TECNIS CL IOL Z9002 (REF Z900200235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474530768), received between Sep 30, 2016 and Oct 31, 2022 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD BENT HAPTIC. IT IS UNKNOWN IF THE DEVICE HAD PATIENT CONTACT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705248 ↗
• MalfunctionOct 15, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S RIGHT EYE AND WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO A BENT HAPTIC. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612688 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT THE OPTIC OF THE INTRAOCULAR LENS (IOL) CRACKED. THE LENS WAS COMPLETELY INSERTED INTO PATIENT'S LEFT AND WAS REMOVED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO USE ERROR. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080764 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) OPTIC RIPPED COMING OUT OF CARTRIDGE AND THERE WAS PATIENT CONTACT BUT NO INJURY. THE DOCTOR SAID THE PLUNGER WAS IN FRONT OF OPTIC AS HE WAS INSERTING. THE IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935182 ↗
• MalfunctionJan 14, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261415 ↗
• MalfunctionOct 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND ONCE IN THE LEFT EYE, IT WAS REALIZED TO BE TORN. IOL THEN WAS CUT OUT AND REPLACED WITH THE SAME MODEL AND DIOPTER IOL. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE, NO PATIENT POST-OP INJURY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685835 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED AND REMOVED FROM THE PATIENT'S LEFT EYE DURING THE SAME SURGERY DUE TO CAPSULE TEAR. INCISION WAS ENLARGED AND SUTURES WERE DONE. IT WAS INDICATED THAT NO LENS WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12538834 ↗
• MalfunctionSep 20, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS PARTIALLY IMPLANTED INTO PATIENT'S RIGHT EYE WHEN PHYSICIAN NOTED THAT THE HAPTIC WAS BROKEN. THE INCISION WAS ENLARGED AND LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. ACCOUNT VERIFIED THAT THERE WERE NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT WAS REPORTEDLY DOING WELL. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12502918 ↗
• 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 12363142 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE, BUT HAD TO BE CUT OUT DURING THE SAME PROCEDURE BECAUSE THE LENS HAD A CRACK IN IT. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION AND THE PATIENT WAS REPORTED TO BE DOING FINE AFTER SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861365 ↗
• MalfunctionMay 5, 2021Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS OVERRIDDEN BY THE PLUNGER AND THE LENS MAY HAVE BEEN DAMAGED. CARTRIDGE TIP HAD PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775104 ↗
• MalfunctionMay 4, 2021Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE (OD). THERE WAS A TORN LENS. THE LENS WAS ALSO SCRATCHED. IT WAS REMOVED AND REPLACED. THE PROCESS WAS COMPLETED SUCCESSFULLY WITH ANOTHER Z9002 LENS. THE LENS WAS DISCARDED. PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773966 ↗
• MalfunctionApr 8, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC AND IT WAS NOTICED AFTER INSERTION INTO THE PATIENT'S LEFT EYE. THE LENS WAS REPLACED WITH BACKUP LENS OF SAME MODEL AND DIOPTER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING OK POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632728 ↗
• InjuryJul 24, 2020Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A HAPTIC SO BIG THE SURGEON COULD NOT GET IT POSITIONED. THE CAPSULE TORE AND A VITRECTOMY WAS REQUIRED, HOWEVER, IT WAS NOT PRODUCT RELATED. IT WAS ALSO REPORTED THE PATIENT WILL BE RETURNING APHAKIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10318331 ↗
• MalfunctionSep 13, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEBRIS WAS FOUND ON HAPTIC OF INTRAOCULAR LENS. LENS WAS IMPLANTED SUCCESSFULLY AFTER THE DEBRIS WAS REMOVED FROM HAPTIC. PATIENT WAS DOING WELL. THIS REPORT CAPTURES INFORMATION FOR LENS. ANOTHER REPORT IS BEING SUBMITTED FOR CARTRIDGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9041775 ↗
