ACUVUE Abiliti Overnight Therapeutic lenses for myopia managementRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00192538951357), received between Jul 14, 2023 and Mar 19, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 27FEB2025, JOHNSON AND JOHNSON VISION CARE (JJVC) EMPLOYEE SENT AN EMAIL TO THE ACUVUE ABILITI¿ OVERNIGHT BRAND CONTACT LENS (CL) MANUFACTURING SITE (MENICON B.V.) INFORMING THEM OF THE FOLLOWING ADVERSE EVENT. MENICON B.V. RECORDED IT AS COMPLAINT ID: (B)(4) AND INFORMED THE MANUFACTURER (MENICON CO.). ADVERSE EVENT INFORMATION: ON 13FEB2025, AN EMAIL SENT BY A JOHNSON AND JOHNSON EMPLOYEE ADVISED A PATIENT (PT) WAS DIAGNOSED WITH A "POSSIBLE CORNEAL INFECTION" WITH A RESULTING SCAR THAT DOES NOT IMPACT THE VISUAL ACUITY (VA) WHILE WEARING AN ACUVUE ABILITI¿ OVERNIGHT BRAND CL. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. THE TREATING EYE CARE PROFESSIONAL (ECP) REPORTED THE PT EXPRESSED SYMPTOMS OF "UNCOMFORTABLE AND IRRITATED" WHILE WEARING THE LEFT EYE (OS) CL ON (B)(6) 2024. THE PT WAS SEEN ON (B)(6) 2024 WITH FINDINGS OF CENTRAL CORNEAL EDEMA AND LIGHT SENSITIVITY. THE PT WAS PRESCRIBED LOTEMAX FOUR TIMES DAILY (QID). THE PT WAS SEEN BY THE ECP FOR ADDITIONAL FOLLOW-UP (FU) VISITS ON (B)(6) 2024. THE ECP REPORTS THAT THE PT WAS ALSO SEEN ON (B)(6) 2025 AND IS 20/20 WITH OU CORRECTION. ON 28FEB2025, WE OBTAINED ADDITIONAL INFORMATION FROM JJVC. THE TREATING ECP REPO

  Patient problems: Corneal Edema; Corneal Infiltrates; Corneal Scar; Eye Irritation; Eye Pain; Photophobia

  MAUDE report 21639997 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28FEB2025, JOHNSON AND JOHNSON VISION CARE (JJVC) EMPLOYEE SENT AN EMAIL TO THE ACUVUE ABILITI¿ OVERNIGHT BRAND CONTACT LENS (CL) MANUFACTURING SITE (MENICON B.V.) INFORMING THEM OF THE FOLLOWING ADVERSE EVENT. MENICON B.V. RECORDED IT AS COMPLAINT ID (B)(4) AND INFORMED THE MANUFACTURER (MENICON CO.). ADVERSE EVENT INFORMATION: ON 13FEB2025, AN EMAIL SENT BY A JOHNSON AND JOHNSON EMPLOYEE ADVISED A PATIENT (PT) WAS DIAGNOSED WITH A "POSSIBLE CORNEAL INFECTION" WITH A RESULTING SCAR THAT DOES NOT IMPACT THE VISUAL ACUITY (VA) WHILE WEARING AN ACUVUE ABILITI¿ OVERNIGHT BRAND CL. ON 26FEB2025, ADDITIONAL INFORMATION WAS RECEIVED. THE TREATING EYE CARE PROFESSIONAL (ECP) REPORTED THE PT WAS IN THE OFFICE ON (B)(6) 2025, ASYMPTOMATIC, AND WAS PRESCRIBED LOTEMAX FOUR TIMES DAILY (QID). THE PT WAS SEEN BY THE ECP FOR ADDITIONAL FOLLOW-UP (FU) VISITS ON (B)(6) 2025 AND (B)(6) 2025 WITH "SLOW IMPROVEMENTS OF EDEMA". ON 28FEB2025, ADDITIONAL INFORMATION WAS PROVIDED: THE TREATING ECP REPORTED THAT THE PT EXPERIENCED A "CORNEAL INFILTRATE LIKE AN IMMUNE RESPONSE WITH WHITE CELLS, BUT NOT INFECTIOUS AS PT WAS TREATED WITH LOTEMAX QID FOR 1 WEEK AND NEVER USED ANTIBIOTICS TO TREAT THE PT."

  Patient problems: Corneal Edema; Corneal Infiltrates; Corneal Scar

  MAUDE report 21639991 ↗
• InjuryJul 14, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ON 10JUL2023, THE SUSPECT PRODUCT WAS RECEIVED BY JOHNSON AND JOHNSON VISION CARE, INC., AND RETURNED TO MENICON FOR EVALUATION ON 13JUL2023. ON 14JUL2023, MENICON CONDUCTED THE EVALUATION. DETAILS OF THE EVALUATION RESULTS ARE SHOWN IN B6. THE CONCLUSION OF THE EVALUATION WAS THAT NO DEVIATIONS WERE DETECTED DURING THE SPECIFICATION AND GENERAL INSPECTIONS. AS A RESULT OF THE CORNEA TREATMENT, THE PATIENT (PT) RECOVERED WITH LITTLE SCARRING AND RETURNED TO WEARING CONTACT LENSES. PROPER HANDLING AND REGULAR EYE EXAMINATIONS ARE DESCRIBED IN THE INSTRUCTIONS FOR PATIENTS. UNCLEAR HOW THE PT WAS GUIDED BY THE EYE CARE PROFESSIONAL.

  Patient problems: Corneal Ulcer; Eye Pain

  MAUDE report 17325409 ↗