MAUDE Adverse Event Report: COOPER VISION, INC. CLARITY ONE DAY CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Inflammation (1932); Pain (1994); Red Eye(s) (2038); Increased Sensitivity (2065)

Event Date 10/24/2019

Event Type  Injury  

Event Description

Pt presented with bilateral ocular pain, photophobia, conjunctival erythema.Wearing daily disposable contact lenses as extended wear lenses, purchased online, without a valid or verified prescription, x several years.Told by online retailer that lenses were approved for extended wear.Bilateral uveitis with significant keratic precipitates.Fda safety report id# (b)(4).

• Brand Name: CLARITY ONE DAY CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPER VISION, INC. ; new york NY 10023
• MDR Report Key: 9245058
• MDR Text Key: 164283305
• Report Number: MW5090704
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR