MAUDE Adverse Event Report: REFRACTIVE CLEAR LENS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Pain (1994); Blurred Vision (2137); Burning Sensation (2146); Halo (2227); Discomfort (2330)

Event Date 07/06/2017

Event Type  Injury  

Event Description

Had clear lens extraction in right eye, i now have eye pain and burning all the time, my vision is blurry and i can no longer read with my right eye, i see starbursts, haloes, ghosting and glare day and night.My vision is cloudy in low light and feels very uncomfortable, my eye now gets very tired and i have to close it often.

• Brand Name: REFRACTIVE CLEAR LENS
• Type of Device: REFRACTIVE CLEAR LENS
• MDR Report Key: 7402326
• MDR Text Key: 104660221
• Report Number: MW5076360
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 62