TECNIS CL IOL Z9002 (REF Z900200165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474530621), received between Aug 26, 2016 and Jun 4, 2021 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Material Split, Cut or Torn; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD CORRECTLY AND IT TORE WHEN THE LENS WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER (SN (B)(4)). HOWEVER, THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST-OP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942727 ↗
• MalfunctionMay 27, 2021Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON IMPLANTATION AS THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED, THE SURGEON NOTICED THAT THE OPTIC WAS CRACKED / TORN. THE IOL WAS REMOVED WITHOUT COMPLICATION WITHIN THE SAME PROCEDURE, AND WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891842 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE DURING THE INITIAL PROCEDURE BECAUSE THE SURGEON NOTICED NO SUPPORT FOR THE LENS IN THE CAPSULE BAG. THE DOCTOR THEN WANTED TO USE AN ANTERIOR CHAMBER LENS. THERE WAS NO INCISION ENLARGEMENT REQUIRED, AND THE REMOVED LENS WAS DISCARDED. PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 11277161 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +16.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. LENS WITH SAME MODEL AND HIGHER DIOPTER OF +18.0 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9132148 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULE TORE UPON THE INSERTION OF A Z9002 16.5 DIOPTER INTRAOCULAR LENS (IOL). A REPLACEMENT LENS HAD TO BE PUT IN THE SULCUS. NO SURGICAL INTERVENTION REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 8502359 ↗
• MalfunctionNov 21, 2018Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE Z9002 INTRAOCULAR LENS (IOL) HAD A LOADING ERROR AND A TORN HAPTIC WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT WAS DOING WELL POST-OP. THE ACCOUNT COMMENTED THAT THE REMOVED LENS IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093897 ↗
• MalfunctionNov 16, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS OBSERVED BENT UPON OPENING OF THE PACKAGING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8081847 ↗
• MalfunctionNov 2, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +16.5 DIOPTER) HAD A BENT HAPTIC. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8035384 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT A Z9002, 16.5 DIOPTER INTRAOCULAR LENS (IOL) WHEN REMOVED FROM PACKAGING WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE SUSPECT PRODUCT WILL BE RETURNED. FOLLOW-UP CONFIRMED THAT DEFECT WAS THAT THE HAPTIC BENT WHEN THEY REMOVED THE PRODUCT FROM THE PACKAGING. CUSTOMER STATED THAT ALL SEALS WERE INTACT WHEN THEY REMOVED THE PRODUCT FROM PACKAGING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7954306 ↗
• MalfunctionMay 16, 2018Scratched Material; Scratched Material

  IT WAS NOTED THAT THERE WAS A SCRATCH ON THE CENTER OF THE LENS WHEN INSERTING IT INTO THE EYE. THE LENS WAS FULLY INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH THE SAME IOL MODEL AND DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517399 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO THE PATIENT'S VISION NOT BEING OPTIMAL AND NEEDING A DIFFERENT DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING EXCELLENT POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7405521 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE OUTCOME. THE LENS WAS EXPLANTED WITH NO COMPLICATION, NO INJURY AND NO ADDITIONAL PROCEDURES PERFORMED. THE LENS WAS REPLACED WITH A DIFFERENT MODEL WITH THE SAME DIOPTER SIZE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6681147 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PHYSICIAN STATED THAT THE PATIENT REQUIRED EXTRA PROCEDURES AND SUTURE AND THE FIRST LENS DID NOT REACH THE ACQUIRED EFFECT. THE LENS WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6616768 ↗
• InjuryFeb 7, 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 REMOVED DURING THE INITIAL SURGERY. DURING IMPLANT OF THE LENS, THE PATIENT HAD A TEAR IN HIS RIGHT EYE (CAPSULE) WHICH SPREAD AND REQUIRED THE DOCTOR TO PERFORM A VITRECTOMY. NO INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT WAS SENT HOME APHAKIC. THE PATIENT RETURNED AT A LATER DATE AND A SUCCESSFUL LENS IMPLANT WAS PERFORMED. THE PATIENT WAS REPORTED AS FINE. THERE WAS NO QUALITY ISSUE WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6309566 ↗
• MalfunctionOct 19, 2016Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS FIRST REPORTED THAT THE INTRAOCULAR LENS (IOL) DID NOT INSERT INTO THE PATIENT'S EYE AND HAD A MALFUNCTION. THE DOCTOR WAS ABLE TO REMOVE THE IOL AND USE A NEW ONE OF THE SAME MODEL AND DIOPTER. THE PATIENT IS FINE. DURING FOLLOW-UP, IT WAS FOUND THAT AFTER THE LENS WAS INSERTED IN THE EYE, THE DOCTOR DID NOT LIKE HOW THE LENS UNFOLDED IN THE EYE. THE LENS WAS CUT IN PIECES AND REMOVED FROM THE PATIENT WITH NO INCISION ENLARGEMENT, VITRECTOMY OR PATIENT INJURY. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS INSERTED WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6042657 ↗
• InjurySep 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN REMOVED WITHIN THE SAME PROCEDURE DUE TO PATIENT'S CAPSULE NOT SUPPORTING THE LENS. THE EVENT WAS NOT A PRODUCT QUALITY ISSUE. IT WAS ALL DUE TO THE CONDITION OF THE PATIENT'S EYE. THERE WAS NO INJURY POST OPERATIVELY. THERE WAS INCISION ENLARGEMENT WITH SUTURES BUT NO VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5925033 ↗
• InjuryAug 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPEROPIC REFRACTIVE SURPRISE AFTER IMPLANTATION OF A 16.5 DIOPTER Z9002 INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED AND REPLACED WITH A 21.0 DIOPTER Z9002 IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES OR OTHER PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5905702 ↗