TECNIS CL IOL Z9002 (REF Z900200190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05050474530676), received between Dec 12, 2016 and Feb 7, 2022 — classified as 14 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC BROKE AND THERE WAS CONTACT WITH THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE COMPLETED SUCCESSFULLY USING BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476961 ↗
• MalfunctionJul 23, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS BROKE INSIDE PATIENT'S EYE DURING IMPLANTATION. THE LENS WAS REMOVED COMPLETELY ALONG WITH ALL THE BROKEN PIECES AND A NEW LENS WAS PLACED INSIDE THE OPERATIVE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222119 ↗
• MalfunctionApr 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BACK HAPTIC OF THE INTRAOCULAR LENS (IOL) TORE OFF DURING INSERTION. THE SURGEON REMOVED THE LENS AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER WHICH WENT FINE. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11660290 ↗
• MalfunctionMar 10, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED A SCRATCH UPON THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION INTO PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449755 ↗
• InjuryDec 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS LOOSE AFTER INSERTION INTO THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND A VITRECTOMY WAS PERFORMED. A NON-JNJ ANTERIOR CHAMBER IOL WAS USED AS A REPLACEMENT LENS. THERE WAS NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 11099582 ↗
• InjuryDec 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO LENS DISLOCATION. IT WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL BUT SAME DIOPTER POWER. A VITRECTOMY WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 11099305 ↗
• InjuryNov 6, 2020Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO DEBRIS/PARTICLES ON LENS, IOL DEPOSITS, INITIAL IMPLANT 2011. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10799073 ↗
• 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 LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO RESIDUAL REFRACTIVE ERROR. NO COMPLICATIONS, INJURY, OR ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THE CUSTOMER ALSO INDICATED THAT THE LENS HAD BEEN DISCARDED. REPORTEDLY, PATIENT HAS RECOVERED FROM THE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9826966 ↗
• InjuryDec 16, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS RIPPED NOTICED AFTER IT WAS IMPLANTED. IT WAS THEN REMOVED AND REPLACED WITH THE BACK-UP LENS, BUT INCISION WAS ENLARGED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9474250 ↗
• 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 9463585 ↗
• InjuryNov 21, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT HAD MILKY WHITE LENSES IN BOTH OPERATIVE EYES. THERE WERE NO LASER MARKS. ON (B)(6) 2008 PATIENT HAD TECNIS LENS IMPLANTED IN RIGHT (OD) EYE AND ON (B)(6 )2008 HAD TECNIS LENS IMPLANTED IN LEFT (OS) EYE. LAST EYE EXAM WAS PERFORMED 2 YEARS AGO, AND PHYSICIAN SAID NOTHING HAD CHANGED AT THAT TIME. YAG CAPSULOTOMY WAS PERFORMED ON BOTH EYES. PATIENT OUTCOME WAS REPORTED AS 20/50 (RIGHT EYE) 20/200(LEFT EYE). THIS REPORT WILL CAPTURE THE EVENT FOR THE PATIENT¿S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 9351938 ↗
• MalfunctionSep 11, 2019Break; Calcified; Break; Calcified

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, THE Z9002 INTRAOCULAR LENS (IOL) LOOKED DISTORTED AND CLOUDY. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 8987955 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAS BEEN FEELING DIZZY AFTER IMPLANT OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE PATIENT ALSO REPORTED SEEING FLOATERS AND AFTER WEARING EYE GLASSES HE COMPLAINS OF HEADACHES. THE PATIENT INDICATED THAT HE CANNOT READ FOR MORE THAN 20-30 MINUTES AT A TIME BECAUSE OF THE HEADACHES, THEREFORE, HE HAS A DIFFICULT TIME FOCUSING. HIS VISION AT NIGHT IS NOT AS CLEAR, SO HE IS NOT COMFORTABLE DRIVING AT NIGHT. THE PATIENT HAD A PRK (PHOTOREFRACTIVE KERATECTOMY) PERFORMED ON (B)(6) 2019, AND IS STILL IN THE HEALING PROCESS. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT REPRESENT THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

