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

Model Number SA79F+0775

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Ulcer (1796)

Event Date 04/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, synergeyes consultation received a call from dr.(b)(6) regarding a pt who sustained a corneal ulcer on the os while wearing a synergeyes contact lens.Dr.(b)(6) was contacted by synergeyes on (b)(6) 2014 for additional event info.On (b)(4) 2014, ordered sa79f+0775 (os) for the pt.The lenses were shipped to the practice on (b)(6) 2013 and were dispensed by dr.Post dispensing the pt felt that the os lens was irritating the left eye, but continued to wear the lens for the 20/30 visual acuity the lens provided.Dr.(b)(6) saw the pt approx 1 week after dispensing the lens.The pt wore the lens to the examination and the lens remained on the pt during the visual examination.Dr.(b)(6) stated that the os eye locked irritated, but no abrasion was indicated during the visual examination.The pt was instructed to discontinue the use of the lens until symptoms subsided.On (b)(6) 2014, the pt returned to the practice still wearing the os lens.Dr.(b)(6) stated that the pt continued to wear the lens even after being advised to discontinue the use of the lens.During the subsequent visual examination dr.(b)(6) discovered a minor corneal ulcer on the pt's os; para-center and interior, with abrasions around the ulcer.Dr.(b)(6) stated that in response to the lens irritating the left eye, the pt rubbed the eye to relieve the irritation.The pt demonstrated the rubbing "technique" which consisted of putting pressure on the lens and vigorously rubbing the lens eye.Dr.(b)(6) further stated that this rubbing technique likely irritated the left eye, ultimately causing the ulcer.Dr.(b)(6) instructed the pt to discontinue the use of the lens and prophylactically prescribed ciloxan to treat the ulcer.Dr.(b)(6) concluded that the lens contributed to the event as cascading effect; if the pt had not worn the lens, the eye would not have been irritated, causing her to rub her eye.

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 radioscope.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: 3775827
• MDR Text Key: 4433715
• Report Number: 3005087645-2014-00008
• 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: 04/08/2014

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: 10/07/2018
• Device Model Number: SA79F+0775
• Device Lot Number: 054107
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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