TECNIS IOL ZCB00 (REF ZCB0000285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474531888), received between Mar 21, 2017 and Dec 4, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, SURGEON NEEDED TO DO ANTERIOR VITRECTOMY AND REQUIRED AC LENS INSTEAD. VITRECTOMY WAS PERFORMED. THERE WAS PATIENT CONTACT WITH REMOVAL AND REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 9409541 ↗
• MalfunctionJul 17, 2019Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT LENS MUNCHED IN THE PLASTIC CARTRIDGE AND DISPENSED SQUISHED. LENS WAS STUCK IN CARTRIDGE. REPORTEDLY LENS WAS REMOVED FROM THE EYE IN THE SAME SURGICAL PROCEDURE AND REPLACED WITH ANOTHER NEW LENS. SURGERY COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796892 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN INSERTING A INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE CAPSULE WAS UNABLE TO SUPPORT THE LENS. THE IOL WAS REMOVED DURING THE SAME PROCEDURE, AND AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY, AND NO ADDITIONAL INTERVENTION REQUIRED. ANOTHER LENS (DIFFERENT MODEL) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8698311 ↗
• InjuryMar 21, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT HAD A ZCB00 INTRAOCULAR LENS (IOL) EXPLANTED 6 DAYS POST IMPLANTATION. THE INITIAL LENS WAS A +28.5 DIOPTER AND WAS REPLACED WITH A LOWER DIOPTER IOL (25.0). THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. THE PATIENT¿S UNCORRECTED VISUAL ACUITY (UCVA) PRE-OP IN THE LEFT EYE (OS) WAS 20/50, POST-OP 20/200. STANDARD CATARACT POST-OPERATIVE DROP ROUTINE WAS NOTED. THE PATIENT¿S OUTCOME AFTER REPLACEMENT PROCEDURE WAS REPORTED AS EXCELLENT. POST OP VISUAL ACUITY IS 20/20.

  Patient problems: No Code Available

  MAUDE report 6423072 ↗