TECNIS CL IOL Z9002 (REF Z900200225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05050474530744), received between Sep 16, 2016 and Apr 6, 2022 — classified as 9 injuries, 23 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn

  RECEIVED REPORT FROM HEALTH CARE PROVIDED (HCP) INDICATING THE INTRAOCULAR LENS (IOL) TORE WHEN THE SURGEON PUSHED IT THROUGH THE INJECTOR. THE CUSTOMER EXPLAINED THAT BOTH THE IOL AND THE CARTRIDGE TOUCHED THE EYE. THERE WAS NO CAPSULE TEAR, NO VITRECTOMY OR SUTURES NEEDED. AND NO MEDICATION OUTSIDE THE REGULAR STANDARD OF CARE. THE IOL PARTIALLY WENT INTO THE PATIENT¿S EYE. THE DOCTOR THEN REMOVED THE CARTRIDGE AND IOL. A NEW CARTRIDGE AND IOL WERE GIVEN TO THE SCRUB NURSE. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS WITHOUT ANY COMPLICATIONS. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027328 ↗
• MalfunctionMar 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE LENS TORE UPON INSERTION. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13782387 ↗
• MalfunctionJan 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) RIPPED WHEN TRYING TO POSITION IT ONCE IT WAS IMPLANTED INTO PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. THE PRODUCT HAS BEEN DISCARDED. NO OTHER INTERVENTIONS WERE NEEDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173312 ↗
• MalfunctionDec 8, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  DOCTOR REPORTED THAT UPON INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, HE NOTICED THE IOL WAS CRACKED. NOT TORN ALL THE WAY BUT CRACKED. THE IOL WAS PARTIALLY INSERTED, SO IT HAD PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS. NO COMPLICATIONS REPORTED SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965385 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT LENS WAS DAMAGED IN THE CARTRIDGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777015 ↗
• MalfunctionSep 29, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS CUT IN HALF AND REMOVED FROM THE PATIENT'S OPERATIVE EYE BECAUSE THE SURGEON NOTICED WHAT LOOKED LIKE POCK MARKS ON CENTER OF IOL. THE LENS WAS THEN CUT IN HALF AND REMOVED FROM PATIENTS EYE. A NEW LENS WAS THEN INSERTED DURING THE SAME PROCEDURE. NO COMPLICATIONS OR ADDITIONAL SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12549957 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) SHEARED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538286 ↗
• InjuryJul 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING GLARE AND LIGHT DISTORTION SINCE THE IMPLANT OF THE INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE LENS WAS DECENTERED AND WAS EXPLANTED FROM THE PATIENT'S EYE. A SMALL VITRECTOMY WAS PERFORMED AND A COMPETITOR LENS WAS IMPLANTED INTO SULCUS. THE PATIENT WAS DISCHARGED HOME. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 12230079 ↗
• MalfunctionJul 15, 2021Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SURGEON NOTICED A TEAR IN THE INTRAOCULAR LENS (IOL) WHEN IT WAS PARTIALLY INSERTED INTO PATIENT'S EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT AND PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178566 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT¿S RIGHT EYE. THE IOL WAS REMOVED AND REPLACED WITH A BACK UP LENS DURING THE INITIAL PROCEDURE DUE TO A BENT/BROKEN HAPTIC. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170249 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT A Z9002 LENS WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE AND WAS NOTICED THAT THE LENS WAS CRACKED IN HALF. LENS WAS CUT OUT OF THE EYE BUT NO VITRECTOMY OR SUTURES WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148025 ↗
• MalfunctionJul 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS TORN. THE EVENT WAS OBSERVED AFTER INSERTION INTO THE PATIENT'S RIGHT EYE AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER ((B)(4)) DURING THE SAME PROCEDURE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125728 ↗
• MalfunctionJun 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, REMOVED AND REPLACED WITH A SAME MODEL AND DIOPTER LENS, DURING THE SAME PROCEDURE FROM THE PATIENT'S LEFT EYE DUE TO IOL TORN. IT WAS STATED THAT THE PATIENT HAS RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935626 ↗
• MalfunctionFeb 11, 2021Material Fragmentation; Difficult to Advance; Material Fragmentation; Difficult to Advance

