TECNIS IOL PCB00 (REF PCB0000285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474558434), received between Aug 7, 2017 and Jul 28, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 17414703 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT THE LEADING HAPTIC WAS DEFECTIVE ACCORDING TO SURGEON. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560708 ↗
• MalfunctionDec 10, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) MISFIRED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979743 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT AND VITRECTOMY WAS REQUIRED. THE DOCTOR USED A DIFFERENT LENS TO COMPLETE THE PROCEDURE. PATIENT OUTCOME WAS REPORTED AS: FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vitrectomy

  MAUDE report 10788937 ↗
• MalfunctionApr 30, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) SEEMED STUCK AT FIRST THEN RAPIDLY SLIPPED OUT OF THE CARTRIDGE NEARLY MISSING THE INSERTION INCISION IN THE PATIENT'S RIGHT EYE. THE LENS WAS ABLE TO BE INSERTED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014992 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PCB00 28.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. THE LENS IN NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9738984 ↗
• MalfunctionNov 11, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PCB00 28.5 DIOPTER LENS WAS NOTICED SCRATCHED AFTER BEING IMPLANTED. REPORTEDLY, THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8058584 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED BROKEN UPON INSERTION INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT, BUT THE SURGEON WAS ABLE TO RETRIEVE THE LENS BEFORE FULLY IMPLANTING IT. ANOTHER LENS WAS SUCCESSFULLY IMPLANTED AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED HEALING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032002 ↗
• MalfunctionApr 12, 2018Crack; Crack

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS CRACKED. REPORTEDLY, THE LENS AS FOUND CRACKED UPON OPENING THE PACKAGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7426438 ↗
• MalfunctionAug 7, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE SURGEON HAD TO TWIST THE INJECTOR SLIGHTLY IN ORDER FOR THE LENS TO RELEASE FROM THE CARTRIDGE. HOWEVER, IN THIS OCCASION THE LENS DID NOT DEPLOY FROM THE CARTRIDGE. THE LENS WAS INSIDE THE PATIENTS EYE BUT THEY COULD NOT DISCONNECT IT FROM THE CARTRIDGE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PLUNGER OF THE INJECTOR OVERRODE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772778 ↗