TECNIS CL IOL Z9002 (REF Z900200230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 05050474530751), received between Sep 18, 2016 and Nov 29, 2022 — classified as 11 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S LEFT EYE, IT WAS NOTED THAT THE TRAILING HAPTIC WAS DAMAGED. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON LENS, MODEL ZA9003 OF 23.0 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883266 ↗
• MalfunctionMay 14, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CRACKED AND WAS PARTIALLY INSERTED INTO PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402834 ↗
• MalfunctionMay 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SPLIT AS THE SURGEON WAS INSERTING IT INTO THE PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402777 ↗
• MalfunctionMay 7, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LENS SPLIT DURING INSERTION, RESULTING IN THE SURGEON PUTTING IN ANOTHER LENS. THERE WAS PATIENT CONTACT, BUT NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14325406 ↗
• MalfunctionApr 6, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD DETACHED HAPTIC. THERE WAS CONTACT WITH PATIENT'S LEFT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14026580 ↗
• MalfunctionMar 3, 2022Failure to Fold; Use of Device Problem; Material Split, Cut or Torn; Failure to Fold; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE DURING THE INITIAL PROCEDURE DUE TO A LOADING ISSUE, FOLDING ISSUE, AND IOL TORN. MICRO CUTTER AND GRABBER WERE USED TO REMOVE THE LENS. THERE WAS NO INCISION ENLARGEMENT. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY COMPLICATIONS WHILE IN THE OPERATING ROOM, BUT IT IS UNKNOWN HOW THE PATIENT WAS AFTER LEAVING THE OPERATING ROOM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664667 ↗
• InjuryNov 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN SURGEON PLACED A Z9002 MODEL INTRAOCULAR LENS(IOL) IN THE PATIENT'S OPERATIVE EYE, HE NOTICED THAT THE IOL WAS RIPPED AND IT WAS NOT DUE TO THE INJECTOR. THE TORN LENS WAS RETRIEVED FROM EYE. THE INCISION WAS MADE LARGER AND NO SUTURES WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12741003 ↗
• MalfunctionNov 1, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A MARK ON THE LENS. THE LENS WAS IMPLANTED AND REMAINS IMPLANTED. THERE ARE NO PLANS TO EXPLANT THE LENS. THERE WAS NO INCISION ENLARGEMENT OR NO EXTRA SURGICAL STEPS THAT TOOK PLACE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS APPEARS TO HAVE A SCRATCH ON THE ANTERIOR SURFACE OF THE LENS. THE CUSTOMER REPORTED LOOKING CLOSELY AT THE LENS PRIOR TO PUTTING IN THE CARTRIDGE TO RULE OUT LOADING ERROR AND CARTRIDGE ERROR. THE LENS COMES OUT OF THE PACKAGE THIS WAY. THE LENS LOOKS GOOD TO THE NAKED EYE, BUT AS YOU LOOK WITH THE MICROSCOPE THE LENS ALMOST LOOKS LIKE IT HAS A FINE DUST OR POWDER ON IT. ESPECIALLY NOTED AS YOU FLIP THE LENS OVER AND TILT AT AN ANGLE. THIS IS EASIER TO SEE AFTER THE LENS IS WET (BSS) WHICH IS WHY IT IS NOT NOTICED UNTIL IN THE EYE. THERE IS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729377 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO PATIENT'S LEFT EYE AND REMOVED IN THE SAME PROCEDURE DUE TO A CREASE IN THE LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT WAS DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724305 ↗
• MalfunctionSep 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) HAPTIC WAS NOT ATTACHED WHEN THE LENS WAS INSERTED INTO THE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517132 ↗
• InjurySep 21, 2021Break; Device Difficult to Setup or Prepare; Inaccurate Delivery; Mechanical Jam; Break; Device Difficult to Setup or Prepare; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS (IOL) WAS STUCK ON INJECTOR, WAS CRACKED AND ALSO DOCTOR FELT RESISTANCE. THE EVENT WAS OBSERVED WHILE INSERTING LENS INTO PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY REPORTED. THE LENS WAS PARTIALLY INSERTED, INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE PATIENT'S EYE AND PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF SAME MODEL AND DIOPTER. PATIENT WAS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12511099 ↗
• MalfunctionSep 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, HOWEVER, A TEAR IN THE OPTIC WAS OBSERVED AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL DURING THE SAME PROCEDURE. THE REPORTER STATED THE TEAR WAS MOST LIKELY DUE TO A LOADING ISSUE, HOWEVER, COULD NOT BE CONFIRMED. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE REMOVED LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456557 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE (OS). THERE WAS A BROKEN HAPTIC DUE TO A LOADING ISSUE. THE LENS WAS REMOVED AND REPLACED. THE PROCESS WAS COMPLETED SUCCESSFULLY WITH ANOTHER Z9002 LENS. PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773621 ↗
