MAUDE Adverse Event Report: DECORATIVE COLOR CONTACT LENS

Device Problem Material Integrity Problem (2978)

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Corneal Ulcer (1796); Erythema (1840); Pain (1994)

Event Date 05/29/2016

Event Type  Injury  

Event Description

Patient obtained prescription colored contact lenses from a (b)(6) online website without a prescription, never fit for them decorative contact lens, corneal ulcers both eyes.On (b)(6) 2016 patient reported colored contacts seemed foggy from the time she inserted them but she continued to wear them for 4 hours.Patient came to office with father, unable to open her eyes without anesthetic.Large superior central abrasions were observed in both eyes.Cells in the anterior chamber were trace and grade 2-3 injection of bulbar conjunctiva was noted.Treated with ocuflox every hour and bandage contact lenses.On (b)(6) 2016 patient had redness and pain.Acuity od 20/25 os 20/40 ocuflox was given every 2 hours both eyes.Homatropine dose started, new bandage lenses reinserted due to abrasions still healing.Oasys 8.8, -3.75,- 3.00.On 5-31-2016 visual acuity od 20/25 os 20/25 grade 1 injection of conjunctiva ou corneal staining improved.Ou inserted new bandage contacts.Homatropine given os only.Ocuflox decreased to 4x a day.On (b)(6) 2016 od 20/25 os 20/25 clearer cornea, discontinue bandage contacts.Recommended no contact lenses.Continue with ocuflox qid ou.Cornea healed ou with mild "cutis".Begin pred forte qid ou and taper every 2 days.Recheck 1 week.

• Brand Name: DECORATIVE COLOR CONTACT LENS
• Type of Device: DECORATIVE COLOR CONTACT LENS
• MDR Report Key: 5725537
• MDR Text Key: 47506348
• Report Number: MW5062868
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 54