MAUDE Adverse Event Report: SYNERGEYES SYNERGEYES HYBRID CONTACT LENS

Model Number DUH20M-0650

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 06/03/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, synergeyes received a complaint wherein a contact lens tech (clt) sustained a cut to his hand from opening a vial.Report stated: clt was opening the vial for the 200 vault lens from the ultra health (uh) diagnostic kit to fit the first patient when the top of the bottle, below the neck, cracked off in clt's hand and the raw glass cut his finger.On (b)(6) 2014, synergeyes left a message with (b)(4), an office attendant for eye essentials inc.To have clt call back.On (b)(6) 2014, clt called back and the following information was obtained.On (b)(6) 2014, the cap of the vial was not opening and when clt applied a little more torque with his dominant hand, the vial broke off below the neck; such that the cap, neck, and stopper broke off in one piece.The broken glass cut his right hand.No stitches or any other medical attention was needed, all symptoms of the event have resolved.The vial and accompanying lens have been disposed of as recommended by the synergeyes representative.

Manufacturer Narrative

Based on the fact that the lens and vial in question are from an ultra health diagnostic kit, synergeyes determined that the lens cold have been from one of three possible lots: 056400, 057419, 07452 and the vial could have been from two possible vial lots: rc03538 or rc03647.Lots, expiration dates, and manufacture dates: 057419; exp 03/01/2019; mfr date 04/16/2014.Lot 057452; exp 03/01/2019; mfr date 04/18/2014.The dhr was reviewed and no correlation was found between manufacture of product and events.Synergeyes has never had an occurrence of this type of event before.

• Brand Name: SYNERGEYES HYBRID CONTACT LENS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES; carlsbad CA
• Manufacturer Contact: karen kincade, dir ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3934998
• MDR Text Key: 4531453
• Report Number: 3005087645-2014-00016
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: DUH20M-0650
• Device Lot Number: 056400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• 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