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS DETACHED. THE LENS WAS PARTIALLY INSERTED INTO PATIENT EYE AND WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS OF SAME MODEL. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312409 ↗
• InjuryApr 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT AFTER THE IMPLEMENTATION OF A Z9002 INTRAOCULAR LENS (IOL) IN HER RIGHT (OD) EYE ON (B)(6) 2020, SHE IS EXPERIENCING STINGING, ITCHING AND BURNING IN HER EYE, THAT BEGAN AFTER DISCONTINUING MEDICATED EYEDROPS PRESCRIBED BY HER DOCTOR AFTER THE SURGERY. THE IRRITATION IS CAUSING HER EYES TO WATER EXCESSIVELY. SHE DESCRIBED IT LIKE BEING PEPPER SPRAYED. IN ADDITION, THE IRRITATION HAS WOKEN HER UP IN THE NIGHT. THESE EPISODES LAST ABOUT 1-2 MINUTES, BUT DON¿T OCCUR EVERY DAY. SHE SAID IT ¿SPREAD¿ OVER TO THE OTHER EYE, THAT SHE ALSO HAD AN IMPLANT IN. THE LEFT EYE WAS IMPLANTED WITH A NON-JOHNSON AND JOHNSON LENS. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT SAW HER DOCTOR ON (B)(6) 2020 AND WAS TOLD THAT SHE HAS IRITIS AND WAS PRESCRIBED INZELTYS FOR THE INFLAMMATION. SHE WAS INSTRUCTED TO USE 2 TIMES/DAY FOR 2 WEEKS AND 1 TIME/DAY FOR THE FOLLOWING 2 WEEKS THEREAFTER. THE INFLAMMATION HAS CLEARED UP AND SHE IS NO LONGER HAVING ISSUES WITH IRRITATION ON (B)(6) 2020. THE PATIENT IS BEING MONITORED BY HER DOCTOR AND WILL HAVE ANOTHER FOLLOW UP VISIT AFTER THE COVID-19 HOMEBOUND ORDER IS LIFTED. SHE DOES NOT HAVE ANY OTHER SYMPTOMS AND IS SATISFIED WITH

  Patient problems: Inflammation; Iritis; Irritation

  MAUDE report 9999027 ↗
• InjuryJan 30, 2020Break; Break

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE EYE AS A CUT WAS NOTICED AFTER IT WAS IMPLANTED. THERE WAS ALSO UNPLANNED VITRECTOMY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 9650693 ↗
• MalfunctionDec 13, 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 9468594 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RESIDUAL REFRACTIVE ERROR, THEREFORE THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8903116 ↗
• InjuryJun 21, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +22.5 DIOPTER) WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE BECAUSE OF LENS NOT CENTERING PROPERLY. THERE WAS VITRECTOMY PERFORMED. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING FINE AND WAS IN STABLE CONDITION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8720945 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS DEFECTIVE, WHEREIN THE HAPTIC BROKE WHILE THE CUSTOMER WAS TAKING THE LENS OUT OF THE CASE. IT WAS STATED THAT THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8333995 ↗
• MalfunctionJan 8, 2019Break; Break

  REPORTEDLY, THERE WAS A SPLIT IN THE HAPTIC OF A Z9002 WHEN INSERTING INTO THE PATIENT'S EYE. THERE WAS NO SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229723 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED WHEN INSERTING A MODEL Z9002, 22.5 DIOPTER INTRAOCULAR LENS (IOL), THE HAPTIC WAS CRIMPED. THE LENS WAS NOT IMPLANTED IN THE PATIENT'S EYE. THROUGH FOLLOW-UP, CUSTOMER CONFIRMED THE CARTRIDGE TIP HAD PATIENT CONTACT. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACKUP LENS, SAME MODEL AND SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086078 ↗
• MalfunctionOct 25, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE Z9002 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE TRAILING HAPTIC WAS NOTICED TO BE DETACHED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE IOL WAS FULLY INSERTED INTO THE EYE, REMOVED AND REPLACED WITH ANOTHER IOL DURING THE SAME PROCEDURE. THE INCISION WAS NOT ENLARGED, NO SUTURES WERE USED AND NO SECONDARY PROCEDURE WAS REQUIRED. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL, NO POST-OP COMPLICATIONS. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8004007 ↗
• MalfunctionOct 15, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE JEWEL CASE FOR A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002, +22.5 DIOPTER) WAS OPENED, THE LENS WAS FOUND TO HAVE A BROKEN HAPTIC. THERE WAS NO PATIENT INVOLVEMENT. THIS WAS OBSERVED WHILE REMOVING FROM PACKAGING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7968099 ↗
• MalfunctionFeb 2, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) (MODEL Z9002, +22.5 DIOPTER) WAS OBSERVED TORN WHILE INSERTING INTO THE EYE WHICH WAS REMOVED AND REPLACED IN THE SAME SURGERY. A NEW IOL, SAME MODEL AND DIOPER WAS USED AS A REPLACEMENT LENS. PATIENT HAD NO INTRAOPERATIVE OR POST OPERATIVE COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238558 ↗