TECNIS CL IOL Z9002 (REF Z900200155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474530607), received between Sep 19, 2016 and Aug 13, 2021 — classified as 5 injuries, 3 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 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.

• MalfunctionAug 13, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED DUE TO LOADING ISSUE. IT WAS NOTED THAT THERE WERE LENS SCRATCHES UPON INSERTION. THE SUSPECT IOL WAS REPLACED WITH BACK-UP IOL. NO ADVERSE EVENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321586 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS WHEN TRYING TO MOVE INTO POSITION THE BOTTOM HAPTIC WAS BENT AND WOULD NOT SLIDE INTO PLACE. THE DOCTOR MENTIONED IT LOOKED GOOD BUT THEN COULD SEE A SLIGHT BEND ON THE BOTTOM HAPTIC. THE LENS LOADED AND INSERTED FINE BUT UNDER THE MICROSCOPE HE COULD SEE IT WAS BENT. IT WAS A SILVER SERIES CARTRIDGE THAT WAS USED. THEN ANOTHER LENS SAME MODEL WAS USED AND IT WENT IN FINE. THERE WAS PATIENT CONTACT. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626119 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS (IOL) HAD BENT HAPTIC ISSUES AND THE CUSTOMER IS NOT SURE IF THEY'RE BENT UPON OPENING OR AFTER BEING LOADED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270723 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (Z9002 +15.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) IN A SECONDARY PROCEDURE DUE TO A RESIDUAL REFRACTIVE ERROR. NO INCISION ENLARGEMENT AND NO ADDITIONAL PROCEDURE WAS REQUIRED. A Z9002 +19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT'S OUTCOME WAS REPORTED BEGIN GOOD POST LENS EXCHANGE. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8579992 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON PLANNED TO USE INTRAOCULAR LENS WITH MODEL ZLB00 +16.0 DIOPTER FOR THE PATIENT, HOWEVER AS THE DOCTOR HAD TO PERFORM VITRECTOMY FOR THE PATIENT UNRELATED TO THE LENS THIS LENS WAS NOT USED. THERE WAS NO PATIENT CONTACT WITH THIS LENS. LATER THE SURGEON IMPLANTED TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +15.5 DIOPTER) AS THERE WAS TOO MUCH OF BLEEDING THE LENS WAS REMOVED FROM PATIENT¿S LEFT EYE IN THE SAME PROCEDURE. REPORTEDLY THE PATIENT GOT STITCHED UP AND LEFT THE SURGERY WITHOUT ANY LENS. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THERE WAS NO PRODUCT QUALITY ISSUE, NO INCISION ENLARGEMENT AND NO MEDICAL INTERVENTION REQUIRED. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8070558 ↗
• InjuryDec 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +15.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF HYPER OPTIC OUTCOME OBSERVED DURING POST EXAMINATION, (B)(6) 2017. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT A MONOFOCAL LENS (MODEL Z9002, +17.5) WAS IMPLANTED AS A REPLACEMENT LENS. THERE WAS NO PATIENT INJURY REPORTED. AND PATIENT WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7115268 ↗
• InjuryDec 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR FROM THE PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY AND THE PATIENT HAS RECOVERED. THE LENS WAS REPLACED WITH THE SAME MODEL, A LARGER, 16.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7102143 ↗
• InjurySep 19, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT NOT BEING ABLE TO SEE DISTANCE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. ADDITIONALLY, THERE WAS NO PATIENT INJURY POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5959986 ↗