MAUDE Adverse Event Report: ACUVUE OASYS WITH TRANSITIONS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Loss of Vision (2139)

Event Type  Injury  

Event Description

Acuvue oasys with transitions contacts adverse effect when used in conjunction with hydrogen peroxide-based contact solution: patient recently began using acuvue oasys with transitions contacts.However, after a few uses, patient began experiencing worsening bilateral, cloudy, opaque vision that would develop while wearing the contacts.Per patient, symptoms remained for hours after removal of the contacts with the duration and severity of symptoms directly correlating with the length of time contacts were worn throughout the day.Patient was given two different sample sets of the contacts.Symptoms occurred with both sets of sample contacts as well as pairs from boxes purchased from (b)(6).Similar symptoms occurred with each set of contacts (different manufacture dates/sets).Eventually, we realized that the symptoms would begin after use of hydrogen peroxide based contact solution (clear care).After use of clear care, the symptoms would continue to occur despite switching to regular multipurpose contact solution.With further pairs of contacts, we switched strictly to use of regular multipurpose contact solution without recurrence of symptoms.There appears to be a correlation with use of these specific contacts and hydrogen peroxide-based contact solution as these symptoms occurred bilaterally and consistently with 3 separate pairs of sample contacts.No recurrence of symptoms with use of at least 3 other sets of the transition contacts.

• Brand Name: ACUVUE OASYS WITH TRANSITIONS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 14416267
• MDR Text Key: 291957507
• Report Number: MW5109737
• Device Sequence Number: 4
• Product Code: MSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: MULTIPURPOSE CONTACT LENS SOLUTION
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian