PURESEE IOL DET225 (REF DET225U175)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC PURESEE TOR II SMPCY 17.5D CYL2.25 · Class 3 · Implant
All models of PURESEE IOL (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474819573), received between Sep 17, 2026 and Sep 17, 2026 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a preloaded extended depth of focus (EDOF) toric intraocular lens (IOL) was implanted in the patient's left eye (OS) during cataract surgery. Following implantation, the patient experienced hazy and blurry vision. Preoperative refraction was reported as +0.75 -1.50 x014 with a best spectacle-corrected visual acuity (BSCVA) of 20/60. Postoperative uncorrected visual acuity (UCVA) was reported as 20/30 distance vision with cloudy/blurry vision and J6 near vision. Postoperative refraction was reported as +0.25, postoperative BSCVA was 20/25, and the intended target refraction was -0.03.Clinical evaluation reportedly revealed optic atrophy in the left eye (OS) with depressed visual fields. Optical coherence tomography (OCT) findings were reported as normal, and magnetic resonance imaging (MRI) was ordered to evaluate a potential neuro-ophthalmic etiology. Subsequent follow-up information indicated that the MRI findings were normal. The physician also reported observing a prominent lathe pattern on the anterior surface of the implanted lens.The patient was reportedly dissatisfied with the visual outcome and continued to experience blurry vision following surgery. Th
Patient problems: Blurred Vision
MAUDE report 50805295 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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