TECNIS IOL PCB00 (REF PCB0000280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474558427), received between Nov 16, 2016 and Feb 1, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE LENS COULD NOT BE IMPLANTED BECAUSE THE PLUNGER BROKE THE LENS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279288 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS TWISTED. IT WAS INDICATED THAT THE ISSUE WAS IDENTIFIED DURING HANDLING / PRIOR TO THE INSERTION. IT IS UNKNOWN IF THERE WAS A PATIENT CONTACT. IT WAS NOTED THAT THE PATIENT FULLY RECOVERED. IT WAS NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007218 ↗
• MalfunctionNov 25, 2020Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A CATARACT SURGERY THE SURGEON HAD A PROBLEM WITH AN INTRAOCULAR LENS, MODEL PCB00, WHICH THE INJECTOR TIP DAMAGED THE OPTIC OF THE LENS. THE LENS WAS LEFT IN THE PATIENTS EYE. AFTER A FOLLOW-UP WE LEARNT THAT PATIENT WAS FINE AND VERY HAPPY ABOUT VISION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10902063 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT THE ANTERIOR SURFACE OF THE PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED DAMAGED DURING THE POST-OPERATIVE EXAMINATION. REPORTEDLY, THE LENS REMAINS IMPLANTED AND THERE ARE NO PLANS TO EXPLANT. THE PATIENT OUTCOME WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381218 ↗
• MalfunctionOct 28, 2018Break; Break

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WHEN REMOVED FROM PACKAGING HAD BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8011613 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG TORE AFTER A PCB00 28.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OD). THEREFORE, THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7892153 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR HAD TO CHANGE THE INTRAOCULAR LENS (IOL) DUE TO A BROKEN CAPSULE. THROUGH FOLLOW UP, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THE IOL WAS FULLY INSERTED AND THAT THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY AND NO SUTURES. A VITRECTOMY WAS PERFORMED AND THE PATIENT IS DOING IS WELL POST-PROCEDURE. A 3-PIECE LENS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7517402 ↗
• MalfunctionJun 29, 2017Break; Split; Break; Split

  IT WAS REPORTED THAT ONCE THE INTRAOCULAR LENS (IOL) WENT OUT, THE CARTRIDGE SPLIT. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY. DURING FOLLOW UP, IT WAS STATED THAT THE CARTRIDGE TIP WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6679498 ↗
• MalfunctionNov 16, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INJECTOR SLIDES NEXT TO THE INTRAOCULAR LENS (IOL) CAUSING DEBRIS ON THE IOL (TWICE). THERE WAS NO PATIENT CONTACT. THE LENS WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. THIS REPORT CAPTURES 2 OF 2 EVENTS. A SEPARATE MDR WILL BE FILED FOR THE FIRST EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6108183 ↗
• MalfunctionNov 16, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INJECTOR SLIDES NEXT TO THE INTRAOCULAR LENS (IOL) CAUSING DEBRIS ON THE IOL (TWICE). THERE WAS NO PATIENT CONTACT. THE LENS WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. THIS REPORT CAPTURES 1 OF 2 EVENTS. A SEPARATE MDR WILL BE FILED FOR THE SECOND EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6108177 ↗