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

Model Number CK25S-0050

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Abrasion (1789)

Event Date 03/20/2014

Event Type  Injury  

Event Description

On 2014 synergeyes received a complaint wherein the patient experienced a "foreign body" sensation while wearing the contact lens.Synergeyes contacted (b)(6) od, the attending (b)(6) at the university eye associates on (b)(6) 2014 determined the following additional information.On approximately (b)(6) 2014, the patient contacted the (b)(6) and stated that the contact lens was uncomfortable.The patient was instructed by the ecp to discontinue the use of the lens.The patient was not seen by the ecp.On approximately (b)(6) 2014, the patient again reported discomfort while wearing the contact lens.The ecp again instructed the patient to discontinue the use of the lens.The patient was not seen by the ecp.The patient was examined by the ecp on (b)(6) 2014 wherein the patient was found to have a small superficial punctate keratopathy (spk) and minor staining in th e left eye.There was no abrasion or other corneal defect detected during the examination.The lens was inspected by the ecp who determined that there was a "fracture in the lens material." the ecp advised the patient to discontinue the use of the contact lens and undergo treatment.Patient treatment consisted of discontinuing the use of the lens and wearing an "air-optix day and night" bandage over the left eye for 24 hours.The patient has a pre-existing condition (keratoconus) which may have contributed to the event.Also the patient wore the fractured contact lens after being advised to discontinue the use of the lens.On (b)(6) 2014, the patient was seen by the ecp.The patient was doing "fine" and the spk healed.

Manufacturer Narrative

During the investigation the following information was obtained: lens surface was inspected using an optical microscope.There was significant debris/film of optic; indicative of wear for several days/weeks.Minor clouding of skirt indicative of wear for several days/weeks.Significant (3-4 mm) tear in the skirt proximal to gp junction - indicative of wear for several days/weeks and indicative of damage by the patient or ecp damage is consistent with pinching the lens too hard during removal; damaging the lens.

• Brand Name: SYNERGEYES HYBRID DAILY 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: 3827845
• MDR Text Key: 4451813
• Report Number: 3005087645-2014-00011
• Device Sequence Number: 1
• Product Code: HQD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061120
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Model Number: CK25S-0050
• Device Lot Number: 055056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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