MAUDE Adverse Event Report: SYNERGEYES, INC. SYNERGEYES HYBRID DAILY CONTACT LENS

Model Number KS6585-0750

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Abrasion (1789)

Event Date 03/21/2014

Event Type  Injury  

Event Description

On (b)(4) 2014 synergeyes received a complaint from (b)(6) regarding pt with keratoconus who had sustained a corneal abrasion/edema while wearing synergeyes contact lenses.The (b)(6) was contacted on (b)(4) 2014 for additional event info.In response to os irritation, the pt went to ophthalmologist dr (b)(6).Dr (b)(6) treated the pt's symptoms as an infection.Moreover, dr (b)(6) stated that the irritation was lens related and sent the pt back to vision source for a follow up.Vision source did not have any additional info regarding date, treatment, or medications administered by dr (b)(6).On (b)(6) 2014 the pt was seen by (b)(6) for a follow up with dr (b)(6) who instructed the pt to discontinue use of the lens.Dr (b)(6) then advised the pt to change their storage and cleaning solution to clearcare to eliminate it as the source of the os irritation.Dr (b)(6) stated in the pt's record that the irritation and subsequent corneal abrasion/ edema were due to apical touching of the os lens on the cornea.On (b)(6) 2014 on further issues.

Manufacturer Narrative

During the investigation the following info was obtained: lens surface was inspected using an optical microscope.No surface defects were detected.Base curve was measured using a radiuscope.The lens' measured parameter was within the lens design specification.Power was measured using a lensometer.The lens' measured power was within the lens design specification.

• Brand Name: SYNERGEYES HYBRID DAILY CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES, INC.; carlsbad CA
• Manufacturer Contact: karen kincade ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3848414
• MDR Text Key: 4684005
• Report Number: 3005087645-2014-00009
• Device Sequence Number: 1
• Product Code: HQD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2018
• Device Model Number: KS6585-0750
• Device Lot Number: 052266
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention