TECNIS IOL DFR00V (REF DFR00VU165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474750609), received between Nov 4, 2021 and Dec 19, 2023 — classified as 9 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD). THE REASON FOR EXPLANT WAS BLURRINESS SINCE DAY 1 POST-OP VISIT. THE PRIMARY INCISION WAS ENLARGED TO 2.5 MM WITH A KERATOME. ONE OF THE INCISIONS WAS ENLARGED TO 1.5 MM. THE REPLACEMENT WAS A DIB00, 16.5 DIOPTER POWER SIZE IOL. THERE WERE NO MEDICAL OR OTHER SURGICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THE PATIENT IS HAPPY WITH LENS EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 18359270 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. REPLACEMENT LENS INFORMATION IS UNKNOWN. PATIENT STATUS POST-OPERATIVE WAS REPORTED AS FINE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16585823 ↗
• MalfunctionNov 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS MISSING HAPTIC AFTER THE IOL WAS INSERTED INTO THE PATIENT¿S LEFT EYE. THE LENS WAS REMOVED, AND ANOTHER JOHNSON AND JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WERE NO MEDICAL AND/OR SURGICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883238 ↗
• InjuryNov 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 PATIENT'S RIGHT EYE DUE TO BLURRY FOR DISTANCE, INTERMEDIATE AND NEAR VISION. REPLACED WITH A NON-JOHNSON AND JOHNSON INTRAOCULAR LENS (IOL). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. PATIENT DOING WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15776873 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AN EXPLANT WAS PLANNED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT EXPLANT WAS PERFORMED FROM PATIENT'S LEFT EYE AND THE ORIGINAL PRELOADED INTRAOCULAR LENS (IOL) WAS REPLACED WITH ANOTHER LENS OF DIFFERENT MODEL BUT OF SAME DIOPTER. THE PATIENT WAS DISSATISFIED WITH THE ORIGINAL LENS THAT HE HAD BLURRED VISUAL ACUITY, HALOS AND THE LETTERS WERE OVERLAPPING. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/100 AND POST-IMPLANTATION WITH THE ORIGINAL LENS, THE DISTANCE VISION IMPROVED TO 20/20, HOWEVER, THE PATIENT WAS UNHAPPY WITH THE NEAR VISION. AFTER THE EXPLANT AND REPLACEMENT WITH THE NEW LENS, THE VISUAL ACUITY WAS 20/20 -1. THERE WAS NO OTHER PATIENT INJURY AND THE PATIENT WAS VERY HAPPY WITH THE VISION AT DAY 1 POST-OPERATIVE VISIT. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 15676844 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT OF THE INTRAOCULAR LENS (IOL) FROM THEIR RIGHT EYE (OD) DUE TO ISSUES DRIVING AT NIGHTTIME. THE IOL WAS REPLACED WITH A DIFFERENT JOHNSON & JOHNSON LENS, MODEL ZCB00. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS STATED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Visual Disturbances

  MAUDE report 15554183 ↗
• InjuryMar 17, 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 DUE TO EXTREMELY POOR CONTRAST SENSITIVITY AND VISUAL DISTURBANCES. THE LENS WAS DISCARDED. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT STATUS POST-OPERATIVELY IS 20/50 +2 J3. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 13797058 ↗
• InjuryFeb 25, 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 LEFT EYE DUE TO EXPERIENCING CONSTANT BLURRED AND HAZY VISION. ACCOUNT INDICATED THAT THE INCISION WAS ENLARGEMENT; HOWEVER, THERE WERE NO VITRECTOMY OR SUTURES PERFORMED. THE REPLACEMENT LENS WAS OF A DIFFERENT MODEL AND DIOPTER SIZE (MODEL AAB00, +19.0 DIOPTER). THE PATIENT IS REPORTEDLY DOING WELL, STABLE, AND HEALING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13605100 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ENDED UP OU (BOTH EYES) 20/20 J1, BUT COULD NOT TOLERATE THE GLARE AND HALO AFTER THE IMPLANTATION WITH THE SYNERGY INTRAOCULAR LENSES (IOLS). AFTER THE POST-OPERATIVE (OP) 1 MONTH APPOINTMENT, THE LENSES WERE EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON LENSES. THE REPLACEMENT LENSES ARE THE B & L MX60E MONOFOCAL LENSES. THE SUSPECT IOLS WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE LEFT (OS) EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT (OD) EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13511676 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE FROM A PATIENT'S LEFT EYE AS IT HAD A HOLE. LENS WAS DISCARDED AND ONLY CARTRIDGE WILL BE RETURNED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801327 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE MISS +1.00 D. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12754070 ↗