TECNIS IOL DFR00V (REF DFR00VU115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474750500), received between Nov 11, 2021 and May 31, 2023 — classified as 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2023Adverse 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 THE PATIENT'S LEFT EYE. IT WAS LEARNED THAT SUSPECT IOL WAS REPLACED WITH A DCB00. 12.0 D POWER IOL. THE PATIENT HAD UNCOMPLICATED PLACEMENT OF A SYNERGY IOL IN THE LEFT EYE, AND AN UNEVENTFUL POSTOPERATIVE COURSE. THE PATIENT WAS NOT SATISFIED WITH THE QUALITY OF DISTANCE OR NEAR VISION FOUR WEEKS AFTER SURGERY DESPITE EXCELLENT IOL CENTRATION, A CLEAR CAPSULE, AND NEAR PLANO REFRACTIVE ERROR. AT THAT TIME HE WAS FOUND TO HAVE SUBTLE EPITHELIAL BASEMENT MEMBRANE DYSTROPHY IN BOTH EYES WHICH WAS FELT TO BE THE CAUSE OF AN INADEQUATE VISUAL OUTCOME. THIS WAS EXPLAINED TO THE PATIENT WHO DESIRED EXCHANGE FOR A MONOFOCAL IOL. THE EXCHANGE WAS UNCOMPLICATED. THE WOUND WAS ENLARGED TO 2.75 MM USING A KERATOME. NO SUTURE WAS NEEDED. THE PATIENT WAS SEEN FOR HIS ONE DAY POSTOP VISIT AND WAS HEALING NORMALLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17035588 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO HAD BILATERAL LENS IMPLANTATION REPORTED OF EXTREME NIGHTTIME GLARE IN BOTH EYES WHICH SYMPTOMS APPEARED SHORTLY AFTER INITIAL SURGERIES. AFTER THE FIRST EYE (LEFT EYE) SURGERY, THE PATIENT COULD SEE COLOR CRISPER AND HER VISION WAS SO CLEAR EXCEPT FOR DISTANCE. AS THE NEXT WEEK WENT ON, THE PATIENT WAS HAVING TROUBLE DRIVING AT NIGHT. THE HALOS AROUND ALL LIGHTS AT NIGHT WAS MAKING IT ALMOST IMPOSSIBLE TO DRIVE. THE PATIENT HAD NO DEPTH PERCEPTION OF THE CAR IN FRONT OF HER AND IT WAS SCARY. AFTER THE SECOND SURGERY THE PATIENT HAD THE SAME ISSUE WITH THE LEFT EYE. THE DOCTOR ADVISED THE PATIENT THAT IT MAY TAKE 6 MONTHS OR LONGER FOR THE HALOS TO GO AWAY. AFTER A FEW MONTHS THE DOCTOR SUGGESTED THAT THE PATIENT TRY CONTACT LENSES TO HELP WITH THE HALOS. THE CONTACTS DID NOT HELP AT ALL, AND THE PATIENT WAS SO FRUSTRATED WITH THE LENSES AND THE HALOS. THE DOCTOR THEN SUGGESTED TO TRY TWO DIFFERENT TYPES OF DROPS THAT COULD POSSIBLY HELP WITH THEM. ONE DROP WAS ALPHAGAN .01% AND THE SECOND WAS VUITY. THE PATIENT TRIED THE FIRST DROP FOR A TWO-WEEK TIME FRAME AN HOUR BEFORE SHE WAS TO DRIVE AND THE VUITY FOR ABOUT A MONTH. NEITHER DROP HELPED THE PATIENT, SO AT

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16964477 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO HAD BILATERAL LENS IMPLANTATION REPORTED OF EXTREME NIGHTTIME GLARE IN BOTH EYES WHICH SYMPTOMS APPEARED SHORTLY AFTER INITIAL SURGERIES. AFTER THE FIRST EYE (LEFT EYE) SURGERY, THE PATIENT COULD SEE COLOR CRISPER AND HER VISION WAS SO CLEAR EXCEPT FOR DISTANCE. AS THE NEXT WEEK WENT ON, THE PATIENT WAS HAVING TROUBLE DRIVING AT NIGHT. THE HALOS AROUND ALL LIGHTS AT NIGHT WAS MAKING IT ALMOST IMPOSSIBLE TO DRIVE. THE PATIENT HAD NO DEPTH PERCEPTION OF THE CAR IN FRONT OF HER AND IT WAS SCARY. AFTER THE SECOND SURGERY THE PATIENT HAD THE SAME ISSUE WITH THE LEFT EYE. THE DOCTOR ADVISED THE PATIENT THAT IT MAY TAKE 6 MONTHS OR LONGER FOR THE HALOS TO GO AWAY. AFTER A FEW MONTHS THE DOCTOR SUGGESTED THAT THE PATIENT TRY CONTACT LENSES TO HELP WITH THE HALOS. THE CONTACTS DID NOT HELP AT ALL, AND THE PATIENT WAS SO FRUSTRATED WITH THE LENSES AND THE HALOS. THE DOCTOR THEN SUGGESTED TO TRY TWO DIFFERENT TYPES OF DROPS THAT COULD POSSIBLY HELP WITH THEM. ONE DROP WAS ALPHAGAN .01% AND THE SECOND WAS VUITY. THE PATIENT TRIED THE FIRST DROP FOR A TWO-WEEK TIME FRAME AN HOUR BEFORE SHE WAS TO DRIVE AND THE VUITY FOR ABOUT A MONTH. NEITHER DROP HELPED THE PATIENT, SO AT

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16959604 ↗
• InjuryJan 26, 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 THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT COMPLAINT OF BAD RAINBOW HALOS. A DIFFERENT MODEL IOL (EYHANCE) OF THE SAME DIOPTER POWER WAS USED AS THE REPLACEMENT LENS. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED. NO PATIENT INJURY WAS REPORTED. THE DOCTOR PROVIDED THAT THE PATIENT¿S OUTCOME WAS EXCELLENT AS THE PATIENT LOST HER READING CAPABILITY AFTER THE IOL EXCHANGE, BUT THE SYMPTOM OF ¿RAINBOW HALO¿ COMPLETELY WENT AWAY. THE LENS WAS DISCARDED AFTER IT WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 13361558 ↗
• MalfunctionNov 11, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE), IT WAS OBSERVED THAT LENS EXHIBITED DAMAGE (COSMETIC). THE IOL WAS REMOVED AND REPLACED A BACK-UP LENS WITH NO COMPLICATIONS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO DELAY IN PROCEDURE, AND NO MEDICATION WAS PRESCRIBED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801291 ↗