TECNIS CL IOL Z9002 (REF Z900200260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474530812), received between Mar 15, 2017 and Jan 31, 2023 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL COMPLICATIONS. THE IOL IS NOT AVAILABLE TO RETURN FOR PRODUCT EVALUATION. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT, SUTURES, OR A VITRECTOMY WERE REQUIRED. THE PATIENT HAS FULLY RECOVERED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCU225 24.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 16275454 ↗
• MalfunctionMar 25, 2022Break; Mechanical Problem; Break; Mechanical Problem

  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 13906338 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SPLIT. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657730 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN ONCE THE LENS WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971408 ↗
• InjuryMar 31, 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 EXPLANTED FROM A PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. IT WAS INDICATED THAT THE CLINIC CALCULATIONS PREDICTED A 28.0 DIOPTER (D) LENS, ORA SYSTEM INTRAOPERATIVE ABERROMETER RECOMMENDED 25.5 D AND THE DOCTOR SELECTED 26.0 D. AT THE POST-OP PATIENT¿S VISION REMAINED BLURRY/UNCLEAR AND WAS FOUND TO BE HYPEROPIC. LENS CUTTERS WERE USED TO REMOVE THE ORIGINAL IOL. THE ORIGINAL CLINICAL CALCULATIONS WERE USED AND A 28.0 DIOPTER LENS OF THE SAME MODEL WAS IMPLANTED. THERE WERE NO SUTURES OR INCISION ENLARGEMENT REQUIRED. THE PATIENT DISCHARGED HOME WITHOUT COMPLICATIONS. THE EXPLANTED IOL WAS DISCARDED BY THE ACCOUNT. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF DIABETES, HYPERTENSION AND DRY EYES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11595860 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD HAPTIC ISSUE PRIOR TO INSERTION. BUT IT WAS ALSO STATED THAT THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490430 ↗
• InjuryNov 21, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WHILE PARTIALLY INSERTED, THE HAPTIC TOUCHED THE PATIENT¿S LEFT EYE, BUT DID NOT UNFOLD PROPERLY INTO THE EYE. THE INCISION NEEDED TO BE WIDENED. PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9359712 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED Z9002 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. IOL WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF UNEXPECTED POSTOP REFRACTION. IT WAS REPORTED OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8913899 ↗
• MalfunctionMay 11, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL Z9002 +26.0 DIOPTER) DID NOT UNFOLD PROPERLY INTO THE PATIENT'S OPERATIVE EYE (RIGHT). REPORTEDLY, THE LENS WAS REMOVED. THE INCISION WAS NOT ENLARGED. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509442 ↗
• MalfunctionOct 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SPECK WAS NOTICED ON AN INTRAOCULAR LENS (IOL) DURING HANDLING, BUT PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6989546 ↗
• InjuryMar 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SYMPTOMS WITH THE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN 2009. REPORTEDLY, WHILE SNOWFLAKE DEBRIS/DEPOSIT APPEARS ON THE LENS AND CAN NOT BE LASERED OFF WITH THE YAG LASER. PATIENT COMPLAINS OF DIFFICULTY WITH FILMY VISION WHICH BEGAN 6 MONTHS AGO AND IS AFFECTING BOTH HER EYES. THE EPISODE WAS GRADUAL. THE PATIENT DESCRIBES DRY AND HAZY SYMPTOMS AFFECTING HER EYES/VISION. THE CONDITION'S SEVERITY IS MODERATE. THE PATIENT EXPERIENCED DRY EYES WHICH STARTED 6 MONTHS AGO AND BOTH EYES ARE AFFECTED. THE EPISODE IS GRADUAL AND PATIENT DESCRIBES GLAZY AND HAZY SYMPTOMS AFFECTING BOTH EYES. THE CONDITION'S SEVERITY HAS INCREASED SINCE THE PATIENT'S LAST VISIT. THE CONDITION IS WORSE WITH DAILY ACTIVITIES. THE PATIENT WAS TO RETURN FOR A DIABETES FOLLOW-UP ON BOTH EYES. SINCE HER LAST VISIT, THE AFFECTED AREA HAS NO CHANGES NOTED. THE PATIENT'S VISION IS STABLE. THE DOCTOR WILL CONSIDER A LENS EXCHANGE IF THE PATIENT IS STILL BOTHERED WITH HER VISUAL ACUITY AFTER HER EYE GLASSES PRESCRIPTION IS UPDATED. PATIENT'S DISTANCE VISION WAS 20/50 SC (SANS CORRECTED). NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAS TWO LENSES IMPLANTED; T

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6408306 ↗