TECNIS IOL ZCB00 (REF ZCB0000095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474531505), received between Feb 23, 2017 and Dec 4, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Scratched Material; Scratched Material

  A SCRATCH IN NON PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER IT'S IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. LENS WAS REMOVED DURING SAME PROCEDURE HOWEVER IT IS UNKNOWN IF ANOTHER IOL WAS IMPLANTED. DURING THE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, MEDICAL ATTENTION, PROCEDURAL DELAYS, SUTURES, OR VITRECTOMY. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED. THERE ARE NO DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT THEY WERE ABLE TO PRIOR TO THE SURGERY. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840654 ↗
• MalfunctionOct 4, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS IT WOULD NOT UNFOLD. LENS WAS DISCARDED AT THE SITE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572313 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULE BAG TORE, THEREFORE, THE SURGEON HAD TO CHOOSE A DIFFERENT INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear

  MAUDE report 9955889 ↗
• InjuryMar 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF LENS MODEL, ZCB00 MONOFOCAL IOL (INTRAOCULAR LENS) THERE WAS A MECHANICAL COMPLICATIONS. THE LENS WAS EXPLANTED AND REPLACED WITH +23.5 DIOPTER ZCB00 LENS. NO COMPLICATIONS WERE REPORTED AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446510 ↗
• MalfunctionOct 31, 2018Scratched Material; Scratched Material

  IT WAS REPORTED WHEN REMOVING A ZCB00 9.5 DIOPTER INTRAOCULAR LENS (IOL) FROM PACKAGING CUSTOMER ACCOUNT REPORTED A SCRATCH WAS NOTICED ON THE IOL UPON OPENING. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO PATIENT CONTACT, CONFIRMED OUT OF BOX FAILURE AND PRODUCT WAS NOT HANDLED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACKUP LENS OF THE SAME MODEL AND DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8027048 ↗
• InjuryAug 29, 2018Break; Break

  IT WAS REPORTED THAT ZCB00 MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS OBSERVED BROKEN AFTER IT INSERTED INTO PATIENT'S EYE. CONSEQUENTLY, INCISION ENLARGEMENT WAS PERFORMED TO REMOVE IOL AND REPLACED WITH THE SAME MODEL. THERE WERE NO SUTURE AND NO PATIENT INJURY HOWEVER. PRODUCT IS EXPECTED TO BE RETURN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7830236 ↗
• MalfunctionOct 12, 2017Material Discolored; Material Discolored

  IT WAS REPORTED THAT WHEN A ZCB00 9.5 DIOPTER INTRAOCULAR LENS (IOL) HOLDER WAS OPENED TO SET THE LENS INTO THE CARTRIDGE FOR IMPLANTATION, THE SURGEON NOTICED A GRAY ZONE, PERHAPS CLOUDY, EITHER ON OR INSIDE THE CENTER OF THE LENS. REPORTEDLY, THE LENS WAS NOT IMPLANTED AND THE PATIENT WAS NO AFFECTED. ANOTHER LENS WAS USED AND IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6946905 ↗
• InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCB00 INTRAOCULAR LENS (IOL) HAD TO BE EXPLANTED. THE REASON FOR EXPLANT WAS NOT PROVIDED. THE CUSTOMER INDICATED THEY USED A NON VALIDATED CARTRIDGE WITH THE LENS AND WERE INFORMED THAT THIS PRACTICE IS NOT RECOMMENDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6354962 ↗