TECNIS IOLRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 1,344 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TECNIS IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10,702
- Deaths reported
- 1
- Injuries reported
- 6,991
- Recalls
- 3
We found 1,344 models of TECNIS IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 10,702 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2016 and Sep 28, 2026 — classified as 1 death, 6,991 injuries, 3,710 malfunctions.
The most frequently reported specific device problem is “Break” (1,491 reports).
3 FDA recall records name at least one of these models by its device identifier, 1 still open.
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
TECNIS IOL recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 6, 2023Open, Classified
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Z-2288-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 27, 2021Terminated
Due to the release of nonconforming Intraocular Lenses (IOLs).
Z-1163-2021 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 21, 2018Terminated
Expired intraocular lenses were distributed.
Z-0464-2019 · Root cause: Process control · names 14 of these models · Recall details · FDA record ↗
Most reported TECNIS IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem5,203
- Break1,491
- Scratched Material471
- Inadequacy of Device Shape and/or Size370
- Unintended Movement358
- Appropriate Device Problem Term/Code Not Available290
- Crack289
- Device Contamination with Chemical or Other Material219
Patient problems
- No Code Available4,028
- No Clinical Signs, Symptoms or Conditions1,580
- Visual Disturbances1,551
- Blurred Vision1,446
- Halo1,138
- No Consequences Or Impact To Patient1,000
- Visual Impairment819
- No Patient Involvement593
TECNIS IOL models
1,344 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TECNIS IOL PCB00intraocular lens146 reports
- TECNIS IOL PCB00intraocular lens145 reports
- TECNIS IOL PCB00intraocular lens144 reports
- TECNIS IOL PCB00intraocular lens139 reports
- TECNIS IOL PCB00intraocular lens129 reports
- TECNIS IOL PCB00intraocular lens127 reports
- TECNIS IOL PCB00intraocular lens126 reports
- TECNIS IOL ZCB00intraocular lens121 reports
- TECNIS IOL PCB00intraocular lens119 reports
- TECNIS IOL PCB00intraocular lens114 reports
- TECNIS IOL PCB00intraocular lens110 reports
- TECNIS IOL ZCB00intraocular lens104 reports
- TECNIS IOL PCB00intraocular lens104 reports
- TECNIS IOL ZCB00intraocular lens103 reports
- TECNIS IOL ZCB00intraocular lens103 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZCB00intraocular lens99 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZA9003intraocular lens93 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZA9003intraocular lens92 reports
- TECNIS IOL ZCB00intraocular lens92 reports
- TECNIS IOL ZCB00intraocular lens91 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZA9003intraocular lens86 reports
- TECNIS IOL ZCB00intraocular lens83 reports
- TECNIS IOL ZA9003intraocular lens1 death82 reports
- TECNIS IOL ZCB00intraocular lens81 reports
- TECNIS IOL ZCB00intraocular lens79 reports
- TECNIS IOL PCB00intraocular lens1 recall26 reports
- TECNIS IOL PCB00intraocular lens1 recall26 reports
- TECNIS IOL PCB00intraocular lens76 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens71 reports
- TECNIS IOL PCB00intraocular lens1 recall20 reports
- TECNIS IOL ZCB00intraocular lens69 reports
- TECNIS IOL PCB00intraocular lens67 reports
- TECNIS IOL PCB00intraocular lens67 reports
- TECNIS IOL ZA9003intraocular lens66 reports
- TECNIS IOL PCB00intraocular lens1 recall16 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens66 reports
- TECNIS IOL PCB00intraocular lens1 recall15 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens65 reports
- TECNIS IOL PCB00intraocular lens1 recall12 reports
- TECNIS IOL ZA9003intraocular lens61 reports
- TECNIS IOL PCB00intraocular lens1 recall11 reports
- TECNIS IOL PCB00intraocular lens1 recall10 reports
- TECNIS IOL PCB00intraocular lens1 recall10 reports
- TECNIS IOL PCB00intraocular lens1 recall10 reports
- TECNIS IOL PCB00intraocular lens1 recall10 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens60 reports
- TECNIS IOL PCB00intraocular lens1 recall9 reports
- TECNIS IOL ZCB00intraocular lens58 reports
- TECNIS IOL ZCT150LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- TECNIS IOL PCB00intraocular lens1 recall5 reports
- TECNIS IOL PCB00intraocular lens1 recall3 reports
- TECNIS IOL ZA9003intraocular lens52 reports
- TECNIS IOL PCB00intraocular lens52 reports
- TECNIS IOL ZA9003intraocular lens51 reports
- TECNIS IOL ZCB00intraocular lens50 reports
- TECNIS IOL ZA9003intraocular lens48 reports
- TECNIS IOL PCB00intraocular lens48 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR48 reports
- TECNIS IOL ZA9003intraocular lens47 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR46 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR46 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens46 reports
- TECNIS IOL ZA9003intraocular lens44 reports
- TECNIS IOL ZCB00intraocular lens44 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens44 reports
- TECNIS IOL PCB00intraocular lens41 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens39 reports
- TECNIS IOL ZA9003intraocular lens38 reports
- TECNIS IOL ZCB00intraocular lens37 reports
- TECNIS IOL PCB00intraocular lens37 reports
- TECNIS IOL ZXT150Extended depth of focus intraocular lens35 reports
- TECNIS IOL DFR00VLens, multifocal intraocular34 reports
- TECNIS IOL PCB00intraocular lens33 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR33 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens33 reports
- TECNIS IOL ZXT150Extended depth of focus intraocular lens33 reports
