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

Model Number CK25M-0475

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Abrasion (1789)

Event Date 07/09/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, synergeyes received a complaint wherein the patient (pt) sustained a corneal abrasion.Report stated: abrasion occurred in the left eye (os) a half hour after pick up.Pt was instructed to discontinue use of lenses and see ecp in two days' time.At the follow up appointment, dr.Stated "bearing could have caused abrasion." on (b)(6) 2014, synergeyes attempted to contact the practice and a message was left with (b)(6) to have a contact lens dept rep return the call.On (b)(6) 2014, synergeyes received a call from (b)(4), the following info was obtained: by "bearing in the lens" the doctor meant that the lens fit too tightly.

Manufacturer Narrative

During the investigation the following info was obtained: lens 1: lot: 058827, part number: ck25m-0475.Base curve was measured by radius scope and power was measured by lensometer.Both bc and power were found to be within specs.Although deposits and smudges were noted on surface, both were removed by saline and were most likely due to regular pt use.No correlation was found between the alleged injury and the device history report.Lens 2: lot: 058827, part number: ck25m-0475.Base curve was measured by radius scope and power was measured by lensometer.Both bc and power were found to be within specs.Although deposits and smudges were noted on surface, both were removed by saline and were most likely due to regular pt use.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 ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 4057965
• MDR Text Key: 16177187
• Report Number: 3005087645-2014-00020
• 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: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/01/2019
• Device Model Number: CK25M-0475
• Device Lot Number: 058827
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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