AcrySof™ IQ Vivity™ DAT315 (REF DAT315.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652427159), received between May 25, 2021 and Nov 11, 2022 — classified as 6 injuries.

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

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WASN'T AS GOOD AS EXPECTED, LENS WITH DECREASE IN CONTRAST CONTRIBUTED TO POOR VISION AND THE CLINICAL REASON FOR EXPLANT WAS MACULA POSTOP DID NOT HAVE IDEAL VISUAL POTENTIAL WITH COMPANY LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15778598 ↗
• InjuryFeb 6, 2022Material Opacification; Material Opacification

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD ISSUES WITH LEFT EYE. THE PATIENT COULD NOT SEE VERY FAR AND WAS SEEING HALOS AROUND THE LIGHT. THE PATIENT RIGHT EYE IS NOT PSEUDOPHAKIC, PATIENT IS AFRAID TO HAVE SURGERY DONE IN HIS RIGHT EYE SINCE HIS LEFT EYE IS SO BAD. THE PATIENT HAD TO DRIVE WITH HIS LEFT EYE CLOSED IN ORDER TO BE ABLE TO DRIVE. THE PATIENT IS ALMOST 6 WEEKS POST OPERATIVE AND HAS HAD A YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT, AND STILL CANNOT SEE. THE PATIENT REPORTED THAT, HE IS NOT SURE IF IT IS A PRODUCT ISSUE, HE MENTIONED MOST LIKELY NOT. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13467447 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD EXPERIENCED AN UNEXPECTED OUTCOME DUE TO IRREGULAR ASTIGMATISM AND LARGE HIGH ORDER ABERRATIONS (HOAS) FROM PREVIOUS RADIAL KERATOTOMY (RK). THE ABERRATION FROM RK IS INTERFERING WITH CENTRAL BUTTON ON THE IOL AND DECREASING QUALITY OF VISION. ADDITIONAL INFORMATION WAS PROVIDED BY A SURGICAL COORDINATOR, THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12712355 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT ALL RANGES, DIM AND SEVERE GLARE CAUSING PATIENT TO UNABLE TO DRIVE AT NIGHT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12568809 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION; TROUBLE WITH DISTANCE, NEAR VISION AND READING. THE PATIENT WAS SENSITIVE TO LIGHT AND HAD PAIN. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS ANISOMETROPIC AND HAD HYPEROPIC LASIK. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Pain; Visual Impairment

  MAUDE report 12313456 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE VISUAL OUTCOME. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11878171 ↗