TECNIS CL IOL Z9002 (REF Z900200240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474530775), received between Sep 17, 2016 and Dec 30, 2021 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT, DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THE LENS WAS FOLDED ON ITSELF WHEN IT DEPLOYED OUT OF THE CARTRIDGE. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED AND NO INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122577 ↗
• MalfunctionAug 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE FROM THE PATIENT'S RIGHT EYE DUE TO IOL TORN. THIS WAS REPLACED WITH THE SAME MODEL AND DIOPTER SIZE JNJ IOL. THE SUSPECT PRODUCT WAS DISCARDED. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354646 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE. HOWEVER, IT WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER DUE TO TORN HAPTIC. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING OK POST-OPERATION. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757754 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) GOT STUCK, BUT THEN RELEASED AND WAS TORN IN THE PATIENT'S RIGHT (OD) EYE. THE IOL WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING OK POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506853 ↗
• MalfunctionMar 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AS A TECNIS INTRAOCULAR LENS (IOL) WAS COMING OUT OF THE SHOOTER AND INTO THE PATIENT'S EYE, IT TORE, AND THE TEAR ACTUALLY RENTED THE POSTERIOR CAPSULE. THE LENS WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS OF THE SAME MODEL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED, NO COMPLICATION. THE PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11500067 ↗
• MalfunctionFeb 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) TORE DURING INSERTION INTO THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283428 ↗
• MalfunctionJan 7, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD UPON INSERTION AND HAD TO BE REMOVED AND REPLACED WITH ANOTHER LENS. THERE IS NO INDICATION OF PATIENT INJURY OR THAT SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561709 ↗
• MalfunctionDec 12, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9463599 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9455983 ↗
• MalfunctionJan 16, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT WATER MARK WAS NOTICED ON THE LENS BEFORE REMOVING FROM PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8255437 ↗
• InjuryDec 6, 2018Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT PATIENT HAD A BLURRED VISION APPROXIMATELY AFTER 4-MONTH POST-IMPLANTATION OF MODEL Z9002 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) IN PATIENT'S LEFT EYE (OS). DOCTOR REPORTEDLY NOTICED THAT LENS HAD BECOME DARK. AS A RESULT, IOL WAS EXPLANTED AS PLANNED. INITIAL POST-SURGICAL VA 10/10. PATIENT COMPLAINING OF BLURRED VISION APPROXIMATELY 4 MONTHS POST-SURGICAL; HOWEVER, THE VA WAS 10/10. THE REPLACEMENT LENS WAS A NON-JJSV IOL. PATIENT IS DOING FINE WITH PERFECT VISION POST-REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8136684 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS MISSING WHEN THE INTRAOCULAR LENS WAS OPENED BEFORE LOADING. ALSO NOTED THE HAPTIC WAS BROKEN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8067913 ↗
• InjuryNov 28, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG STARTED FALLING TO THE BACK OF THE EYE BECAUSE OF WEAK ZONULES AFTER A Z9002 24.0 DIOPTER INTRAOCULAR LENS WAS FULLY INSERTED INTO THE EYE. THEREFORE, A VITRECTOMY WAS PERFORMED, THE LENS WAS REMOVED, AND THE PATIENT WAS SENT HOME APHAKIC. REPORTEDLY, THERE WAS NO PATIENT INJURY. THERE WAS NO INCISION ENLARGEMENT MADE AND SUTURES WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7065416 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL Z9002, +24.0 DIOPTERS) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FORM THE LEFT EYE OF A FEMALE PATIENT BECAUSE OF A REFRACTIVE SURPRISE. REPORTEDLY, ANOTHER LENS SAME MODEL SMALLER DIOPTER (+21.0) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6629025 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF Z9002 24.0 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT'S CAPSULE BAG WAS DAMAGED. THE LENS WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER LENS WITH NO OTHER ISSUES WITH THE EYE. A VITRECTOMY AND AN INCISION ENLARGEMENT WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO PRODUCT QUALITY ISSUE.

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

  MAUDE report 6434503 ↗
• InjuryNov 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT SHE HAD A CATARACT SURGERY ON HER LEFT EYE ON (B)(6) 2016. THE NIGHT AFTER THE SURGERY, SHE NOTICED A DARK AREA AT THE EXTREME LEFT EDGE OF HER VISUAL FIELD. IT LOOKED AS THOUGH THERE WAS AN OBJECT OBSTRUCTING THE LIGHT HOVERING TO THE LEFT OF HER EYE. IT MOVES WHEN SHE LOOKS AROUND, SHE ALSO EXPERIENCED DISTURBING BRIGHT FLASHES OF LIGHT THAT SEEMED TO COINCIDE WITH EYE MOVEMENT. SHE REPORTED BOTH ISSUES TO HER SURGEON. HER PHYSICIAN STATED THAT THE FLASHING LIGHT IS NORMAL. THE FLASHES HAVE ALMOST GONE AWAY; HOWEVER, THE DARK SHADOW IS STILL EXIST AND HAS BECOME AN ANNOYANCE. THE AMOUNT OF HER VISUAL FIELD THAT'S OCCLUDED IS TRIFLING. SHE THINKS THAT THE IOL MAY NOT BE PLACED CORRECTLY, OR THAT SOMETHING ELSE HAS GONE WRONG. NOW SHE CAN SEE HER PULSE IN THE LEFT EYE. THIS MANIFESTS ITSELF AS A BUNCH OF INVALID LIKE LINES ACROSS THE FIELD OF VISION FLASHING ON AND OFF WITH THE RHYTHM OF HER HEART. SHE STATED HER EYE SIGHT NOW IS 20/40 AND SHE HAS A BLINK SPOT TO THE CORNER OF HER EYE AND DRY EYE VISION. FURTHERMORE, THE PATIENT FEELS LIKE SHE IS WEARING HORSE BLINDERS-DYSPHOTOPSIA. PATIENT NOTED CONCOMITANT MEDICAL PRODUCTS EYE DROPS, GATIFLOXACIN, ILEVRO,

  Patient problems: Dry Eye(s); Flashers; Halo

  MAUDE report 6082068 ↗
• InjurySep 17, 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 DOCTOR NOTICED THERE WAS NOT ENOUGH CAPSULE FOR THE LENS. THE LENS WAS REMOVED AND AN ANTERIOR CHAMBER LENS IMPLANTED. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5958979 ↗