TECNIS CL IOL Z9002 (REF Z900200220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 05050474530737), received between Aug 24, 2016 and Apr 5, 2023 — classified as 15 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THE Z9002 INTRAOCULAR LENS (IOL) WAS DAMAGED WHILE LOADING AND EXTENT OF PATIENT CONTACT IS UNKNOWN. IT IS UNKNOWN IF THE INCISION WAS ENLARGED, UNKNOWN IF SUTURE(S) WERE REQUIRED, AND UNKNOWN FOR VITRECTOMY. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686938 ↗
• InjuryFeb 2, 2023Adverse 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 DURING A SECONDARY SURGICAL PROCEDURE DUE TO ANISOCORIA IN THE LEFT EYE. THE ISSUE WAS FIRST OBSERVED DURING THE POST OPERATIONAL EXAMINATION. THE DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (DCB00, 21.0 D) WAS USED. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS INDICATED. THE PATIENT HAS FULLY RECOVERED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16286680 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S LEFT EYE. AFTER KUGLEN HOOK WAS REMOVED IOL WAS FOUND FREE IN THE ANTERIOR CHAMBER AND CAPSULAR REMAINS. THE CAPSULAR BAG BROKE, REQUIRING AN ANTERIOR IOL TO BE IMPLANTED. THE IOL WAS REMOVED AND REPLACED WITH A NON-JOHNSON AND JOHNSON ANTERIOR CHAMBER LENS OF 18.5 DIOPTER AFTER IRIDOTOMY WAS PERFORMED. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. NO VITRECTOMY WAS REQUIRED. THERE WAS A DELAY OF 15 MINUTES IN THE PROCEDURE. THE PATIENT WAS PRESCRIBED MEDICATION, BUT DID NOT SEEK MEDICAL ATTENTION. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT'S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. THE PATIENT OUTCOME POST-OP IS GOOD AND THE PATIENT HAS FULLY RECOVERED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14109824 ↗
• MalfunctionMar 16, 2022Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED AS THE LENS WAS SCRATCHED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13779253 ↗
• MalfunctionMar 7, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SPLIT UPON INSERTION INTO PATIENT'S OPERATIVE EYE AND THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677788 ↗
• MalfunctionNov 12, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT IT APPEARS AN INTRAOCULAR LENS (IOL) HAS 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 CAME 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. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807878 ↗
• MalfunctionNov 12, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT IT APPEARS AN INTRAOCULAR LENS (IOL) HAS 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 CAME 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. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807775 ↗
• MalfunctionNov 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), FULLY IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO THE LENS BEING TORN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800885 ↗
• MalfunctionOct 29, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THE SURGEON NOTICED SCUFFING/ SCRATCHING ON THE ANTERIOR LENS SURFACE AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THE SURGEON ROTATED THE LENS SO THE SCUFF IS SUPERIOR WHEN NOTICED AND HIDDEN UNDER UPPER EYELID. THERE WAS NO INCISION ENLARGEMENT AND NO EXTRA SURGICAL STEPS WERE REQUIRED. THE IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S EYE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO SERIOUS INJURY, NO SUTURE(S), AND NO VITRECTOMY. ACCOUNT ALSO STATED THE LENS CAME OUT OF THE PACKAGING THIS WAY. THE LENS LOOKS GOOD TO THE NAKED EYE, BUT AS YOU LOOK WITH THE MICROSCOPE THE LENS ALMOST LOOK LIKE THEY HAVE A FINE DUST OR POWDER ON IT. IT IS ESPECIALLY NOTED AS YOU FLIP THE LENS OVER AND TILT IT 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. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724547 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628566 ↗
