TECNIS CL IOL Z9002 (REF Z900200210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05050474530713), received between Sep 8, 2016 and Sep 23, 2026 — classified as 20 injuries, 25 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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Opacification

  Patient problems: Visual Disturbances

  MAUDE report 50876188 ↗
• InjuryAug 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING BLURRY VISION AND A FILM OVER THE LEFT EYE (OS). THE PATIENT WAS DIAGNOSED WITH A SUBLUXED LENS, AND AN INITIAL ATTEMPT TO PERFORM INTRASCLERAL HAPTIC FIXATION (ISHF) USING A Z9002 LENS WAS UNSUCCESSFUL. ADDITIONAL INFORMATION PROVIDED ON JULY 28, 2025, INDICATED THAT THE SURGEON SUBSEQUENTLY COMPLETED THE ISHF (INTRASCLERAL HAPTIC FIXATION) PROCEDURE USING AN LI61AO LENS. THE FILM OVER THE LEFT EYE WAS DETERMINED TO BE UNRELATED TO POSTERIOR CAPSULAR OPACIFICATION, AS THE PATIENT HAD PREVIOUSLY UNDERGONE YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY ON (B)(6) 2021. POSTOPERATIVELY, THE PATIENT REPORTED IMPROVED VISION AS EARLY AS THE FIRST DAY FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22768177 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTED TO BE DAMAGED WHEN PUT IN EYE, HAD TO BE CUT OUT. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE, NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849324 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BENT. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566201 ↗
• MalfunctionSep 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TORN AND HENCE REMOVED AND REPLACED DURING THE SAME PROCEDURE. THERE WAS A PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488616 ↗
• MalfunctionJul 22, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL Z9002, APPEARED TO HAVE A DEFECT AFTER IMPLANTATION. THE PHYSICIAN REMOVED THE LENS FROM THE PATIENT'S EYE AND DISCARDED THE LENS. ANOTHER JOHNSON AND JOHNSON LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215459 ↗
• MalfunctionJun 11, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A SCRATCH ON IT DISCOVERED AFTER INJECTING. THIS LENS DID TOUCH THE PATIENT. A NEW ONE WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987682 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) HAD BROKEN HAPTIC. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822885 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS(IOL) HAD BROKEN HAPTIC. THERE WAS PATIENT CONTACT AND THE LENS WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606826 ↗
• MalfunctionMar 4, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) HAD A LOADING ERROR, THE LENS WAS DAMAGED DURING LOAD AND DOCTOR WANTED A NEW LENS. THERE WAS CONTACT WITH CARTRIDGE TIP AND HAPTIC/OPTIC WITH EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408861 ↗
• MalfunctionMar 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS TORN. THE LENS WAS INSERTED, HOWEVER, REMOVED AND REPLACED IN THE SAME PROCEDURE USING ANOTHER LENS OF SAME MODEL. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING GOOD POST-OP. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398371 ↗
• InjuryFeb 4, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT BILATERAL Z9002 INTRAOCULAR LENS (IOL) WERE IMPLANTED IN THE PATIENT'S EYE AND DEVELOPED RETICULAR POSTERIOR CAPSULAR OPACIFICATION (PCO). YTTRIUM-ALUMINUM GARNET (YAG) LASER TREATMENT WAS PERFORMED AND WAS INDICATED THAT THE DEPOSITS DID NOT COME OFF. THROUGH ADDITIONAL INFORMATION IT WAS INDICATED THAT 7 YEARS AFTER BILATERAL IMPLANTATION, PATIENT DEVELOPED RETICULAR IOL DEPOSITS. THERE WERE SEVERAL YAG PROCEDURES FROM 2015 TO RECENT AS (B)(6) 2021. THERE HAS NOT BEEN ANY INJURIES, JUST DECREASED BEST CORRECTED ACUITY. THE PCO HAS DECREASED ACTIVITIES OF DAILY LIVING. THIS MDR REPORT IS TO CAPTURE THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

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

  MAUDE report 11283115 ↗
• InjuryFeb 4, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT BILATERAL Z9002 INTRAOCULAR LENS (IOL) WERE IMPLANTED IN THE PATIENT'S EYE AND DEVELOPED RETICULAR POSTERIOR CAPSULAR OPACIFICATION (PCO). YTTRIUM-ALUMINUM GARNET (YAG) LASER TREATMENT WAS PERFORMED AND WAS INDICATED THAT THE DEPOSITS DID NOT COME OFF. THROUGH ADDITIONAL INFORMATION IT WAS INDICATED THAT 7 YEARS AFTER BILATERAL IMPLANTATION, PATIENT DEVELOPED RETICULAR IOL DEPOSITS. THERE WERE SEVERAL YAG PROCEDURES FROM 2015 TO RECENT AS (B)(6) 2021. THERE HAS NOT BEEN ANY INJURIES, JUST DECREASED BEST CORRECTED ACUITY. THE PCO HAS DECREASED ACTIVITIES OF DAILY LIVING. THIS MDR REPORT IS TO CAPTURE THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

