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

Model Number AS7787-0075

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Edema (1791)

Event Type  Injury  

Event Description

On (b)(6)2014 synergeyes received a complaint from dr.(b)(6) regarding a pt who has keratoconus and meibomian gland dysfunction.It was reported that the pt's left eye sustained a corneal edema while wearing a synergeyes contact lens.The practice was contacted by synergeyes on (b)(6) 2014 for additional event info.The pt has been wearing the synergeyes contact lenses ordered through the (b)(6) center since 2010; the last order was shipped to the (b)(6) center on (b)(6) 2012.In (b)(6) 2013 the pt was seen by the dr.(b)(6) practice.New lenses were ordered by the practice using the pt's pre-existing prescription (ap7487-0075ct) changing the rx from an ap to an as and power from -0.75 to -0.50.The pt's k readings and topographical measurements were not taken at the time of the examination for the new lens order.On (b)(6) 2013 synergeyes shipped an as7487-0050 to the practice as a "first order" which was dispensed on (b)(6)2013.On (b)(6) 2013 synergeyes shipped an as7487-0075 to the practice as an "exchange prescription" and on (b)(6) 2013 the two pack completion set was shipped.The lenses were dispensed on (b)(6) 2013.Post dispensing and prior to the pt's office visit to the practice on (b)(6)2014, the pt's left eye became irritated.In an effort to diagnose the irritation the pt decided to remove the current lens and replace with the lens from the 2 pack completion; the irritation did not change.In response to the irritation, dr.(b)(6)instructed the pt to use warm compresses and optifree drops.The pt's wear schedule was changed to wear the lens for no more than 8 hours a day, with 1 hour breaks and only wear the lenses when the eyes are not red or irritated.The pt was seen by the practice on (b)(6) 2014 wherein dr.(b)(6) determined that the pt had acute conjunctivitis.The practice also stated that the pt had moderate grade conjunctiva hyperemia bulbar 2+, corneal edema, and stromal thinning.No meds were prescribed during the (b)(6) 2014 office visit.On (b)(6) 2014 the pt was seen by the dr.(b)(6) for a follow up.

Manufacturer Narrative

Two lenses were associated with the alleged injury.Lens 1.During the investigation the following info was obtained: lens surface was inspected using an optical microscope.No surface defects were detected.Base curve was measured using a radiuscope.The lens' measured parameter was within the lens design specification.Power was measured using a lensometer.The lens' measured power was within the lens design specification.Lens 2: model#: as7487-0075, lot#: 054921, expiration date: 11/16/2018.Manufacture date: 12/16/2013.During the investigation the following info was obtained: lens surface was inspected using an optical microscope.No surface defects were detected.Base curve was measured using a radiuscope.The lens' measured parameter was within the lens design specification.Power was measured using a lensometer.The lens' measured power was within the lens design specification.

• Brand Name: SYNERGEYES HYBRID DAILY CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES, INC.; carlsbad CA
• Manufacturer Contact: karen kincade ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3775826
• MDR Text Key: 4441392
• Report Number: 3005087645-2014-00010
• 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: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2018
• Device Model Number: AS7787-0075
• Device Lot Number: 052463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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