• InjuryJan 31, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THERE WERE NO COMPLICATIONS REPORTED. THE LENS WAS REPLACED WITH THE SAME MODEL, Z9002, 20.5 DIOPTER. THE PATIENT WAS DOING GOOD POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8295462 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF A RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 26.5. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8295149 ↗
• InjuryJan 22, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 23.5 DIOPTER) WAS INSERTED, REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE BECAUSE HAPTIC DID NOT UNFOLD. REPORTEDLY INCISION ENLARGEMENT WAS PERFORMED DURING THE PROCEDURE. ANOTHER LENS WITH SAME MODEL AND SAME DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8265920 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED Z9002 23.5 DIOPTER INTRAOCULAR LENS (IOL) THE HAPTIC WAS BENT AND THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233493 ↗
• InjurySep 7, 2018Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  IT WAS REPORTED THAT SURGEON WAS CONCERNED OF Z9002 MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT CENTER IN THE RIGHT EYE (OD) DUE TO PATIENT'S ANATOMY. THE DOCTOR OPTED TO REMOVE AND REPLACE WITH NON-JNJSV (JOHNSON & JOHNSON SURGICAL VISION) PRODUCT. IT WAS NOTED THAT INCISION ENLARGEMENT WAS PERFORMED TO REMOVE THE LENS. HOWEVER, THERE WAS NO PATIENT INJURY AS THE PATIENT IS DOING FINE POST-SURGERY. PRODUCT IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7856188 ↗
• InjuryOct 9, 2017Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 23.5 DIOPTER INTRAOCULAR LENS (IOL) BROKE OFF WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE LENS WAS REMOVED AND AN INCISION ENLARGEMENT AND VITRECTOMY WERE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6933322 ↗
• InjuryOct 3, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL Z9002, +23.5 DIOPTER) WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) FEMALE PATIENT BECAUSE OF RESIDUAL REFRACTIVE ERRORS. NO INCISION ENLARGEMENT, NO COMPLICATIONS, NO INJURY AND NO ADDITIONAL PROCEDURES WERE REQUIRED. ANOTHER LENS, SAME MODEL HIGHER DIOPTER (+26.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6912513 ↗
• InjurySep 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE IS ONE PATIENT WITH TWO PSEUDOPHAKIC EYES. THE INTRAOCULAR LENSES (IOL'S) WERE IMPLANTED BACK IN 2008. THE PATIENT WAS DIAGNOSED WITH ASTEROID HYALOSIS AND UNDERWENT A YAG PROCEDURE. NOW AN OBSERVATION HAS BEEN MADE THAT THERE ARE DEPOSITS ON BOTH IOL'S (RIGHT AND LEFT EYES). BOTH IOL¿S ARE STILL IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR'S WILL BE FILED, ONE FOR EACH EYE. THIS REPORT CAPTURES THE LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 6859898 ↗
• InjurySep 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE IS ONE PATIENT WITH TWO PSEUDOPHAKIC EYES. THE INTRAOCULAR LENSES (IOL'S) WERE IMPLANTED BACK IN 2008. THE PATIENT WAS DIAGNOSED WITH ASTEROID HYALOSIS AND UNDERWENT A YAG PROCEDURE. NOW AN OBSERVATION HAS BEEN MADE THAT THERE ARE DEPOSITS ON BOTH IOL'S (RIGHT AND LEFT EYES). BOTH IOL¿S ARE STILL IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR'S WILL BE FILED, ONE FOR EACH EYE. THIS REPORT CAPTURES THE RIGHT EYE.

  Patient problems: No Code Available

  MAUDE report 6859875 ↗
• InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A Z9002 23.5 DIOPTER INTRAOCULAR LENS (IOL) THE PATIENT'S CAPSULE BROKE. THE LENS WAS INSERTED AND THE LENS HAD TO BE CUT IN HALF TO BE REMOVED AS THERE WAS NOT ENOUGH ZONULES TO SUPPORT THE LENS. INCISION ENLARGEMENT AND ONE SUTURE WAS REQUIRED. THROUGH FOLLOW-UP IT WAS CLARIFIED THAT THE PATIENT WENT HOME APHAKIC, WITHOUT A LENS BEING IMPLANTED AND WAS REFERRED TO A RETINAL SPECIALIST. THERE WAS NO ISSUE THE AMO CARTRIDGE OR LENS. THE ISSUE WAS WITH THE PATIENT'S ANATOMY. PATIENTS HAD WEAK ZONULES AND AS A RESULT THE CAPSULE BROKE.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6183465 ↗