  Patient problems: Dizziness; Headache; Visual Disturbances

  MAUDE report 8620689 ↗
• MalfunctionFeb 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS TEAR IN THE INTRAOCULAR LENS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS OBSERVED WHEN REMOVING FROM PACKAGING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8352906 ↗
• MalfunctionFeb 15, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE Z9002 INTRAOCULAR LENS (IOL) WAS OBSERVED BENT WHEN THE LENS CASE WAS OPENED. REPORTEDLY, THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8342542 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) 19.0 DIOPTER WAS IMPLANTED IN A PATIENT WHO DEVELOPED UNEXPECTED REFRACTIVE RESULT. THEREFORE, THE IOL WAS EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES PERFORMED. REPLACEMENT IOL WAS Z9002, 21.5 DIOPTER. IT WAS STATED THAT THE PATIENT WAS DOING WELL AFTER DISCHARGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8206250 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT WHEN A Z9002 INTRAOCULAR LENS WAS RECEIVED, THE PRODUCT HAD A DAMAGED HAPTIC. IT WAS BROKEN WHEN RECEIVED BUT THE BOXES WHERE NOT DAMAGED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 8177079 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT WHEN TECH PULLED LENS OUT OF STERILE PACKAGE; THE INTRAOCULAR LENS HAD A BENT HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8172234 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT A Z9002 19.0 DIOPTER INTRAOCULAR LENS (IOL), HAD THE HAPTIC BENT PRIOR TO LOADING. FOLLOW-UP CONFIRMED THAT THE EVENT OCCURRED WHEN THEY OPENED THE PACKAGE, THEY TOOK OUT THE LENS AND THEY NOTICED THAT ONE OF THE BLUE HAPTICS WAS BENT. THEY DID NOT WANT TO USE THIS. HENCE, THEY USED THE BACK-UP LENS AND IT WAS GOOD. SURGERY WENT WELL AFTERWARDS. NO PATIENT CONTACT ON THE SUSPECT LENS.

  Patient problems: No Patient Involvement

  MAUDE report 8113446 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD DISTORTED HAPTIC. REPORTEDLY PROBLEM WAS NOT RELATED TO USER ERROR. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8088108 ↗
• InjuryOct 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +19.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE OF THE PATIENT EXPERIENCING AN HYPEROPIC OUTCOME. DURING THE PROCEDURE AN INCISION ENLARGEMENT WAS PERFORMED. REPORTEDLY, THE LENS WAS REPLACED WITH THE SAME MODEL, A Z9002 +24.5 DIOPTER. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7933875 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 19.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) 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 THE 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. THE PATIENT WAS TOLD TO USE EYE DROPS BY THE IMPLANTING DOCTOR. PATIENT REPORTED 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 LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Nausea; Visual Impairment

  MAUDE report 7661385 ↗
• InjuryApr 2, 2018Bent; Positioning Problem; Bent; Positioning Problem

  IT WAS REPORTED THAT A Z9002 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED BECAUSE A SLIGHT DISTORTION OR KINK WAS NOTICED ON THE HAPTIC AND THE LENS WOULD NOT CENTER PROPERLY. THE REPLACEMENT LENS WAS A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7388750 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. SINCE THEN, SHE HAS BEEN EXPERIENCING DOUBLE VISION WHICH IS IMPACTING HER LIFE TREMENDOUSLY. THE DOUBLE VISION STARTED THE DAY OF THE SURGERY, BUT ONLY TO THE BOTTOM PART OF THE LENS. THERE ARE NO ISSUES WITH THE TOP PART. FURTHERMORE, STARTING ABOUT ONE MONTH POST-OPERATIVELY, WHEN THE PATIENT GOES FROM A BRIGHT ROOM TO A DIMMER ROOM, HER VISION BECOMES TOTALLY DARK AND ADJUSTS GRADUALLY AFTER A FEW MINUTES AS IF WEARING TRANSITION LENSES. THE PATIENT HAS REPORTEDLY INFORMED HER EYE CARE PROFESSIONAL REGARDING THIS MATTER, ONLY TO HAVE BEEN TOLD THAT THERE WAS NOTHING THEY COULD DO ABOUT IT. THE PATIENT HAS ALSO SEEN SOME SPECIALISTS AND WAS TOLD THAT HER PROBLEMS MAY STEM FROM THE ANESTHESIA USED DURING HER SURGERY. IT WAS RECOMMENDED THAT THE PATIENT HAVE SURGERY IN HER RIGHT EYE TO SHORTEN THE MUSCLE IN THAT EYE BECAUSE THEY CAN'T REPAIR THE DAMAGE DONE THE TO LEFT EYE. THE PATIENT''S CURRENT VISION IS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7329358 ↗
• MalfunctionJun 16, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE, THE DOCTOR NOTICED A SCRATCH IN THE CENTER OF THE IOL. THE IOL WAS CUT AND REMOVED FROM THE EYE AND ANOTHER IOL WAS SELECTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6649160 ↗