TECNIS CL IOLRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 558
- Deaths reported
- 0
- Injuries reported
- 242
- Recalls
- 0
We found 42 models of TECNIS CL IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 558 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2016 and Sep 23, 2026 — classified as 242 injuries, 316 malfunctions.
The most frequently reported specific device problem is “Break” (152 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TECNIS CL IOL problems
Device problems
- Break152
- Adverse Event Without Identified Device or Use Problem144
- Material Split, Cut or Torn55
- Scratched Material35
- Inaccurate Delivery26
- Material Fragmentation22
- Inadequacy of Device Shape and/or Size20
- Torn Material18
Patient problems
- No Code Available184
- No Clinical Signs, Symptoms or Conditions174
- No Patient Involvement52
- No Consequences Or Impact To Patient45
- No Known Impact Or Consequence To Patient38
- Vitrectomy34
- Capsular Bag Tear25
- Blurred Vision20
TECNIS CL IOL models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TECNIS CL IOL Z9002intraocular lens48 reports
- TECNIS CL IOL Z9002intraocular lens47 reports
- TECNIS CL IOL Z9002intraocular lens45 reports
- TECNIS CL IOL Z9002intraocular lens43 reports
- TECNIS CL IOL Z9002intraocular lens40 reports
- TECNIS CL IOL Z9002intraocular lens34 reports
- TECNIS CL IOL Z9002intraocular lens32 reports
- TECNIS CL IOL Z9002intraocular lens28 reports
- TECNIS CL IOL Z9002intraocular lens27 reports
- TECNIS CL IOL Z9002intraocular lens27 reports
- TECNIS CL IOL Z9002intraocular lens26 reports
- TECNIS CL IOL Z9002intraocular lens20 reports
- TECNIS CL IOL Z9002intraocular lens17 reports
- TECNIS CL IOL Z9002intraocular lens17 reports
- TECNIS CL IOL Z9002intraocular lens12 reports
- TECNIS CL IOL Z9002intraocular lens11 reports
- TECNIS CL IOL Z9002intraocular lens8 reports
- TECNIS CL IOL Z9002intraocular lens8 reports
- TECNIS CL IOL Z9002intraocular lens8 reports
- TECNIS CL IOL Z9002intraocular lens7 reports
- TECNIS CL IOL Z9002intraocular lens5 reports
- TECNIS CL IOL Z9002intraocular lens5 reports
- TECNIS CL IOL Z9002intraocular lens5 reports
- TECNIS CL IOL Z9002intraocular lens4 reports
- TECNIS CL IOL Z9002intraocular lens4 reports
- TECNIS CL IOL Z9002intraocular lens3 reports
- TECNIS CL IOL Z9002intraocular lens3 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens2 reports
- TECNIS CL IOL Z9002intraocular lens1 report
- TECNIS CL IOL Z9002intraocular lens1 report
- TECNIS CL IOL Z9002intraocular lens1 report
- TECNIS CL IOL Z9002intraocular lens1 report
- TECNIS CL IOL Z9002intraocular lens1 report
- TECNIS CL IOL Z9002intraocular lens1 report
Recent TECNIS CL IOL adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 25, 2024Material Opacification; Material Opacification
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NON-PRELOADED INTRAOCULAR LENS (IOL) IN 2009. SHE IS NOW (B)(6) AND THE SURGEON DESCRIBED APPEARANCE A "SPLATTER" LOOKING SUBSTANCE ON THE LENS. IT DOES NOT APPEARED TO BE THE PATIENT ANATOMY. THERE WAS PLAN TO EXPLANT THE LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE VISUAL ACUITY VALUES ARE LESS THAN 20/400. THE PATIENT HAD LOST 2 OR MORE LINES OF BSCVA. (BEST SPECTACLE CORRECTED VISUAL ACUITY). THE SYMPTOMS OF VISUAL ACUITY HAD STARTED YEARS AGO. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20303747 ↗InjuryMar 8, 2024Material Opacification; Material Opacification
IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE AS THE LENS HAD CALCIFIED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867215 ↗InjuryMar 5, 2024Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S HAD CLOUDINESS IN THE LEFT EYE AFTER IMPLANTATION OF THE NON PRELOADED INTRAOCULAR LENS (IOL). THE IMPLANT WAS PLACED 7-8 YEARS AGO. THE LENS WAS NOT REPLACED. IT IS REPORTED THAT THE EXPLANT OF LENS WILL OCCUR IN THE NEXT COUPLE OF WEEKS. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Corneal Clouding/Hazing
