TECNIS IOL DFW300 (REF DFW300U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 19.5D CYL3.00 · Class 3 · Implant
- 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 05050474752436), received between Jan 19, 2023 and Jan 29, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Eye Injury1
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE, WITH UNKNOWN REASON FOR EXPLANT. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION. THERE WAS NO MEDICAL /SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 18603204 ↗InjuryJan 19, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE LEFT EYE, THE TORIC IOL MOVED. ON (B)(6) 2022, THE IOL WAS PERFECT, HOWEVER ON (B)(6) 2022, THE IOL HAD ROTATED 10 DEGREES AND 1MM INFERIOR DECENTRATION. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED DUE TO GLARE AND DECREASED DISTANCE VISION. THE PATIENT IS NOT HAPPY WITH DISTANCE VISION. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/40 WITH CORRECTION (CC), AND POST-OPERATIVE VA WAS 20/20 CC. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED FOR THIS ISSUE. THE IOL WILL BE EXPLANTED DURING A SECONDARY PROCEDURE, BUT IT HAS NOT YET OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances
MAUDE report 16212249 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.