• MalfunctionAug 24, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A BACK UP LENS (SAME MODEL/DIOPTER) DURING THE INITIAL PROCEDURE DUE TO THE LENS BEING TORN. THERE WAS NO HARM TO THE PATIENT AND SHE HAS RECOVERED FROM THE SURGERY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363118 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Material Split, Cut or Torn; Break; Inaccurate Delivery; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED AND REPLACED WITH A BACKUP LENS DURING THE INITIAL PROCEDURE DUE TO IT BEING TORN. THE CUSTOMER STATED THAT THE OUTCOME DID NOT INTERFERE WITH THE ACTIVITIES OF THE PATIENT¿S DAILY LIFE, AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170795 ↗
• MalfunctionJul 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO PATIENT'S EYE IT WAS NOTED TO BE TORN. LENS WAS CUT OUT AND PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139075 ↗
• MalfunctionJun 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE LENS TORE AS THERE WAS CARTRIDGE OR AN INJECTOR ERROR. THE DEVICES HAVE BEEN DISCARDED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925895 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC. AN EMERALDC CARTRIDGE WAS USED. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611556 ↗
• MalfunctionMar 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS (IOL) TORE WHILE INSERTING THE LENS INTO PATIENT'S LEFT EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. PATIENT WAS DOING GOOD POST-OP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419251 ↗
• MalfunctionFeb 9, 2021Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SURGEON THOUGHT THE INTRAOCULAR LENS (IOL) GOT STUCK TO PLUNGER OF THE INJECTOR. THERE WAS TEAR IN THE OPTIC. THERE WAS PATIENT CONTACT, HOWEVER, THERE WAS NO INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299530 ↗
• MalfunctionJan 22, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S EYE AND TEAR WAS NOTICED ON THE LENS. THE SURGEON REMOVED THE LENS AND IMPLANTED ANOTHER. IT WAS STATED THAT THERE WERE NO ADVERSE REACTIONS TO REPORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213351 ↗
• InjuryDec 29, 2020Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) FLIPPED AND HAPTIC BROKE WHEN INSERTING THE LENS INTO THE RIGHT EYE OF A PATIENT. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE IOL. NO PATIENT INJURY WAS REPORTED. THERE WAS NO VITRECTOMY PERFORMED AND NO STITCHES REQUIRED. THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 11091805 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO CAPSULAR BREAK. NO LENS WAS IMPLANTED IN THE PATIENT¿S EYE AS THE DOCTOR IS WAITING FOR THE PATIENT TO HEAL AND WILL IMPLANT AN IOL ON A FUTURE DATE. THE INCISION WAS ENLARGED, SUTURE(S) WERE REQUIRED, AND VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10317997 ↗
• MalfunctionMar 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT A MODEL Z9002 22.0 DIOPTER INTRAOCULAR LENS (IOL) SUDDENLY CAME OUT UPSIDE DOWN INTO THE PATIENT'S LEFT EYE. THE IOL WAS REMOVED. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR ONE OF TWO CARTRIDGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9809269 ↗
• InjuryFeb 28, 2020Adverse 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 IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO VISUAL DISTORTION OF SHAPE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. REPORTEDLY, PATIENT HAS RECOVERED POST-EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9767833 ↗
• InjuryJun 26, 2019Calcified; Calcified

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN 2008 HAS CALCIFIED. THEREFORE, THE DOCTOR EXPLANTED THE IOL. IT WAS STATED THAT THE PATIENT HAS RECOVERED POST-EXPLANT. DESPITE SEVERAL FOLLOW-UPS FOR ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8737653 ↗
• MalfunctionApr 16, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS SCRATCH ON THE LENS NOTICED AFTER INSERTION. REPORTEDLY CARTRIDGE WAS SPLIT ALL THE WAY DOWN CENTER TO END. THERE WAS PATIENT CONTACT. THE LENS WAS REMOVED AND REPLACED IN THE SAME SURGICAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. PATIENT HAD NO PROBLEM AT DISCHARGE. NO FURTHER INFORMATION PROVIDED. THIS REPORT WILL CAPTURE THE LENS. ANOTHER REPORT IS BEING SUBMITTED FOR CARTRIDGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517008 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED IN THE INITIAL SURGERY/PROCEDURE DUE TO AN UNSTABLE CAPSULE BAG. AN UNPLANNED VITRECTOMY ALONG WITH INCISION ENLARGEMENT WAS PERFORMED. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 8431807 ↗