MAUDE Adverse Event Report: ACUFOCUS INC. CLEAR SIGHT KAMRA CORNEAL IMPLANT; IMPLANT, CORNEAL REFRACTIVE

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Halo (2227); No Code Available (3191)

Event Date 06/09/2016

Event Type  Injury  

Event Description

Lasik surgery on both eyes.Insertion of kamra corneal inlay into left eye by dr.(b)(6) at (b)(6) in (b)(6).Right eye distance vision improved, but when reading, ghost images appeared in right eye.The left eye vision dramatically became worse with blurred vision, starbursts, halos, inability to focus or read at both distance or up close.Large "floaters" appeared in my field of view and i had very poor vision without bright light.Second and third surgeries were performed on my left eye by dr.(b)(6) and a second surgery on my right eye was performed.The right eye near vision improved, but there was a slight degrading of distance vision.The left eye near vision has improved and i can now read without glasses, however, my night vision in my left eye is so bad that if i lose my vision in my right eye, i will not be able to drive at night.Severe dryness is also an issue, even with tear duct plugs in both eyes, continuous use of restasis solution twice daily and frequent use of artificial tears throughout the day.Hair and nails.

• Brand Name: CLEAR SIGHT KAMRA CORNEAL IMPLANT
• Type of Device: IMPLANT, CORNEAL REFRACTIVE
• Manufacturer (Section D): ACUFOCUS INC.
• MDR Report Key: 6910847
• MDR Text Key: 88146544
• Report Number: MW5072564
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 54