• MalfunctionMar 26, 2021Difficult to Insert; Inaccurate Delivery; Difficult to Insert; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED AND REPLACED IN THE SAME PROCEDURE AS THE LENS FLIPPED AND WAS NOT IN CORRECT POSITION. THERE WAS INCISION ENLARGEMENT AND ANOTHER LENS OF SAME MODEL AND SAME DIOPTER POWER, WITH SERIAL NUMBER (B)(4) WAS USED AS REPLACEMENT. THE PATIENT IS DOING GREAT POST OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11575817 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT HAPTIC PRIOR TO INSERTION. IT WAS STATED THAT THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490429 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS(IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE AND THE CAPSULE APPEARED TO BREAK. SURGEON REMOVED THE LENS, CASE WAS ABORTED AND PATIENT WAS SENT TO RETINA SPECIALIST. NO LENS WAS IMPLANTED. PROCEDURE WAS NOT COMPLETED. THE EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11159965 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) OPTIC TORE UPON INSERTION INTO THE PATIENT'S LEFT EYE. LENS WAS REMOVED AND REPLACED WITH A SAME MODEL AND DIOPTER LENS DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. PATIENT OUTCOME WAS REPORTED TO BE FINE POST OPERATIVELY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125781 ↗
• MalfunctionDec 28, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS FULLY INSERTED THEN REALIZED THERE WAS A LOADING ERROR AND NOTICED THE HAPTIC WAS BENT CAUSING THE LENS TO BE REMOVED AND REPLACED WITH A BACK-UP LENS OF SAME MODEL AND DIOPTER. EVENT WAS OBSERVED AFTER INSERTION AND THERE ARE NO PATIENT INJURY OR INTERVENTIONS PERFORMED. PATIENT IS DOING OK POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11085265 ↗
• InjuryOct 23, 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 DUE TO UNEXPECTED POST-OP REFRACTION. THIS WAS REPLACED WITH MODEL ZA9003 23.5 DIOPTER LENS. THE PATIENT HAS RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10731460 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INTRAOCULAR LENS IMPLANTED IN HER LEFT EYE ON (B)(6) 2020 AFTER CATARACT SURGERY. HER VISION IS NOW VERY DISTORTED. SHE IS WANTING HER VISION TO BE CORRECTED. REPORTEDLY IMMEDIATELY AFTER SURGERY HER DISTANCE VISION WAS GOOD, HOWEVER AFTER ABOUT A WEEK, IT BEGAN TO LOOK WORSE. SHE NOTICED IT WHEN DRIVING BECAUSE THE LINES IN THE ROAD WERE WAVY. SHE STATED EVERYTHING LOOKS DISTORTED, AND BLURRY IN PERIPHERAL VISION. SHE IS SEEING STREAKS OF YELLOW, AND FLASHES OF LIGHT. SHE SAID SHE CAN DRIVE BUT THE LINES IN THE ROAD LOOK WAVY, LIKE THERE IS A KINK IN THE LENS. WHEN SHE MENTIONED THIS TO HER DOCTOR, HE ADVISED HER TO HAVE YAG SURGERY WHICH WAS CONDUCTED ON (B)(6) 2020, AND HER VISION IS NOW WORSE (MORE BLURRY). WHEN SHE TOLD HER DOCTOR THIS, SHE WAS TOLD THE LENS WAS IN PLACE, BUT THAT SHE HAD AN AGING RETINA. HER DOCTOR DIDN'T ADVISE ANY FURTHER COURSE OF ACTION. HE TOLD HER SHE HAS BENEFITED THE BEST SHE CAN FROM THIS SURGERY. SHE IS SCHEDULED TO SEE HER DOCTOR ON LATER DATE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 10335407 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT¿S LEFT EYE (OS) IN SECONDARY SURGICAL PROCEDURE DUE TO DYSPHOTOPSIA. THE SYMPTOMS DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9935701 ↗
• MalfunctionMar 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN REMOVING FROM PACKAGING THE INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8407246 ↗
• MalfunctionDec 21, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS BENT WHEN EXITING THE CARTRIDGE. REPORTEDLY, THE LENS WAS NOT STUCK IN THE CARTRIDGE. DOCTOR DECIDED TO USE ANOTHER LENS, THE SAME SIZE AND MODEL. NO SURGICAL INTERVENTION REQUIRED. NO HARM TO PATIENT AND THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192555 ↗
• MalfunctionDec 2, 2018Separation Problem; Separation Problem

  THE SURGERY CENTER REPORTED OF A DETACHED HAPTIC OF AN INTRAOCULAR LENS (IOL), MODEL Z9002 (23.0 DIOPTER). THAT THE HAPTIC WAS PINCHED AND PULLED OFF DURING IMPLANTATION. THERE WAS NO PATIENT INJURY AND NO SURGICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123096 ↗
• MalfunctionNov 6, 2018Crack; Crack

  IT WAS REPORTED THAT WHEN INSERTING THE Z9002 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THE SURGEON NOTICED A CRACK IN THE LENS. THE HAPTIC TOUCHED THE PATIENT'S EYE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ANOTHER Z9002, SAME DIOPTER, WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING GOOD POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041000 ↗