TECNIS CL IOL Z9002 (REF Z900200175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474530645), received between Sep 19, 2016 and Feb 18, 2022 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Torn Material” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO LENS DISLOCATION. THE PATIENT REPORTED THAT THEIR VISION WAS NEVER GOOD AFTER THE CATARACT SURGERY. THERE WAS A CAPSULE TEAR AND THE DOCTOR¿S NOTE INDICATED THAT HE COULD SEE SOME VERY MILD BORDER DISTORTION FROM WHAT LOOKED LIKE THE USE OF IRIS HOOKS. THERE WAS VITREOUS STRAND RUNNING TO THE CORNEA FROM THE PUPIL AT 11 O'CLOCK. THIS WAS QUITE BROAD, AND IT WAS DISPLACING THE IOL TO THE TEMPORAL SIDE. THE LENS ITSELF WAS DECENTERED ABOUT 3 MM AND HE COULD SEE THE EDGE OF THE OPTIC IN THE PUPIL. UNDERNEATH THE LENS, THERE APPEARED TO BE A CAPSULAR BAG WITH A RATHER SMALL RHEXIS OPENING THAT WAS FIBROSED. THERE WAS VITREOUS COMING THROUGH THE CAPSULAR BAG TO THE ANTERIOR CHAMBER. THE DOCTOR COULD SEE TENSION LINES FROM VITREOUS TRACTION. THERE WERE PARS PLANA VITRECTOMY, OPTIC CAPTURE OF THE IOL AND LIMBAL RELAXING INCISIONS (LRI) PERFORMED. THERE WERE NO SUTURES REQUIRED. A NON-JOHNSON & JOHNSON LENS, 18.5 DIOPTER WAS USED AS A REPLACEMENT IOL. THE PATIENT OUTCOME WAS REPORTED TO BE EXCELLENT, AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 13564330 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS (IOL) CRACKED WHILE BEING INJECTED INTO THE EYE. THE LENS DID TOUCH THE PATIENT. THE LENS WAS CUT OUT AND A NEW LENS WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350181 ↗
• InjuryMay 20, 2021Adverse 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 RIGHT EYE DUE TO IOL WAS PLACED IN SULCUS CAUSING CYSTOID MACULAR EDEMA (CME). IT WAS STATED THAT PARS PLANA VITRECTOMY (PPV) WAS PERFORMED. THE IOL WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. IT WAS LEARNED THAT THE SUSPECT IOL WAS DISCARDED. THE PATIENT OUTCOME WAS NOTED AS VISION HAS IMPROVED, CME STILL PRESENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Macular Edema; Visual Impairment

  MAUDE report 11853582 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION OF A MODEL Z9002 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, A VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Vitrectomy

  MAUDE report 8844378 ↗
• MalfunctionFeb 8, 2019Crack; Crack

  REPORTEDLY, A Z9002 17.5 DIOPTER WAS NOT USED DUE TO A CRACK OBSERVED WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. THERE WAS NO SURGICAL INTERVENTION PERFORMED AND PATIENT IS DOING FINE POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324179 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 17.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO INTERNAL ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT AND NO COMPLICATIONS. THE REPLACEMENT LENS WAS A ZCT225 18.0 DIOPTER INTRAOCULAR LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8220383 ↗
• InjuryNov 23, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.5. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8099567 ↗
• MalfunctionNov 10, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS SHEARED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7021779 ↗
• MalfunctionJun 15, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED TORN ONCE IT WAS INSERTED INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS CUT IN HALF, AND REMOVED FROM THE EYE WITH NO INCIDENT. THE INCISION WAS NOT ENLARGED. A NEW LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645716 ↗
• InjuryMar 6, 2017Difficult To Position; Positioning Problem; Difficult To Position; Positioning Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. THIS LENS WAS A REPLACEMENT LENS FOR AN EARLIER LENS EXPLANT. DURING THE PROCEDURE, THE LENS WENT INTO THE EYE UPSIDE DOWN. THE DOCTOR TRIED TO FIX IT BUT THE LENS COULD NOT SEEM TO STAY CENTERED IN THE BAG. THE LENS CONTINUED TO BE DECENTERED. THIS LENS WAS REMOVED AND REPLACED WITH A NON-AMO DEVICE. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY OR PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES SERIAL NUMBER (B)(4) AND A SEPARATE MDR REPORT WILL BE FILED FOR THE EXPLANTED LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382641 ↗
• InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT DUE TO A REFRACTIVE ERROR AND UNEXPECTED POST OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL, SAME SIZE LENS. HOWEVER, DURING THIS REPLACEMENT, THE LENS WENT INTO THE EYE UPSIDE DOWN. THIS LENS WAS REMOVED AND REPLACED WITH A NON-AMO DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE SERIAL NUMBER (B)(4) AND A SEPARATE MDR REPORT WILL BE FILED FOR THE REPLACEMENT LENS.

  Patient problems: No Code Available

  MAUDE report 6382601 ↗
• MalfunctionSep 19, 2016Torn Material; Torn Material

  AN INTRAOCULAR LENS (IOL) TORE DURING INSERTION INTO THE EYE. THE IOL WAS REMOVED WITHOUT DIFFICULTY AND ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5961189 ↗