TECNIS CL IOL Z9002 (REF Z900200180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474530652), received between Nov 8, 2016 and Mar 27, 2023 — classified as 12 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Break; Break

  RECEIVED REPORT INDICATING THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16621574 ↗
• MalfunctionJun 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LEAD HAPTIC OF THE INTRAOCULAR LENS (IOL) DETACHED. THERE WAS NO DAMAGE TO THE LENS PRIOR TO LOADING INTO THE CARTRIDGE. ONLY THE CARTRIDGE TIP MADE CONTACT WITH PATIENT'S LEFT EYE. THERE WAS NO DELAY IN SURGERY REPORTED AND NO OTHER INTERVENTION REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE ACCOUNT USED OPHTHALMIC VISCOELASTIC DEVICE (OVD) AND THE OVD WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM TEMPERATURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751240 ↗
• MalfunctionMar 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS OBSERVED TO BE CUT IN HALF. THE SURGEON CUT THE LENS OUT AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653136 ↗
• MalfunctionJan 27, 2022Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377891 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE DURING THE SAME PROCEDURE AS THE HAPTIC WAS BENT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS FINE POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374466 ↗
• MalfunctionSep 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED WHILE INSERTING THE INTRAOCULAR LENS (IOL) THERE WAS DEBRIS ON THE LENS AND THE CARTRIDGE HAD CONTACT WITH THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447459 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. THE EVENT WAS OBSERVED WHEN INSERTING THE IOL INTO THE EYE; THEREFORE, THE LENS WAS PARTIALLY INSERTED. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169882 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE AND HAD TO BE REMOVED AND REPLACED DUE TO A BENT HAPTIC. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458287 ↗
• MalfunctionFeb 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED WHEN THE SURGEON NOTICED THE LENS WAS TORN. LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. A REPLACEMENT LENS IS OF THE SAME MODEL AND DIOPTER, SERIAL NUMBER (B)(4). THERE IS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287845 ↗
• MalfunctionFeb 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS TORN. THERE WAS PATIENT CONTACT WITH FRONT HAPTIC, REMOVED AND REPLACED WITH BACK-UP LENS. EVENT WAS OBSERVED WHEN INSERTING. THERE WAS NO PATIENT INJURY AND NO SURGICAL OR MEDICAL INTERVENTIONS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267788 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 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 RESIDUAL REFRACTIVE ERROR. NO COMPLICATIONS, INJURY, OR ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT HAS RECOVERED FROM THE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9826696 ↗
• MalfunctionJul 10, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS SOME TYPE OF DEBRIS/PARTICLE ON A INTRAOCULAR LENS (IOL) PRIOR TO LOADING. THERE WAS NO PATIENT CONTACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8774464 ↗
• InjuryMay 23, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +18.0 DIOPTER) WAS IMPLANTED AND REMOVED IN SAME SURGICAL PROCEDURE BECAUSE OF LENS SLIDING BACK TO THE POSTERIOR EYE. THE LENS WAS CONTAMINATED AND DISCARDED PER CUSTOMER. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT DURING THE REMOVAL PROCEDURE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. REPORTEDLY PATIENT WAS DOING OK AND IS BEING TREATED FOR INCREASED INTRAOCULAR PRESSURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8634885 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS Z9002 18.0 DIOPTER INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT BUT WAS NOT INSERTED BECAUSE A VITRECTOMY WAS REQUIRED ON THE PATIENT'S OPERATIVE EYE. THE PATIENT IS DOING FINE POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8340289 ↗
• MalfunctionJan 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A Z9002 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED BENT WHEN REMOVING FROM THE PACKAGING. THERE WAS NO PATIENT CONTACT AND THE PRODUCT WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8238387 ↗
• MalfunctionDec 27, 2018Separation Problem; Separation Problem

  IT WAS REPORTED WHEN OPENING Z9002 18.0 DIOPTER INTRAOCULAR LENS (IOL) THE LENS HAPTIC WAS STUCK IN PLASTIC TURN AND BROKE OFF. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8198388 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED THAT HER VISION WAS VERY BAD, SHE COULD NOT SEE VERY WELL, AND EXPERIENCED BLURRY VISION AND NAUSEA. SHE ALSO COMMENTED/THOUGHT THAT SHE DIDN'T NEED THE LENS IMPLANTS. THE OUTCOMES HAVE SIGNIFICANTLY AFFECTED THE PATIENT'S ACTIVITIES OF DAILY LIFE. THERE WAS NO PATIENT INJURY. REPORTEDLY, THE PATIENT HAS SEEN MULTIPLE DOCTORS ABOUT THESE ISSUES AND WAS TOLD THAT NOTHING IS WRONG AND IT'S JUST DRY EYES. PLUGS WERE PLACED IN BOTH OF THE PATIENT'S EYES AS INTERVENTION BY ANOTHER DOCTOR TO ADDRESS DRY EYE, WHICH PATIENT STATED DID NOT HELP. ALSO, THE PATIENT WAS TOLD TO USE EYE DROPS BY THE IMPLANTING DOCTOR. PATIENT REPORTS THE DROPS HAVE NOT HELPED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Nausea; Visual Impairment

  MAUDE report 7661390 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +18.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT. REPORTEDLY, THE PATIENT REQUESTED A MULTIFOCAL LENS AND THEREFORE THE LENS MODEL ZLB00 18.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7644811 ↗
• InjuryJun 28, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +18.0 DIOPTER) WAS IMPLANTED AND THEN THE SURGEON REALIZED THAT THE POSTERIOR CAPSULE WOULD NOT SUPPORT THE LENS HENCE IT WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER LENS (NON-JOHNSON&JOHNSON LENS). BOTH THE HAPTICS WERE DETACHED DURING THE REMOVAL PROCESS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DURING THE REMOVAL OF THE LENS, THE INCISION WAS ENLARGED. NO CAPSULE TEAR AND NO OTHER MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7644797 ↗
• InjuryJun 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 18.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF A HYPEROPIC OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7624522 ↗
• InjuryJun 1, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +18.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF THE PATIENT EXPERIENCING RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH ANOTHER Z9002 IOL BUT A LOWER DIOPTER (+14.5). PATIENT REPORTED AS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7559439 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO RESIDUAL REFRACTIVE ERROR/UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. THE REPLACEMENT LENS WAS A LENS MADE BY A DIFFERENT MANUFACTURER. THERE WERE ALSO NO COMPLICATIONS AND THE PATIENT HAS RECOVERED. THE EXPLANTED LENS IS NOTED TO BE LOST/DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7343459 ↗
• InjuryMay 5, 2017Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL Z9002 +18.0 DIOPTER, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A PATIENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. THE LENS WAS REPLACED WITH A TORIC LENS, MODEL ZCT150 SAME DIOPTER (+18.0). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6546649 ↗
• MalfunctionMar 31, 2017Crack; Crack

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE PLUNGER OF THE INJECTOR OVERRODE THE LENS AND AS A RESULT THE LENS WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450711 ↗
• MalfunctionMar 2, 2017Break; Device Damaged Prior to Use; Scratched Material; Break; Device Damaged Prior to Use; Scratched Material

  IT WAS REPORTED THAT THE Z9002 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DEFECTIVE OUT OF THE BOX. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6371105 ↗