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TECNIS IOL DFW300 (REF DFW300U165)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 16.5D CYL3.00 · Class 3 · Implant

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 05050474752375), received between May 31, 2022 and May 31, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Halo1
  • Visual Disturbances1
  • Visual Impairment1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT COULD NOT ADJUST WITH AN INTRAOCULAR LENS (IOL) . THE IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE SURPRISE. NO ALLEGATION TOWARDS LENS; ISSUE IS PATIENT NOT ADAPTING WITH THE LENS. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE CUSTOMER DID NOT KNOW HOW THE PATIENT WAS DOING POST-OPERATIVELY (OP), BUT THINKS OUTCOME WAS GREAT. UPON FOLLOW-UP, IT WAS LEARNT THAT THE PATIENT HAD UNCORRECTED VISUAL ACUITY (VA) FLUCTUATED FROM 20/40 TO 20/50 WITH HYPEROPIC OUTCOME OF +0.50+0.25X135. WITH CORRECTION, THE PATIENT COULD NOT GET BETTER THAN 20/25 AND WAS VERY DISSATISFIED WITH GLARE/HALOS DAY AND NIGHT IN ALL SITUATIONS. THE PATIENT COULD NOT WORK AT THE COMPUTER DUE TO DISCOMFORT. GAVE 6 MONTHS TO ADAPT PRIOR TO PROCEEDING WITH EXCHANGE. ANOTHER JOHNSON & JOHNSON DCB00 LENS (DIFFERENT MODEL AND 22.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. REFRACTIVE INFORMATION WAS NOT AVAILABLE AS IT WAS ONLY ONE WEEK POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Halo; Visual Disturbances; Visual Impairment

    MAUDE report 14554978 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.