MAUDE Adverse Event Report: SYNERGEYES SYNERGEYES HYBRID DAILY CONTACTS - PS; CONTACT LENS

Model Number PS8886-0175L2/H.10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Abrasion (1789)

Event Date 04/28/2014

Event Type  Injury  

Manufacturer Narrative

Second device returned: model #: ps888-0550l2, lot #: 057235, expiration date: 03/01/2019.During the investigation, the following information was obtained: for device 1 (lot #046764) base curve (bc) measured using radius scope and power measured using lensometer, both bc and power were found to be within specifications.No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history.For device 2 (lot #057235) base curve (bc) measured using radius scope and power measured using lensometer, both bc and power were found to be within specifications.No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history.Conclusion: alleged corneal abrasion occurred during specified fitting period, possibly due to poor fit, and resolved with discontinuation of use.Attending ecp stated patient was using poor removal method, which may have contributed to the alleged injury.No defects were found and no correlation was found between the alleged injury and the lens processing history.

Event Description

On (b)(4) 2014, synergeyes received a complaint wherein the patient sustained a corneal abrasion leading to iritis in os and od.Complaint stated: upon removal of lenses, patient had extreme discomfort which, according to the attending ecp, is possibly due to a poor insertion and removal technique, the patient used.Severe pain and photophobia followed, the patient's "staff" physician applied an eye patch to the od.Origin of pain and photophobia was found to be a corneal abrasion with subsequent iritis.Thereafter, the patient discontinued use of "all" contact lenses.On (b)(6) 2014, synergeyes contacted "(b)(6)", an office attendant for doctors (b)(6), and obtained the following information: 1) patient started wearing lenses on a saturday at work before (b)(6) 2014 and experienced pain.An on-site physician applied an eyepatch to od.Patient saw attending ecp on (b)(6) 2014 when vigamox was prescribed.2) on (b)(6) 2014, patient returned to ecp with sore eyes, treated again with vigamox.The following day, (b)(6) 2014, patient tried to wear lenses again.Patient returned to ecp office on (b)(6) 2014 with same pain.Upon examination, attending ecp diagnosed patient with keratoconjunctivitis and iritis once again prescribing vigamox.3) attending ecp determined that the contacts in question were a tight fit and that the patient used a poor removal technique, which may have contributed to the injury.4) patient had lasik surgery in 1998, which is why the lenses were of the post surgery line of synergeyes products.

• Brand Name: SYNERGEYES HYBRID DAILY CONTACTS - PS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): SYNERGEYES; carlsbad CA
• Manufacturer Contact: karen kincade, director ; 2232 rutherford road; carlsbad, CA 92008 ; 7604449636
• MDR Report Key: 3874023
• MDR Text Key: 22211500
• Report Number: 3005087645-2014-00012
• Device Sequence Number: 1
• Product Code: HQD
• Combination Product (y/n): N
• PMA/PMN Number: K060102
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2017
• Device Model Number: PS8886-0175L2/H.10
• Device Lot Number: 046764/SEE H.10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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