TECNIS CL IOL Z9002 (REF Z900200140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474530577), received between Oct 5, 2016 and Aug 26, 2021 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionAug 26, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE AND AT THAT POINT IT WAS REALIZED THAT THE HAPTIC WAS BROKEN. THIS WAS A LOADING ERROR AND THE LENS WAS CUT OUT OF THE EYE AND REPLACED WITH ANOTHER LENS. THE PATIENT WAS FINE, THERE WERE NO COMPLICATIONS AND THE PATIENT DID NOT NEED VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369013 ↗
• InjuryJul 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 +14.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT WANTED NEAR VISION FOR THIS EYE. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7721775 ↗
• MalfunctionJun 11, 2018Bent; Bent

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 14.0 DIOPTER LENS WAS BENT UPON ADVANCEMENT/WHEN INSERTING INTO THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589623 ↗
• InjuryDec 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. THERE WAS NO PATIENT INJURY AND THE PATIENT HAS RECOVERED. THE LENS WAS REPLACED WITH THE SAME MODEL, A LARGER 19.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7102199 ↗
• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A LARGER, 16.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT NO SUTURES AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6730162 ↗
• MalfunctionJun 7, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED TORN WHEN OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6620613 ↗
• InjuryMar 23, 2017Break; Break

  THE INTRAOCULAR LENS (IOL) WAS HALF INJECTED AND THEN REMOVED WHEN THE PATIENT MOVED. THE TECHNICIAN TRIED TO RELOAD IT AND ENCOUNTERED LOADING ISSUES WHICH RESULTED IN HAPTIC BREAKAGE. AN INCISION ENLARGEMENT WAS REQUIRED. A NEW IOL WAS IMPLANTED (SAME MODEL AND DIOPTER). THE PATIENT WAS DOING FINE POST-OP. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6430250 ↗
• MalfunctionOct 5, 2016Torn Material; Torn Material

  IT WAS REPORTED THAT THE TRAILING HAPTIC WAS SHEARED WHEN PLACING IT INTO THE PATIENTEYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6001827 ↗