TECNIS IOL PCB00 (REF PCB0000115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474558090), received between Oct 29, 2017 and Jan 30, 2024 — classified as 1 injury, 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Break; Break

  IT WAS INITIALLY REPORTED THAT THE LENS WAS DAMAGED AND COULD NOT BE USED. THROUGH FOLLOW-UP WE LEARNED THAT ONE HAPTIC WAS BENT ON THE PRELOADED INTRAOCULAR LENS (IOL). THE ISSUE HAPPENED DURING PREPARATION AND THE IOL WAS NOT USED IN THE PROCEDURE. ACCOUNT PROVIDED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE IOL WAS REPLACED WITH A NEW LENS OF THE SAME MODEL AND DIOPTER. EVERYTHING WAS FINE. THE ORIGINAL DEVICE HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608924 ↗
• MalfunctionMay 25, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS ( IOL) WOULD NOT BE DELIVERED CORRECTLY; THEREFORE, THE IOL HAD TO BE REMOVED DURING THE SAME PROCEDURE. THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007982 ↗
• MalfunctionSep 16, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE HAPTIC SLIPPED OUT SWIFTLY, THE LENS WAS NOT IN THE CAPSULE BAG. THE LENS WAS ON THE PATIENTS EYE, HOWEVER, NO FURTHER DETAILS ABOUT THE SURGERY AND PATIENTS OUTCOME WERE AVAILABLE. EVENT DATE WAS (B)(6) 2021. LENS IS AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484933 ↗
• InjuryMar 1, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED IOL WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DIMENSION ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 11396768 ↗
• MalfunctionJan 9, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF LENS WHEN ATTEMPTING TO ADVANCE THE LENS USING A PRELOADED DEVICE. HOWEVER, THE CUSTOMER CONFIRMED THAT HAPTIC WAS NOT DETACHED. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11143983 ↗
• MalfunctionMar 5, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT WHILE INSERTING A PCB00 PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT (OS) EYE, THE LEAD HAPTIC WAS NOT FOLDED AND LENS STUCK IN THE CARTRIDGE. THE LENS WAS PARTIALLY DELIVERED. THERE WAS NO SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. THE REPLACEMENT LENS USED IS THE SAME MODEL AND DIOPTER. THE CUSTOMER INDICATED THAT THE LENS IS NOT BEING RETURNED, AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795652 ↗
• MalfunctionJul 25, 2019Failure to Advance; Failure to Eject; Failure to Advance; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE, WAS STUCK IN THE CARTRIDGE, AND WOULD NOT ADVANCE. THE LENS WAS PARTIALLY INSERTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827508 ↗
• MalfunctionNov 27, 2018Mechanical Problem; Deformation Due to Compressive Stress; Mechanical Problem; Deformation Due to Compressive Stress

  IT WAS INITIALLY REPORTED THAT PRELOADED INTRAOCULAR LENS FAILED. THIS WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE TIP OF THE DEVICE WAS DEFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8105179 ↗
• MalfunctionFeb 20, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT WHILE INSERTING THE MONOFOCAL INTRAOCULAR LENS (MODEL PCB00 +11.5 DIOPTER) INTO THE EYE, THE HAPTIC WOULD NOT UNFOLD. THE LENS WAS REMOVED. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7284598 ↗
• MalfunctionJan 8, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS OBSERVED TORN WHILE INSERTING INTO THE EYE WHICH WAS REMOVED IN THE SAME SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174033 ↗
• MalfunctionOct 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE DOCTOR WAS REMOVING THE CARTRIDGE FROM THE EYE AND NOTICED A BLACK FLECK AT THE END/TIP OF IT. THERE WAS PATIENT CONTACT. NO COMPLICATIONS, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6986226 ↗