MAUDE Adverse Event Report: SYNERGEYES SYNERGEYES HYBRID CONTACT LENS - KS

Model Number KS6785-1450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Ulcer (1796)

Event Date 03/20/2014

Event Type  Injury  

Event Description

On (b)(4) 2014, synergeyes received a complaint wherein pt sustained a corneal ulcer in the right eye (od).Pt also experienced "slight irritation." attending eye-care professional (ecp) prescribed tobradex for symptoms in the left eye (os).Complaint states that symptoms surfaced (b)(6) 2014, however "all symptoms have been resolved as of now." wherein, "now" refers to (b)(6) 2014.From (b)(6) 2014, several attempts were made to obtain additional event information from ecp.On (b)(6) 2014, synergeyes spoke with dr (b)(6) regarding the event and pt.The following was disclosed: pt has a history of over wearing lenses.For example: pt wore last set of synergeyes lens for longer than one year, when the recommended length is 6 months, the lenses mentioned were ordered (b)(6) 2009.New lenses ordered in the same parameters on (b)(6) 2014 were uncomfortable for pt and pt developed redness and irritation with pain greater in od than in os.At a follow up visit, pt exhibited a "mechanical" sterile ulcer in the right eye just outside the junction.This cleared completely with treatment.A technician from the ecp practice called synergeyes consultation on (b)(6) 2014 and inquired about os lens turning eye "red." synergeyes consultant instructed lab tech to switch lenses to see if problem followed lens to od or remained only in os.As instructed by dr (b)(6) this was never done.Instead, dr (b)(6) returned lenses and reordered the same prescription (rx) for both eyes, to verify if original lenses were "bad".Os rx was ordered on (b)(6) 2014 and od rx on (b)(6) 2014.Pt is doing well with new lenses for both eyes.

Manufacturer Narrative

Second device returned: model # ks6785-1550, lot #: 052049, expiration date: 06/01/2018, manufacture date: 07/01/2013.During the investigation, the following information was obtained.Device 1: base curve measured by radius scope and power measured by lensometer, both bc and power were found to be within specifications.No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history.Device 2: base curve measured by radius scope and power measured by lensometer.Both bc and power were found to be within specifications.No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history.

• Brand Name: SYNERGEYES HYBRID CONTACT LENS - KS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES; carlsbad CA
• Manufacturer Contact: karen kincade, director ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3883639
• MDR Text Key: 4565747
• Report Number: 3005087645-2014-00014
• Device Sequence Number: 1
• Product Code: HQD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051035
• 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: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: KS6785-1450
• Device Lot Number: 056131
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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