MAUDE Adverse Event Report: SYNERGEYES SYNERGEYES HYBRID CONTACT LENS

Model Number CK10S+0650

Device Problem Use of Device Problem (1670)

Patient Problem Corneal Ulcer (1796)

Event Date 02/06/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, synergeyes received a complaint wherein the reasons for return were "corneal ulcer" and "defective".Report stated, "two lenses stuck together" and attempted to describe how this occurred, "patient had lens in eye for two weeks and unaware - took lens out." also included was that the patient noticed a bump under upper lid due to irritation for two days.Treatment indicated was therapeutic vigamox, which had resolved the issue with no secondary complications by the date of the report.On (b)(6) 2015, synergeyes contacted ecp and the following information was obtained: ecp confirmed ulcer occurred.Stated that patient wore two lenses in the affected eye at the same time.This is not a recommended procedure.Also stated patient was unaware first lens had been in eye upon insertion of second lens.Lenses torn upon removal.

Manufacturer Narrative

Our review of the device history record of the reported lens did not indicate any issues that would have contributed to an injury of this nature without the patient using two synergeyes lenses in one eye, which is not a recommended procedure.Although lenses were returned, they were not accompanied by any paperwork.The relevant paperwork was returned at a later date and by the time the paperwork arrived, the lenses had been discarded by the returns department.There was no indication on any received packaging that the lenses were related to any injury.

• Brand Name: SYNERGEYES HYBRID CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES; carlsbad CA
• Manufacturer Contact: karen kincade ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 4663455
• MDR Text Key: 17934662
• Report Number: 3005087645-2015-00003
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: CK10S+0650
• Device Lot Number: 061674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2014
• 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