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

Model Number KS6582-1200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Infiltrates (2231); No Code Available (3191)

Event Date 06/19/2014

Event Type  Injury  

Event Description

On (b)(4) 2014, synergeyes received a complaint wherein the pt (pt) sustained corneal erosion.Report stated: "infiltrate or nodule at the junction site of contact lens (cl)".The alleged injury resolved with a prescription of zylet.The pt has a pre-existing condition of keratoconus, and though there was allegedly irritation pt continued to wear the lens."unaware the lens could be defective".On (b)(4) 2014, synergeyes attempted a good faith effort to obtain further info from laura hardy, an office attendant for eyesight ophthalmic services, by phone and a message was left on voicemail.On (b)(4) 2014, synergeyes attempted to contact laura hardy again, unsuccessfully.

Manufacturer Narrative

During the investigation the following info was obtained: base curve was measured by radius scope and power was measured by lensometer.Both bc and power were found to be within specifications.Although an irremovable deposit and minor scratches were found on the surface of the lens, this is most likely due to long-term pt use.Upon return, it was determined that the lens had been worn two months beyond the recommended life expectancy of 6 months and was beyond the warranty date.No correlation was found between the alleged injury and the device history report.

• Brand Name: SYNERGEYES HYBRID CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES, INC.; carlsbad CA
• Manufacturer Contact: karen kincade, director ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3954587
• MDR Text Key: 4605749
• Report Number: 3005087645-2014-00018
• 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: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• 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: KS6582-1200
• Device Lot Number: 053734
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2013
• 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