TECNIS IOL ZCB00 (REF ZCB0000290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474531895), received between Oct 28, 2017 and Jun 20, 2025 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED LENS HAD A TORN HAPTIC, PROMPTING THE DOCTOR TO REMOVE AND REPLACE IT WITH A BACKUP LENS DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION SUGGESTS THAT THERE WAS A LOADING ERROR, BUT NOT A USE ERROR. THERE WAS NO INJURY, AND NO FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302148 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHILE INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE CAPSULE BROKE. THE DOCTOR REMOVED THE LENS AND INSERTED A MODEL Z9002 LENS INTO THE SULCUS OF THE EYE WITHOUT HAVING TO DO A VITRECTOMY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO UNPLANNED SUTURE(S). PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS SO FAR FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11891863 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE PATIENT WAS SET FOR NEAR AND WAS UNHAPPY. IT WAS STATED THAT THE NEAR IS TOO CLOSE. OTHER VISUAL SYMPTOMS ARE DIFFICULTY READING, REFRACTIVE SURPRISE, MYOPIA. HENCE, THE DOCTOR REPLACED THE LENS WITH ANOTHER LENS OF THE SAME MODEL, BUT DIFFERENT POWER. AT EXPLANT AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE PATIENT IS HAPPY WITH THE RESULTS POST-EXCHANGE. THE SUSPECT PRODUCT WAS DISCARDED BY THE FACILITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10210511 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8427146 ↗
• MalfunctionNov 6, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A SMALL FILAMENT WAS NOTICED INSIDE THE PATIENT'S EYE AFTER IMPLANTATION OF THE ZCB00 +29.0 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS). REPORTEDLY, THE SURGEON SUCCESSFULLY REMOVED THE FILAMENT FROM THE EYE AND NO INJURY OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041428 ↗
• InjuryOct 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 29.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED USING A 1MTEC30 CARTRIDGE IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, ONE DAY AFTER SURGERY, THE DOCTOR DIAGNOSED THE PATIENT AS HAVING HYPOPYON, FIBRIN MEMBRANE, SNOWSTORM, WHICH BECAME WORSE THE SECOND DAY AFTER SURGERY AND EXTENDING INTO THE VITREAL CAVITY. THE DOCTOR ALSO THINKS THAT THE PATIENT HAS POSSIBLE ENDOPHTHALMITIS. IN ADDITION THE PATIENT HAD SIGNIFICANT ENDOTHELIAL FOLDS-EDEMA AND FIBRIN WHICH SOME WERE MORE SEVERE THAN OTHERS. REPORTEDLY, A VITRECTOMY WAS PERFORMED AND ANTIBIOTIC INJECTIONS WERE GIVEN TO THE PATIENT ON (B)(6) 2017. THE PATIENT ALSO RECEIVED TOPICAL ANTIBIOTICS, INTENSE STEROIDS, AND OMIDRIA. THE IOL REMAINS IMPLANTED, THERE IS NO PLAN TO EXPLANT. NO ADDITION INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE ZCB00 INTRAOCULAR LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE CARTRIDGE.

  Patient problems: Edema; Hypopyon; Vitrectomy

  MAUDE report 6985990 ↗