TECNIS IOL ZCB00 (REF ZCB0000055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474534629), received between Jan 31, 2017 and Jan 8, 2021 — classified as 4 injuries.

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.

• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE BECAUSE THE SURGEON NOTICED THERE IS NO CAPSULAR SUPPORT DURING POST OPERATIVE EXAM. VITRECTOMY ALONG WITH SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE IS NO CONFIRMATION THAT THE PATIENT HAS LOST MORE THAN 2 LINES OF VISUAL ACUITY, BUT VISION LINE IS NOTED 20/40. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions; Vitreous Loss

  MAUDE report 11142779 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) WHEN THE CAPSULAR BAG BROKE. THE LENS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER LENS, MODEL AR40E, 6.0 DIOPTER. THE INCISION WAS ENLARGED, AND VITRECTOMY WAS PERFORMED. PATIENT OUTCOME WAS REPORTED AS FINE, BUT PATIENT WAS UNHAPPY THAT THE CAPSULAR BAG WAS TORN. FURTHER INFORMATION STATED THAT THE PATIENT HAD BEEN POKED IN THE EYE WHICH CAUSED A TRAUMATIC INJURY PRIOR TO THE PROCEDURE/IMPLANT. IN EVALUATION OF THIS, IT WAS NOTED CATARACTS FORMING. THE EYE WAS WEAKENED BY THIS INJURY, AND WHEN IMPLANTING THE NEW LENS, THE BAG BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 10434635 ↗
• InjuryApr 13, 2019Break; Break

  IT WAS REPORTED THAT THERE WAS A LENS LOADING ISSUE WITH A NEW TECHNICIAN. THE ZCB00 5.5 DIOPTER LENS WAS INSERTED AND A SEVERED HAPTIC WAS OBSERVED. THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT (OD) EYE REQUIRING INCISION ENLARGEMENT, AND REPLACED WITH A BACK UP LENS. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8512003 ↗
• InjuryJan 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT HAD REPORTED THAT HIS VISION IN HIS RIGHT EYE HAD DETERIORATED APPROXIMATELY 3 TO 4 MONTHS AGO. HIS SYMPTOMS INCLUDE BLURRY VISION AND HE IS UNABLE TO DRIVE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6291632 ↗