORTED HAVING PROBLEMS DURING THE INJECTION OF THE TECNIS ITEC PCB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) IN THE PATIENT¿S EYE, BECAUSE THE HANDLE OF THE IOL CAME TOTALLY OUT OF THE CORRECT POSITION WHEN LEAVING THE PRELOADED CARTRIDGE. PHYSICIAN MOUNTED THE IOL CORRECTLY IN ANOTHER NEW CARTRIDGE AND IMPLANTED IT IN THE PATIENT¿S EYE NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426033 ↗
• MalfunctionAug 4, 2021Break; Break

  IT HAS BEEN REPORTED THAT DURING THE LOADING OF THE LENS IN THE PRELOADED SYSTEM, THE HAPTICS HAVE BROKEN. NO CONTACT WITH THE PATIENT'S EYE AND NO PATIENT INVOLVEMENT. MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276116 ↗
• MalfunctionJul 15, 2021Break; Mechanical Jam; Scratched Material; Break; Mechanical Jam; Scratched Material

  IT HAS BEEN REPORTED ISSUES WITH A PCB00. DEFECTIVE LENS, CUSTOMER MENTIONED WHEN THE LENS REACHED THE EDGE OF THE CARTRIDGE IT DID NOT COME OUT, IT WAS STUCK. ALSO, LENS WAS SCRATCHED. NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177764 ↗
• MalfunctionJul 15, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  CUSTOMER REPORTED THAT FOR ONE PRELOADED LENS (MODEL PCB00), THE TIP OF THE CARTRIDGE WAS BROKEN AND FOR ANOTHER PCB00 THE LENS WAS STUCK IN THE INSERTER. THEY COULD NOT LINK THE ISSUE TO A SPECIFIC SERIAL NUMBER. THRU FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE DEFECT WAS DETECTED DURING THE PREPARATION PHASE EXCEPT FOR ONE CASE WHERE THE TIP OF THE INJECTOR WAS IN THE ANTERIOR CHAMBER; HOWEVER, THE SURGEON WITHDREW THE TIP OUT OF THE ANTERIOR CHAMBER AND USED A NEW PCB00 LENS TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER INDICATED THAT THESE TWO CASES ARE FROM WITHIN THE PAST YEAR. THEREFORE, ADDITIONAL INFORMATION IS NO LONGER AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 CAPTURING SERIAL# (B)(4). THE OTHER SERIAL# (B)(4) WILL BE CAPTURED IN A SEPARATE MDR REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177414 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC BROKE WHILE ADVANCING IN THE CARTRIDGE. THE LENS WAS PARTIALLY INSERTED. THERE WAS PATIENT CONTACT, BUT NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED AND THE LENS WAS DISCARDED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171347 ↗
• MalfunctionJul 15, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS INITIALLY REPORTED THAT THE SURGEON HAD TO CUT OUT THE INTRAOCULAR IOL AS THERE WAS A MARK ON THE OPTIC, IT WAS DEFECTIVE. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS PROVIDED EXPLAINING THAT THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S OPERATIVE EYE. THE IOL WAS THEN REMOVED AND REPLACED WITH THE SAME TYPE OF LENS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO KNOWN INJURY TO THE PATIENT AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED, HOWEVER, UNKNOWN IF SUTURE WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171198 ↗
• InjuryJul 7, 2021Difficult to Advance; Difficult to Advance

  DURING THE IMPLANT OF THE LENS, RESPECTING THE TIMES INDICATED BY THE MANUFACTURER IN EACH ONE OF THE STEPS, THE LENS COULD NOT COME OUT FROM THE INJECTOR, EVEN WITH THE PROGRESSION OF THE PISTON TILL THE END OF THE ROUTE. AIMING AT NOT LEAVING THE PATIENT APHAKIC, ANOTHER LENS WITH SIMILAR DIOPTER WAS FOUND AND IMPLANTED BY INCREASING THE INCISION AND SUTURING. LENS INSERTED AND REMOVED AT THE SAME PROCEDURE. PATIENT COMPLETELY RECOVERED. PRE OP VISION: HANDS MOVEMENT; POST OP VISION: STILL UNDER POST OP EVALUATION. PROCEDURE DELAYED FOR 15 MINUTES. MEDICATION PRESCRIBED (ANTIBIOTIC AND CORTICOID EYE DROPS). LEFT EYE WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132072 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT AFTER THE LENS WAS IMPLANTED INTO THE EYE, IT WAS FOUND THAT THE LENS OPTIC WAS DAMAGED. THE LENS WAS REMOVED AND REPLACED AND INCISION WAS ENLARGED. VISION PRE-OPERATIVE: 0.6. VISION POST-OPERATIVE: 0.02. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038176 ↗