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

  MAUDE report 11282942 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE PATIENT WAS UNHAPPY WITH RESIDUAL REFRACTIVE ERROR. SYMPTOMS WERE NOTED APPROXIMATELY TWO WEEKS POST-IMPLANT. AT EXPLANT/EXCHANGE THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION LENS. THE PATIENT WAS REPORTED TO BE DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10681914 ↗
• InjuryMar 12, 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 LEFT (OS) 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 9827260 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED Z9002 21.0 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS CUT OUT OF THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND AN ANTERIOR CHAMBER LENS PLACED INSTEAD. THROUGH FOLLOW UP, CUSTOMER ACCOUNT CONFIRMED NO IOL PRODUCT QUALITY ISSUE, NO SERIOUS PATIENT INJURY, AND NO SUTURE(S) HOWEVER, THE INCISION WAS ENLARGED, AND VITRECTOMY WAS PERFORMED. IT WAS REPORTED THE SAME PROCEDURE COMPLETED SUCCESSFULLY USING BACKUP LENS WITH DIFFERENT MODEL AND/OR DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9409499 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL), WHICH WAS IMPLANTED INTO THE PATIENT LEFT EYE, WAS EXPLANTED AND EXCHANGED FOR ANOTHER IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER DUE TO A REFRACTIVE ERROR AND BLURRY VISION. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9122648 ↗
• InjuryJul 31, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A Z9002 21.0 DIOPTER LENS WAS EXPLANTED DUE TO THE LENS DISLOCATED INSIDE THE LEFT EYE AND HAD A DAMAGED HAPTIC. INITIALLY THE DOCTOR PLANNED ON REPOSITIONING THE LENS BUT ONCE IN THE EYE HE NOTED THAT THE HAPTIC WAS BENT SO HE DECIDED TO EXPLANT THE LENS AND REPLACE IT WITH THE SAME MODEL Z9002 AND DIOPTER. VIA FOLLOW-UP, THE CUSTOMER EXPLAINED THAT THE INCISION WAS ENLARGED AND SUTURES WERE USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8845040 ↗
• InjuryApr 10, 2019Crack; Crack

  IT WAS REPORTED THAT A Z9002 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS TORN UPON INSERTION INTO THE PATIENT'S LEFT EYE, AND HAD TO BE REMOVED. INCISION WAS ENLARGED AND VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8502014 ↗
• MalfunctionMar 26, 2019Break; Break

  RECEIVED A BOX WITH THE ONLY INFORMATION INDICATED IS BROKEN HAPTIC. DESPITE FOLLOW-UP, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8453800 ↗
• InjuryMar 16, 2019Contamination; Contamination

  IT WAS REPORTED THAT PATIENT HAD A DIFFICULTY SEEING IN HER RIGHT EYE DUE TO FOREIGN MATERIAL OR DEBRIS ON THE REAR SURFACE OF IMPLANTED LENS MODEL, Z9002 MONOFOCAL IOL (INTRAOCULAR LENS). THE DOCTOR ATTEMPTED TO PEEL THIS DEBRIS OFF BY USING YAG (YTTRIUM-ALUMINUM-GARNET) LASER ON (B)(6) 2018, BUT IT WAS REPORTEDLY IMPOSSIBLE. AS A RESULT, LENS WAS EXPLANTED AND REPLACED INSTEAD. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8427193 ↗
• MalfunctionMar 5, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A Z9002 21.0 DIOPTER INTRAOCULAR LENS (IOL) HAPTIC WAS DISTORTED WHEN INSERTING INTO THE PATIENT'S EYE. THERE IS NO INDICATION THAT SURGICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8389090 ↗
• MalfunctionFeb 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS CRACKED. THERE WAS PATIENT INVOLVEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES WERE REQUIRED. THIS WAS OBSERVED WHILE INSERTING THE LENS INTO THE EYE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS WAS FULLY INSERTED, REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE WITHOUT ANY PATIENT INJURY. REPORTEDLY LENS WITH SAME MODEL AND DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING GREAT AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368723 ↗
• InjuryJan 15, 2019Pitted; Contamination /Decontamination Problem; Pitted; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A Z9002, 21.0 DIOPTER INTRAOCULAR LENS (IOL) HAS PITTING ON THE BACK-SURFACE POST IMPLANTATION. YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS DONE THINKING IT WAS POSTERIOR CAPSULE, BUT IT WAS NOT. PER INFORMATION ON THE RECEIVED COMPLAINT FORM, THE LENS REMAINS IMPLANTED. PROBLEM OBSERVED ON (B)(6) 2018. LENS HAS APPEARANCE OF A SECONDARY CATARACT, BUT AFTER CAPSULOTOMY WAS PERFORMED, DEBRIS/PITTING WAS STILL PRESENT, OD (RIGHT EYE). PATIENT NOTED TO HAVE HAZINESS OF VISION FOR SOME TIME. APPEARANCE OF POSTERIOR CAPSULE OPACITY, YET HAZINESS ON POSTERIOR ASPECT OF LENS REMAINED IN SPITE OF OPENING POSTERIOR CAPSULE. NO SECONDARY SURGICAL PROCEDURE REQUIRED. NO PLAN TO EXPLANT. VISUAL ACUITY (VA) PRE-OP, 20/30; VA POST-OP, 20/30. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 8251612 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 21.0 DIOPTER LENS BECAME CROOKED WHILE INSERTING INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY, THIS WAS DUE TO A TECHNICIAN/USE ERROR. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171190 ↗