AcrySof™ IQ Vivity™ DFT415 (REF DFT415.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652422093), received between Oct 14, 2022 and Mar 6, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  A CONSUMER REPORTED THAT AFTER UNDERGOING PHACOEMULSIFICATION PHACECTOMY, WITH IMPLANTATION OF THE EXTENDED FOCUS INTRAOCULAR LENS (IOL), CONSUMER EXPERIENCED BLURRING AND DEFOCUSING OF THE IMAGES SEEN AT MEDIUM AND LONG DISTANCES. THERE WERE NO COMPLICATIONS EITHER DURING OR AFTER SURGICAL PROCEDURE, WHICH WAS DULY MONITORED BY THE SURGEON. THE SURGEON CARRIED OUT RETINAL MAPPING AND OPTICAL COHERENCE TOMOGRAPHY, MACULA MONOCULAR EXAMS, WITH THE AIM OF VERIFYING THE PROBABLE CLINICAL FACTORS THAT COULD BE CAUSING THIS COMPLAINT OF BLURRED VISION AT MEDIUM AND LONG DISTANCES. THE SURGEON ANALYZED THE REPORTS OF THE AFOREMENTIONED EXAMINATIONS AND FOUND NO FACTOR RELATED TO THE COMPLAINT. FURTHERMORE, THE SURGEON EXAMINED AND VERIFIED THE FIXATION AND CENTERING OF THE IMPLANTED LENSES SEVERAL TIMES. FACED WITH THIS SITUATION, THE OPHTHALMOLOGIST PRESCRIBED GLASSES TO CORRECT THE VISUAL IMPAIRMENT NOT CORRECTED BY THE IMPLANTED LENSES, SINCE CLINICALLY IT WOULD NOT BE ADVISABLE TO REPLACE THEM. MORE THAN THREE MONTHS AFTER THE LENS WAS IMPLANTED, IT WAS STILL CAUSING SHADOWS AROUND OBJECTS AND LETTERS AND BLURRING OF VISION. IN ADDITION, FROM TIME TO TIME, THERE WAS A SORT OF "OPAQUE

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18845438 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER UNDERGOING PHACOEMULSIFICATION PHACECTOMY, WITH IMPLANTATION OF THE EXTENDED FOCUS INTRAOCULAR LENS (IOL), CONSUMER EXPERIENCED BLURRING AND DEFOCUSING OF THE IMAGES SEEN AT MEDIUM AND LONG DISTANCES. THERE WERE NO COMPLICATIONS EITHER DURING OR AFTER SURGICAL PROCEDURE, WHICH WAS DULY MONITORED BY THE SURGEON. THE SURGEON CARRIED OUT RETINAL MAPPING AND OPTICAL COHERENCE TOMOGRAPHY, MACULA MONOCULAR EXAMS, WITH THE AIM OF VERIFYING THE PROBABLE CLINICAL FACTORS THAT COULD BE CAUSING THIS COMPLAINT OF BLURRED VISION AT MEDIUM AND LONG DISTANCES. THE SURGEON ANALYZED THE REPORTS OF THE AFOREMENTIONED EXAMINATIONS AND FOUND NO FACTOR RELATED TO THE COMPLAINT. FURTHERMORE, THE SURGEON EXAMINED AND VERIFIED THE FIXATION AND CENTERING OF THE IMPLANTED LENSES SEVERAL TIMES. FACED WITH THIS SITUATION, THE OPHTHALMOLOGIST PRESCRIBED GLASSES TO CORRECT THE VISUAL IMPAIRMENT NOT CORRECTED BY THE IMPLANTED LENSES, SINCE CLINICALLY IT WOULD NOT BE ADVISABLE TO REPLACE THEM. MORE THAN THREE MONTHS AFTER THE LENS WAS IMPLANTED, IT WAS STILL CAUSING SHADOWS AROUND OBJECTS AND LETTERS AND BLURRING OF VISION. IN ADDITION, FROM TIME TO TIME, THERE WAS A SORT OF "OPAQUE

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 18835154 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAS DIFFICULTIES WITH CLARITY IN CHANGES IN THE ENVIRONMENT, DOES NOT SEE WELL AT THE LONG AND INTERMEDIATE DISTANCE, THAT THE OBJECTS IN ITS PERIPHERAL VISION SEEM MISALIGNED. THE PATIENT STATED THAT, AFTER THE SURGERY, THE PATIENT NO LONGER HAD ANY QUALITY OF LIFE, HE WAS UNABLE TO DRIVE, USE A COMPUTER AND COULD NOT EVEN SEE A PERSON ACROSS THE STREET.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18737418 ↗
• MalfunctionOct 14, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED DURING IMPLANTATION AND THEN IT WAS REMOVED AND REPLACED WITH SAME MODEL LENS. THERE WAS NO PATIENT HARM. THE PATIENT WAS NOT HOSPITALIZED IN RESPONSE TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603186 ↗