TECNIS IOL ZCB00 (REF ZCB0000135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474531581), received between Oct 6, 2016 and Dec 30, 2019 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON FOUND A DAMAGED AREA IN THE MIDDLE OF THE OPTIC FOLLOWING IMPLANTATION. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THROUGH FOLLOW-UP WE LEARNED THAT THE INCISION NEEDED TO BE ENLARGED AND THE PATIENT'S OUTCOME WAS AS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9529409 ↗
• MalfunctionJul 3, 2019Failure to Unfold or Unwrap; Failure to Eject; Failure to Unfold or Unwrap; Failure to Eject

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WHILE BEING INJECTED, THE LENS GOT STUCK INSIDE THE EYE AND IT DID NOT UNFOLD PROPERLY (SOMETHING INVOLVING THE HAPTIC). THE LENS WAS REMOVED IN PIECES AND DISCARDED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND SUTURES PERFORMED. THE PATIENT IS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759962 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL ZCB00 +13.5 DIOPTER), THE PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). REPORTEDLY, TREATMENT FOR TASS WAS ADMINISTERED ACCORDINGLY. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7713319 ↗
• MalfunctionJan 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DOCTOR NOTICED THAT THE LATHE LINES ON A ZCB00 13.5 DIOPTER INTRAOCULAR LENS (IOL) WERE FAINT/NOT PROMINENT AFTER IMPLANTATION. REPORTEDLY, THE LENS REMAINS IMPLANTED AND THERE IS NO INTERVENTION PLANNED. THERE WERE NO PATIENT SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202461 ↗
• MalfunctionOct 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING HANDLING, BUT PRIOR TO INSERTION, SOME FINE DEBRIS WAS NOTICED ON THE OPTIC OF A ZCB00 13.5 DIOPTER INTRAOCULAR LENS (IOL). ALSO, IT WAS REPORTED THAT THE PLASTIC PIECE THAT THE LENS COMES IN LOOKED DAMAGED, BUT THE BOX AND STERILE POUCH WERE INTACT. THE LENS WAS NOT LOADED AND THE SAME MODEL AND DIOPTER WAS IMPLANTED. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6975397 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD CATARACTS DONE LAST (B)(6). THE PATIENT'S RIGHT EYE IS STELLAR, HOWEVER THE LEFT EYE HAS A GHOST REFLECTIONS AND AN IMAGE OF A FLY WING IN LOWER LIGHTS OFF HEADLIGHTS AND LED LIGHTS. THE IRREGULARITIES DISAPPEARS IF THE PATIENT LOOKS UP. THE PATIENT AND HER PHYSICIAN ARE DISCUSSING THE POSSIBILITY OF A FLAWED OR WRONG IOL IN THAT LEFT EYE. PATIENT STATED THAT SHE HAS GREAT VISION WITH THE RIGHT EYE, BUT THIS LEFT EYE IS QUITE BOTHERSOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 6559925 ↗
• InjuryApr 4, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT HAD A ZCB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN THE FIRST EYE IN (B)(6) AND THE PATIENT ENDED UP -2.5 (REPORTED GREAT) SPHERICAL EQUIVALENT (SE). THE AXIAL LENGTH FOR THIS EYE IS 26.3. THE 2ND EYE WAS DONE 2 WEEKS LATER AND THE AXIAL LENGTH FOR THE 2ND EYE IS 26.05 AND SO THE PHYSICIAN WENT WITH A 13.5 DIOPTER LENS. HOWEVER, THE PATIENT'S POST OP REFRACTION RESULT WAS AT +6.0 NEAR DISTANCE. THROUGH FOLLOW-UP IT WAS CONFIRMED THAT THE BIOMETRY OF THE PATIENT BETWEEN BOTH EYES WAS FAIRLY SYMMETRIC AND IMMEDIATE POST-OP REFRACTION SHOWED A SIGNIFICANT HYPEROPIC SHIFT, WHICH HAS REMAINED CONSISTENT OVER THE PAST 1.5 MONTHS. THE PHYSICIAN HAS RULED OUT ANY MACULAR PATHOLOGY AND STATED THERE IS NO INDICATION THE IOL IS DISPLACED, DECENTERED, OR TILTED. THE DOCTOR BELIEVES THE IOL IS MISLABELED. THEY DISCUSSED EVALUATING THE PATIENT ONCE AGAIN TO CHECK FOR MARKED STEEPENING OF THE CORNEA, DRY EYE, OTHER OCULAR SURFACE ISSUES. THE PHYSICIAN STATED HE WILL LIKELY PROCEED WITH AN EXPLANT IN NEAR FUTURE AND WILL RETURN THE IOL IN HOPES OF DETERMINING IF THE IOL WAS INDEED MISLABELED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6459225 ↗
• MalfunctionOct 6, 2016Torn Material; Torn Material

  THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE RIGHT EYE OF A MALE PATIENT. AFTER INSERTION IT WAS OBSERVED THAT THE TRAILING HAPTIC WAS TORN. THE LENS WAS CUT OUT OF THE EYE AND REPLACED WITH ANOTHER IMPLANT. THERE WAS NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6008166 ↗