TECNIS IOL DFW150 (REF DFW150U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 15.5D CYL1.50 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751170), received between May 10, 2022 and Mar 23, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 Problem2
- Application Program Problem: Dose Calculation Error1
Patient problems
- Halo3
- Visual Disturbances2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT SURGEON WAS SCHEDULED TO EXPLANT THE TORIC INTRAOCULAR LENS (IOL) WITH 15.5D SHORTLY DUE TO MECHANICAL FAILURE. AS PER THE ADDITIONAL INFORMATION RECEIVED, IOL WAS EXPLANTED ON (B)(6) 2024 AND REPLACED WITH ANOTHER IOL OF SAME MODEL AND 13.5D. IOL WAS EXPLANTED DUE TO UNEXPECTED POST OP REFRACTION WHICH WAS DUE TO A CALCULATION ERROR. PATIENT WAS EXPERIENCING HALOS AND PATIENT'S DISTANT VISION WAS BLURRY. THERE WAS NO ANY PATIENT INJURY. THERE WAS NO ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT IS DOING BETTER NOW. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: Blurred Vision; Halo; Visual Impairment
MAUDE report 18965327 ↗InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO GLARE AND HALOS AND ONE OF THE MORE DAILY ACTIVITIES CANNOT BE PERFORMED, LIKE DRIVING. THE LENS WAS REPLACED WITH DIFFERENT MODEL LENS AND DIOPTER J&J LENS. PATIENT HAS FULLY RECOVERED. THERE WAS NO INCISION ENLARGEMENT. THERE WAS NO UNPLANNED VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 18531440 ↗InjuryMay 10, 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 LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT EXPERIENCING HALOS, GLARE, AND REFRACTIVE SURPRISE ISSUES. IT WAS INDICATED THAT ANOTHER JOHNSON & JOHNSON LENS, MODEL DIU150 OF 16.5 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REPORTED. THE PATIENT IS DOING FINE POST-OPERATION AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 14350267 ↗
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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