MAUDE Adverse Event Report: EUCLID SYSTEMS CORP. ORTHOKERATOTIC CONTACT LENS; LENS, CONTACTS

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 05/21/2019

Event Type  Injury  

Event Description

My son had been using orthokeratotic contact lenses for about 3 months when one side cracked and broke in the case.We returned and replaced that side, but a few days later on (b)(6) 2019 the other contact broke while in his eye.I (his mom and a physician) had helped him insert it when it was fully intact, but within a couple of minutes he was in alot of pain and asked me to take it out.When i removed the contact lens, only 2/3 of it was present and i could not locate the other 1/3.It was night time and my husband (another physician) and i looked throughout his eye cavity and could not find the missing piece, yet it still hurt him.The next day, we finally found the missing/broken piece of the contact lens in his eye, which had migrated toward his nasolacrimal duct.There were no lasting consequences because we were able to remove it quickly, but i am very concerned that the product is defective given that both sides broke within 3 months with regular use, and it is very dangerous that it broke inside his eye.I believe the outcome would have been worse had he not had 2 doctors attending to him right away.Fda safety report id# (b)(4).

• Brand Name: ORTHOKERATOTIC CONTACT LENS
• Type of Device: LENS, CONTACTS
• Manufacturer (Section D): EUCLID SYSTEMS CORP.
• MDR Report Key: 8855788
• MDR Text Key: 153342508
• Report Number: MW5088662
• Device Sequence Number: 0
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 41