TECNIS IOL DFW150 (REF DFW150U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751354), received between Oct 3, 2022 and May 6, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYNERGY TORIC II SIMPLICITY INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE AND THE PATIENT HAS BEEN REPORTING DISTORTION IN VISION AND UNABLE TO SEE CLEARLY. THE DOCTOR HAD REFERRED PATIENT TO A RETINAL SPECIALIST IN (B)(6) 2023 AND WAS CLEARED. AFTER CONSULTING WITH PATIENT AND WITH NO IMPROVEMENT IN VISION, DOCTOR DECIDED TO EXPLANT THE SYNERGY LENS AND REPLACED THE IOL WITH AN OPTIBLUE DXW225 24.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THE PATIENT REPORTS FEELING "MUCH BETTER SINCE THE EXCHANGE". HER VISION IS "GREATLY IMPROVED" 4 DAYS POST OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19256282 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) SHOWED CRACKED AFTER IT WAS INJECTED AND IMPLANTED INTO THE PATIENT¿S LEFT EYE. REPORTEDLY, IT WAS POSSIBLY DUE TO THE INJECTOR OR CARTRIDGE MISALIGNMENT. THE IOL WAS REMOVED AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION SUCH AS PRESCRIPTION MEDICATION, YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT), VITRECTOMY, CAPSULE TEAR, INCISION ENLARGEMENT OR SUTURES. THE PATIENT WAS REPORTED TO BE DOING ¿OK¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206303 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THEY EXPLANTED AN INTRAOCULAR LENS (IOL) FROM A PATIENT¿S LEFT EYE AS THE PATIENT WAS EXPERIENCING HALOS, GLARE AND BLURRED VISION. THE ISSUE WAS FIRST NOTICED A FEW DAYS POST-OP. THE PATIENT WAS SEEN RECENTLY, AND THEY WERE STILL COMPLAINING OF HALOS AND GLARE. THE SYMPTOMS ARE NOT DEBILITATING AND THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, OR SUTURES. ANOTHER JOHNSON AND JOHNSON LENS, MODEL DIU150 OF 23.5 DIOPTER WAS USED AS A REPLACEMENT. THE CUSTOMER DECLINED TO RETURN THE EXPLANTED IOL SAYING IT IS A BIOHAZARD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15526812 ↗