TECNIS CL IOL Z9002 (REF Z900200250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474530799), received between Oct 5, 2016 and Jan 27, 2022 — classified as 5 injuries, 3 malfunctions.

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

• MalfunctionJan 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC SHEARED WHEN IMPLANTING INTO PATIENT'S RIGHT EYE. THE TECHNICIAN WAS NEW AND THE EVENT COULD BE DUE TO USE ERROR, HOWEVER, THE SAME COULD NOT BE CONFIRMED. THE LENS WAS INSERTED INTO THE EYE, HOWEVER, WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377698 ↗
• MalfunctionSep 23, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON NOTICED THE TRAILING HAPTIC WAS NOT ATTACHED TO THE INTRAOCULAR LENS (IOL) DURING INSERTION INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS THEN CUT OUT AND REMOVED WITHOUT ANY INCIDENT. ANOTHER COMPETITOR LENS WAS PLACED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523899 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BENT UPON INSERTION INTO EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182415 ↗
• InjuryAug 18, 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 OPERATIVE EYE DUE TO ANISOMETROPIA. THERE WAS NO INDICATION OF PATIENT INJURY OR THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10423239 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S DAUGHTER REPORTED THAT HER MOTHER HAS BEEN HAVING LIGHT SENSITIVITY ISSUE SINCE HER CATARACT SURGERY. THE PATIENT STARTED TO EXPERIENCE PAIN AROUND THE LEFT EYE SOMETIME IN (B)(6) 2017. WHEN THIS OCCURRED THE PAIN LEVEL WAS BETWEEN 5-6. THE PATIENT SHARED THIS INFORMATION WITH HER DOCTOR IN (B)(6) 2018 AND WAS PRESCRIBED WITH SOME EYE DROPS FOR THE PAIN. THE DOCTOR INFORMED THE PATIENT THAT THE PAIN IS DUE TO THE SURGERY, SO SHE CONTINUED TO USE THE EYE DROP WHEN SHE WAS EXPERIENCING THE PAIN WHICH REPORTEDLY COMES AND GOES. THE PATIENT CHANGED INSURANCE AND SWITCHED DOCTOR AND THE NEW DOCTOR ADVISED HER TO STOP USING THE EYE DROP FOR PAIN. THE PATIENT IS CURRENTLY NOT USING ANYTHING FOR THE PAIN. IT WAS INDICATED THAT THE PATIENT STILL OCCASIONALLY FEELS PAIN AROUND HER LEFT EYE AND THE PAIN LEVEL IS 3. IT WAS NOTED THAT THE LIGHT SENSITIVITY STARTED MIDDLE OF 2018. THE LIGHT SENSITIVITY WAS COMMUNICATED TO THE PATIENT'S NEW DOCTOR WHO CHECKED THE IMPLANT AND TOLD THE PATIENT THAT THE LEFT LENS DOESN¿T APPEAR TO BE CENTERED. THE DOCTOR ALSO TOLD THE PATIENT TO CONTINUE USING THE EYE DROP FOR DRY EYES AND THAT SHE WOULD NEED TO USE SUNGLASSES. THE PATIENT INDICATED TO H

  Patient problems: No Code Available; Pain; Visual Disturbances

  MAUDE report 9737379 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +25.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING RESIDUAL REFRACTIVE ERROR - BLURRY. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9132169 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9002 INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT LATER EXPLANTED/EXCHANGED DUE TO THE PATIENT EXPERIENCING RESIDUAL MYOPIA. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. THE PATIENT HAS RECOVERED POST EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737705 ↗
• InjuryOct 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR. AT EXPLANT THERE WAS NO COMPLICATION OR INJURY. A NEW LENS WAS IMPLANTED. CURRENT PATIENT STATUS IS NOTED AS THE PATIENT HAS RECOVERED.

  Patient problems: No Code Available

  MAUDE report 6001430 ↗