- TECNIS IOL ZXT150Extended depth of focus intraocular lens33 reports
- TECNIS IOL ZXT150Extended depth of focus intraocular lens32 reports
- TECNIS IOL ZCB00intraocular lens31 reports
- TECNIS IOL ZCB00intraocular lens31 reports
- TECNIS IOL PCB00intraocular lens31 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR31 reports
- TECNIS IOL DFR00VLens, multifocal intraocular31 reports
- TECNIS IOL ZA9003intraocular lens30 reports
- TECNIS IOL ZCB00intraocular lens30 reports
- TECNIS IOL PCB00intraocular lens30 reports
- TECNIS IOL DFR00VLens, multifocal intraocular30 reports
- TECNIS IOL ZXR00Extended depth of focus intraocular lens29 reports
- TECNIS IOL DFR00VLens, multifocal intraocular29 reports
- TECNIS IOL PCB00intraocular lens28 reports
- TECNIS IOL PCB00intraocular lens27 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR27 reports
- TECNIS IOL ZLB00LENS, MULTIFOCAL INTRAOCULAR27 reports
Recent TECNIS IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Impairment
MAUDE report 50926537 ↗MalfunctionSep 25, 2026Manufacturing, Packaging or Shipping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904863 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50892624 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Bag Tear
MAUDE report 50847404 ↗MalfunctionSep 18, 2026Break
It was reported that the haptic of the non-preloaded monofocal intraocular lens (IOL) was found to be broken while preparing the lens for insertion into the eye. There was patient contact with the device. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820637 ↗MalfunctionSep 15, 2026Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781849 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777871 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a preloaded monofocal intraocular lens (IOL) was implanted in the patient's right eye. Initial information indicated that the lens was scheduled for explantation on (b)(6) 2026, for an unspecified reason. Follow-up information later confirmed that the explant procedure was performed due to blurred vision and subjective visual disturbances. Additional information revealed that the event occurred in (b)(6) 2026, approximately one week after implantation, when the patient experienced unsatisfactory visual outcomes. The implanted lens was reported to have significantly overcorrected the patient's astigmatism, resulting in blurred vision at all distances. The patient reported an inability to perform activities that could be completed prior to surgery, including near and distance reading and driving. The explantation was attributed to blurred vision at all distances associated with overcorrection of astigmatism.The lens was explanted as planned and replaced with a DIU150 intraocular lens (+19.5 D). No additional or unplanned surgical interventions, including YAG capsulotomy, unplanned vitrectomy, incision enlargement, or suture placement, were required during the pro
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 50775786 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that, following implantation of the preloaded multifocal intraocular lens (IOL) in the patient's right eye, a mechanical complication of the ocular implant was identified postoperatively. The lens was subsequently explanted during a secondary surgical procedure and replaced with a different lens model and diopter (DEN00V 15.5D).Additional information received from the duplicate file confirmed that the replacement lens serial number was (b)(6). The patient experienced visual disturbances with the implanted Symfony lens and was noted to have a slight myopic outcome. Postoperatively, the patient also reported halos, glare, and blurry vision. No further information was provided.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 50775279 ↗InjurySep 14, 2026Device Dislodged or Dislocated
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50765500 ↗InjurySep 14, 2026Application Program Problem: Dose Calculation Error
Patient problems: Eye Injury
MAUDE report 50763029 ↗InjurySep 1, 2026Device Dislodged or Dislocated
It was reported that a fully implanted three-piece spherical monofocal intraocular lens (IOL) was found to be dislocated on the left eye. The patient symptoms was noted to have persisted for approximately 7.5 years. The issue was observed during a postoperative examination conducted during a site visit. The original lens was subsequently explanted during a secondary surgery and was replaced with a AR40e monofocal intraocular lens (IOL) with a +22.0D. No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy were required. Directions for use was followed. The patient has fully recovered. The patient was fully recovered. No further information was provided.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50553966 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during implantation of a single-piece non-preloaded monofocal intraocular lens (IOL), the capsule broke. As a result, the doctor did not implant the reported lens and opted to use a AR40e lens model to complete the procedure. The event occurred during implantation/application. The product was not available for return for investigation. No further information was provided.
Patient problems: Capsular Bag Tear
MAUDE report 50553720 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532643 ↗InjuryAug 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 50510067 ↗
Other Johnson & Johnson Surgical Vision, Inc. products
- FS DISPOSABLE INTERFACE2 models · 4,239 reports
- TECNIS SIMPLICITY112 models · 2,730 reports · 1 recall
- SENSAR IOL112 models · 1,213 reports
- TECNIS CL IOL42 models · 558 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.
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