TECNIS IOL DFW300 (REF DFW300U190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 19.0D CYL3.00 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474752429), received between May 4, 2022 and Aug 16, 2022 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2022Adverse 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 DUE TO BLURRY VISION. THE PATIENT HAD A LOSS OF 2 OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). A PLANNED VITRECTOMY WAS PERFORMED; HOWEVER, IT WAS INDICATED THAT THERE WAS NO CAPSULE TEAR. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT IOL. NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED AND THERE ARE NO PLANS FOR ANY ADDITIONAL SURGERIES. THE PATIENT OUTCOME WAS GOOD, AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15238008 ↗InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN (B)(6) 2022 IS NOT TOLERATING THE LENS, PATIENT PROVIDED EXPERIENCING "SPIDERWEB" WITH THE IMPLANT. PATIENT'S VISUAL ACUITY (VA) IS 20/25 WITH MILD REFRACTIVE ERROR CORRECTED. IT WAS CONFIRMED THAT 3 MONTHS POST-IMPLANT, EXPLANT OCCURRED. NO CONCURRENT VITRECTOMY AND SUTURES WERE PERFORMED. THE REPLACEMENT LENS WAS OF A DIFFERENT MODEL BUT SAME DIOPTER POWER (MODEL DIU300, 19.0D). THE PATIENT COULD ALREADY TELL THE SPIDERWEB/HALO IS GONE POST-OPERATIVELY, EVEN THOUGH PATIENT STILL HAS EDEMATOUS CORNEA. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 14283574 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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