TECNIS IOL DFR00V (REF DFR00VU175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474750623), received between Dec 16, 2021 and Sep 11, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE AND AFTER IMPLANTATION, SCRATCH WAS NOTED ON THE OPTIC. REPORTEDLY, THE PRELOADED IOL WAS REMOVED AND REPLACED WITH THE BACK-UP IOL. THERE WAS NO PATIENT INJURY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT GIVEN. THE PATIENT¿S OUTCOME, STATUS IS GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17721017 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED MULTIFOCAL INTRAOCULAR LENS(IOL) WAS EXPLANTED AND REPLACED WITH DIFFERENT LENS AS THE PATIENT COMPLAINED ABOUT DYSPHOTOPSIA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17501311 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED RLE (REFRACTIVE LENS EXCHANGE), THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE. THE PATIENT COULD NOT DRIVE AT NIGHT DUE TO HALOS, GLARES AND GHOSTING AND REQUESTED FOR AN EXPLANT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. THE SUSPECT LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO PATIENT POST-OP INJURY REPORTED. THE LENS WAS DISCARDED AND WILL NOT BE RETURNED. PATIENT OUTCOME WITH SYNERGY LENS, VISUAL ACUITY WITHOUT CORRECTION (VA SC) 20/25 J2 ¿ 20-DAYS POST OPERATION (PO) ¿ PATIENT STILL REPORTS DOUBLE VA- GHOSTING, GLARE, AND HALOS. PATIENT STATES SHE IS UNABLE TO DRIVE WITH THESE SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16881629 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION AND INTOLERABLE HALOS AND GLARE IN THEIR RIGHT EYE (OD) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). DISTANCE VISION WAS 20/40 AND THE PATIENTS NEAR WAS J7. THROUGH FOLLOW-UP, IT WAS LEARNED THAT PATIENT COULD NOT TOLERATE THE LENS WAS VISION IS WORSE. DISTANCE VISION IS VERY BLURRY. THE PATIENT'S PRE-OPERATIVE (OP) UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/40 DISTANCE AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS J5 NEAR 20/25 DISTANCE. POST-OPERATIVE ON (B)(6) 2022 UCVA WAS 20/40-1 DISTANCE AND J3- NEAR AND BCVA WAS 20/40+1 -DISTANCE AND J2-NEAR. ON (B)(6) 2022 UCVA WAS 20/40 DISTANCE AND J10 NEAR AND BCVA WAS 20/25. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15687046 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNBEARABLE HALOS, SHADOWING, AND INABILITY TO FUNCTION WITH THE INTRAOCULAR LENS (IOL) . PATIENT ADDITIONALLY HAD POSTERIOR CAPSULAR OPACIFICATION (PCO) AND DECIDED TO HAVE IOL EXPLANTED INSTEAD OF HAVING A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE. VISUAL ACUITY (VA) PRE-OPERATIVE (OP) WAS 20/50 -2, VA POST-OP WAS 20/50 DOUBLING CORRECTED VISION WAS 20/20. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON ZCB00 LENS (DIFFERENT MODEL AND 18.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING PRETTY WELL POST-OPERATIVELY. THE IOL WILL NOT BE RETURNING FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 14650668 ↗
• InjuryDec 16, 2021Adverse 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 FORM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION AND REDUCED VISUAL ACUITY. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH AN 0.5 HIGHER DIOPTER POWER THAN THE SUSPECT IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. THE PATIENT IS GOOD POST-OPERATIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13021983 ↗