TECNIS IOL ZCB00 (REF ZCB0000275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474531864), received between Mar 10, 2017 and Aug 11, 2022 — classified as 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER ZCB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO PATIENT'S EYE, DOCTOR NOTICED LENS HAD 3 DOTS AT THE HAPTIC OPTIC JUNCTION. IOL REMAINS IMPLANTED. VISION POST-OPERATIVE IS 6/6 1 DAY POST OP. NO IMPACT ON THE PATIENT'S VISION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214597 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT OF A MODEL ZCB00 27.5 DIOPTER INTRAOCULAR LENS (IOL), PATIENT EXPERIENCED A REFRACTIVE SURPRISE IN THE RIGHT EYE (OD). THE PATIENT IS STATUS POST (S/P) LASIK, S/P REFRACTIVE KERATOTOMY (RK), S/P ARCUATE KERATOTOMY (AK) YEARS AGO. GOAL TARGET WAS -2.00 DIOPTER; PATIENT ENDED UP WITH A -5.00D SER. PRE-OP REFRACTION WAS +0.25+0.50X153 VISUAL ACUITY (VA) 20/30, MEDIUM GLARE TO 20/50. POST-OP REFRACTION 5.25+0.50X160 (20/30-1). VA POST-OPERATIVE 20/50. DURING POST-EXAMINATION, THE PATIENT COMPLAINS OF BEING VERY NEARSIGHTED IN OD, LOSS OF DEPTH OF PERCEPTION, REFRACTIVE SURPRISE, AND BLURRY VISION. THE SURGEON PLANS TO EXPLANT THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8774013 ↗
• InjuryApr 23, 2019Adverse 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 PATIENTS LEFT EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE IOL WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8541875 ↗
• MalfunctionJan 11, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN ZCB00 INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE ON (B)(6) 2018, AND REMOVED DURING THE SAME PROCEDURE DUE TO A SCRATCH ON THE LENS OBSERVED BY THE SURGEON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP LENS. THERE WERE NO INJURIES AND NO ADDITIONAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241293 ↗
• MalfunctionNov 21, 2018Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT A MODEL ZCB00 27.5D (DIOPTER) TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED CRACKED AND TORN ON EACH SIDE RIGHT BEFORE THE LENS WAS INSERTED INTO THE EYE. REPORTEDLY, THE CUSTOMER USED A NON-JOHNSON & JOHNSON INJECTION SYSTEM DURING IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH THE SAME SIZE AND MODEL LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097429 ↗
• MalfunctionMar 10, 2017Sticking; Sticking

  IT WAS REPORTED THAT THE HAPTIC STUCK TO THE OPTIC AND THE HAPTICS STUCK TO EACH OTHER. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6397624 ↗