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

Model Number KS6985-0800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Ulcer (1796)

Event Date 03/20/2015

Event Type  Injury  

Event Description

On (b)(4) 2015, synergeyes received a complaint wherein the reason for return was ulcer.The report stated "the patient claims opened new vial because they had dropped the previous lens in the sink and didn't have time to clean.New lens was uncomfortable from start of wear however, the patient continued to wear the lens.Next day eye still hurt, patient went to urgent care facility." the ecp continues, "patient does have keratoconus in the os." ecp states that patient is blind in od.Ecp also claims, "the patient did not have any pain or irritation in eye from wearing original lens, but started to feel foreign body sensation and pain immediately following insertion of the 2nd lens and was diagnosed with corneal ulcer two days later." the report claims that discontinuation of the lens, antibiotic drops, artificial tears, oral pain medication, and use of sunglasses is all therapeutic treatment.The ecp is not specific as to which antibiotic drops were prescribed.Finally it is indicated that although the ulcer has resolved, a secondary complication "small corneal scar inferior to visual axis in os" arose.Between (b)(6) 2015 three (3) attempts were made to contact the ecp.On (b)(6) 2015, contact was made with the attending physician and the following information was obtained: ecp is unsure whether medication was prescribed at urgent care facility.Vigamox was the antibiotic treatment administered.Ecp is unsure of the oral pain medications dispensed.Ulcer has cleared and patient has a small residual corneal scar interior to visual axis.Patient has returned to lens wear using the replacement lens with no issues.

Manufacturer Narrative

During the investigation the following information 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.During surface inspection, the lens was able to wet properly and although two known issues were identified, both passed the manufacturing specifications and are unlikely to have contributed to the alleged injury.No correlation was found between the alleged injury and the device history report.

• Brand Name: SYNERGEYES HYBRID CONTAC LENS
• Manufacturer (Section D): SYNERGEYES, INC.; carlsbad CA
• Manufacturer Contact: karen kincade ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 4768329
• MDR Text Key: 5776424
• Report Number: 3005087645-2015-00004
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2020
• Device Model Number: KS6985-0800
• Device Lot Number: 062909
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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