MAUDE report 18841151 ↗MalfunctionApr 6, 2023Break; Break
IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DEFECTIVE. IT WAS NOTED THAT THE LENS WAS OPENED AND NOT USED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16696655 ↗MalfunctionApr 6, 2023Break; Break
IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS NOTED THAT THE LENS WAS OPENED AND NOT USED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16696640 ↗MalfunctionApr 5, 2023Break; Break
IT WAS REPORTED THE Z9002 INTRAOCULAR LENS (IOL) WAS DAMAGED WHILE LOADING AND EXTENT OF PATIENT CONTACT IS UNKNOWN. IT IS UNKNOWN IF THE INCISION WAS ENLARGED, UNKNOWN IF SUTURE(S) WERE REQUIRED, AND UNKNOWN FOR VITRECTOMY. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16686938 ↗MalfunctionMar 27, 2023Break; Break
RECEIVED REPORT INDICATING THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16621574 ↗InjuryFeb 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS INDICATED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO COMPLICATION WITH THE LENS. A NON-JOHNSON AND JOHNSON SULCUS LENS OF A DIFFERENT DIOPTER (28.0 D) WAS USED AS THE REPLACEMENT. A VITRECTOMY WAS PERFORMED, AND SUTURE WAS USED. IT WAS INDICATED THAT THE PATIENT IS HEALING WELL. ADDITIONALLY, IT WAS EXPLAINED THAT AT THE TIME OF CATARACT SURGERY IN 2021, THE PATIENT DID NOT HAVE A GOOD EYE HEALTH TO START WITH. THAT THIS WAS A COMPLEX CATARACT SURGERY WHICH LYSIS OF SYNECHIA WAS REPORTED ON (B)(6) 2021, THERE WAS DISCONTINUOUS CAPSULE AND THE PATIENT HAD BLURRY VISION. BUT THE ACCOUNT WAS NOT SURE IF THIS INFORMATION PERTAINED TO PATIENT'S ISSUES PRIOR TO CATARACT SURGERY OF AFTER THE LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Capsular Bag Tear
MAUDE report 16439982 ↗InjuryFeb 2, 2023Adverse 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 DURING A SECONDARY SURGICAL PROCEDURE DUE TO ANISOCORIA IN THE LEFT EYE. THE ISSUE WAS FIRST OBSERVED DURING THE POST OPERATIONAL EXAMINATION. THE DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (DCB00, 21.0 D) WAS USED. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS INDICATED. THE PATIENT HAS FULLY RECOVERED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16286680 ↗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 ↗MalfunctionNov 29, 2022Break; Break
IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S LEFT EYE, IT WAS NOTED THAT THE TRAILING HAPTIC WAS DAMAGED. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON LENS, MODEL ZA9003 OF 23.0 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15883266 ↗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 ↗InjuryOct 27, 2022Adverse 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 PATIENT'S RIGHT EYE DUE TO SILICONE OIL. ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THERE WAS RETINAL DETACHMENT AND THE LENS WAS EXPLANTED ALONG WITH RESIDUAL SILICONE OIL. POST-EXPLANT, THE PATIENT WAS HEALING WELL WITH ELEVATED INTRAOCULAR PRESSURE OBSERVED ON DAY 1 POST-OPERATION THAT IMPROVED WITH DECOMPRESSION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Retinal Detachment
MAUDE report 15687001 ↗
Other Johnson & Johnson Surgical Vision, Inc. products
- TECNIS IOL1,344 models · 10,702 reports · 3 recalls
- FS DISPOSABLE INTERFACE2 models · 4,239 reports
- TECNIS SIMPLICITY112 models · 2,730 reports · 1 recall
- SENSAR IOL112 models · 1,213 reports
- TECNIS ODYSSEY IOL49 models · 389 reports
- TECNIS ODYSSEY TORIC II IOL106 models · 285 reports
- UNFOLDER EMERALD2 models · 258 reports
- LAMINAR13 models · 203 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page