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

Model Number CK15M-0400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796)

Event Date 02/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, synergeyes received a customer complaint form stating that the patient suffered a corneal abrasion.The patient notified the doctor that the synergeyes contact lens had a chip on the edge.After noticing the chip, the patient removed the lens, replacing the lens with a previously worn contact lens.This action led to the subsequent abrasion/corneal ulcer on the patient's os.On (b)(6) 2014 synergeyes contacted family eye clinic to obtain additional information and was informed that the chip on the synergeyes lens did not cause the abrasion/corneal ulcer.Customer stated that the abrasion/corneal ulcer was a result of the patient inserting the previously worn lens.The patient was treated with zymaxid and oxyfloaacin on (b)(6) 2014.On (b)(6) 2014 the patient returned to family eye clinic.The physician stated that the patient showed signs of improvement with the condition resolving with treatment.The synergeyes lens was replaced with a new lens and is wearing the lens with no further issues.

Manufacturer Narrative

During the investigation the following information was obtained: lens surface was inspected using an optical microscope.The lens sustained a chip and tear in the lens skirt.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 92008
• Manufacturer Contact: karen kincade, director ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3750713
• MDR Text Key: 16800734
• Report Number: 3005087645-2014-00006
• 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: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2018
• Device Model Number: CK15M-0400
• Device Lot Number: 053459
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention