TECNIS CL IOL Z9002 (REF Z900200195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474530683), received between Mar 13, 2017 and Mar 8, 2024 — classified as 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE AS THE LENS HAD CALCIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867215 ↗
• InjuryJan 28, 2022Adverse 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 A PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER (17.5) WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 13389364 ↗
• MalfunctionJan 20, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S RIGHT EYE, HOWEVER, IT WAS REMOVED AS THE HAPTIC CAME OFF WHEN THE SURGEON TRIED TO STRAIGHTEN THE LENS INSIDE THE EYE. THE INCISION WAS ENLARGED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. PATIENT WAS REPORTEDLY FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311249 ↗
• 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 12729046 ↗
• MalfunctionOct 14, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635514 ↗
• MalfunctionSep 21, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511024 ↗
• 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. IT WAS STATED THAT THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354642 ↗
• MalfunctionJul 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SURGEON OBSERVED THAT THE INTRAOCULAR LENS (IOL) WAS TORN WHEN HE INSERTED THE LENS INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED FROM THE EYE AND A NEW LENS WAS INSERTED WITHOUT ANY FURTHER COMPLICATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221412 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Mechanical Jam; Break; Inaccurate Delivery; Mechanical Jam

  CUSTOMER REPORTED THAT UPON INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE THE LENS TORE, WHILE USING THE PLUNGER. THERE WAS PATIENT CONTACT WITH THE PRODUCT. CUSTOMER INDICATED THAT IT COULD BE A FAULTY PLUNGER. THE IOL WAS TAKEN OUT WITH NO TROUBLE, AND A NEW LENS WAS INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170911 ↗
• MalfunctionJun 11, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD DAMAGED HAPTICS AS THE PLUNGER OVERRODE THE LENS. THE LENS WAS INSERTED IN THE RIGHT EYE AND REMOVED DURING THE SAME-PROCEDURE. THERE WAS NO INCISION ENLARGEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987401 ↗
• MalfunctionJun 10, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS INSERTED IN TO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND THE PLUNGER OVERRODE THE LENS DAMAGING THE HAPTICS. THE LENS WAS REMOVED AND THERE WAS NO INCISION ENLARGEMENT. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980085 ↗
• MalfunctionMay 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS TORN. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823520 ↗
• InjuryApr 22, 2020Calcified; Material Discolored; Calcified; Material Discolored

  IT WAS REPORTED THAT SOMETHING LIKE A CLOUD DEVELOPED ON THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE OF A MALE PATIENT. IT WAS INDICATED THAT THE PATIENT WAS TREATED WITH YAG (YTTRIUM-ALUMINUM-GARNET) LASER PROCEDURE, BUT THE SYMPTOMS ARE PERSISTENT. IT WAS CONFIRMED THAT THE REPORTED ISSUE DID NOT CAUSE VISUAL IMPAIRMENT IN THE PATIENT AND NO PATIENT INJURY WAS REPORTED. ADDITIONALLY, THE DOCTOR EXPLAINED THAT THE ENTIRE SURFACE OF THE LENS BECOMES WHITE AND CLOUDY WITH THE Z9002 WHICH HE REPORTED THE ISSUE ON IT. THE DOCTOR THINKS THE ISSUE IS POSSIBLY CALCIFICATION BUT HE IS NOT SURE OF THE CAUSE. THE DOCTOR WILL MAKE THE DECISION IN (B)(6) 2020 AS TO WHETHER OR NOT THE LENS NEEDS TO BE EXTRACTED FROM THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9984636 ↗
• InjuryMar 11, 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 EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO RESIDUAL REFRACTIVE ERROR. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO COMPLICATIONS, INJURY, OR ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED. REPORTEDLY, PATIENT IS DOING FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9815123 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED Z9002 19.5 DIOPTER INTRAOCULAR LENS (IOL) THE HAPTIC WAS BENT AND KINKED IN THE CARTRIDGE. NEW DESIGN HAS A WIDER THREAD AND ADVANCES TOO QUICKLY CAUSING IT TO ROTATE AND KINK THE HAPTIC IN THE CARTRIDGE. THERE IS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8892873 ↗
• InjuryApr 26, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +19.5 DIOPTER) HAD MISSING TRAILING HAPTIC WHICH WAS OBSERVED WHILE DEPLOYING THE LENS INTO PATIENT¿S OPERATIVE EYE. REPORTEDLY INCISION ENLARGEMENT WAS PERFORMED DURING THIS PROCEDURE. PATIENT WAS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8558464 ↗
• MalfunctionMar 10, 2019Break; Break

  IT WAS REPORTED THAT A Z9002 19.5 DIOPTER MONOFOCAL LENS HAPTIC BROKE DURING ADVANCEMENT INTO THE EYE. REPORTEDLY THERE WERE NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406433 ↗
• MalfunctionJan 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 19.5 DIOPTER INTRAOCULAR LENS WAS NOTICED BENT WHEN REMOVING FROM PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8215738 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNEXPECTED POST-OP REFRACTION AFTER THE IMPLANTATION OF MODEL Z9002 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) IN THE RIGHT EYE (OD). LENS WAS EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON LENS. THERE WAS NO COMPLICATION, NO PATIENT INJURY AND PATIENT IS DOING FINE POST OP. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8215728 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS DAMAGED WHILE INSERTING THE LENS INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE HAPTIC WAS BENT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY REPORTED. PATIENT WAS DISCHARGED STABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103552 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A Z9002 19.5 DIOPTER INTRAOCULAR LENS (IOL) RIPPED THE CAPSULAR BAG WHEN INSERTING INTO THE PATIENT'S RIGHT EYE (OD). VITRECTOMY WAS PERFORMED, AND NO INJURY WAS REPORTED. PATIENT VISUAL ACUITY POST-OPERATIVE IS 20/50. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8003393 ↗
• MalfunctionOct 20, 2018Break; Break

  IT WAS REPORTED INITIALLY THAT THERE WAS A LOADING ERROR WITH THE PRELOADED INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THE HAPTIC WAS CRIMPED/BENT AND THE PHYSICIAN WAS ABLE TO REMOVE THE IOL AND CARTRIDGE FROM THE EYE BEFORE FULLY IMPLANTING THE LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. NO PATIENT INJURY. THE PATIENT IS REPORTED TO BE FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988303 ↗
• MalfunctionApr 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL Z9002) WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE BECAUSE DEBRIS WAS OBSERVED ON THE LENS. THE ACCOUNT COMMENTED THAT THE SURFACE OF THE LENS SEEMED MORE SLIPPERY. NO INCISION ENLARGEMENT AND NO PATIENT INJURY WAS REPORTED. ANOTHER LENS, SAME MODEL, WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, SUTURES WERE USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7445371 ↗
• InjuryDec 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 FOR REASONS STILL UNKNOWN. THERE WAS NO INCISION ENLARGEMENT PERFORMED OR SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT THE DIOPTER WAS NOT PROVIDED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7102999 ↗
• InjuryJun 19, 2017Adverse 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. THE DOCTOR CHANGED TO ANTERIOR CHAMBER (AC) IOL. POSSIBLE VITRECTOMY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6649431 ↗