ORTHOKERATOLOGY, CRT CONTACTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for ORTHOKERATOLOGY, CRT CONTACTS manufactured by Unk.

Event Text Entries

[128863104] My son age (b)(6), has acanthamoeba keratitis after wearing crt contacts. Orthokeratology contacts that were presented by an optometrist. My son initially wore glasses, then soft, 2 weeks contacts. He was presented with the crts as a good candidate for this procedure. He has worn them for the last 2 + years. He was prescribed to sleep in them to correct his vision, take them out the next morning to have 20/20. As a parent who paid for the contacts, i read what i could about the contacts and couldn't find any reason not to have my son try wearing these. I never found any articles that gave me enough info as the risks of crts. After wearing them for a year, his eyes were irritated and we went back into the office where he was prescribed the crts, he was told they needed polishing every 3 months for which we were never informed. His eyes would get dry from time to time but nothing that seemed out of the ordinary until (b)(6) of this year when he complained his eyes were so dry he couldn't see. We went back to the optometrist who then examined him and said he had "pinkeye". My son told him his eyes were irritated and the solution and bothering his eyes and so he added tap water to the solution. This was never a red flag. His eyes were not filled with puss, like i expected with pinkeye. He had never had "pinkeye" before. My son was given antibiotic drops. After 4 days we sent to the pediatrician to see if we were doing the right course, he suggested that if the antibiotic drops weren't working then it must be viral. We went back on the (b)(6) to the optometrist. After 2 weeks of going back and forth to the optometrist and talking with our pediatrician's office to let them know we were still dealing with an infection, i then sought on my own a visit to an ophthalmologist, (b)(6), who after examination sent us directly to the cornea specialist as he suspected acanthamoeba. My son wasn't treated for acanthamoeba keratitis until it was confirmed by the culture that was sent off from the cornea specialist. They had taken photos through confocal microscopy but couldn't i see anything at the time due to my son's eye being so irritated. This is a very tough diagnosis for anyone much less a (b)(6) who could have avoided this infection. The optometrist and the pediatrician's office never suspected this infection and treated it without severity. We had not been informed about "not sleeping in contacts" and "staying clear of water around contacts. " the public needs to be fully aware of this potential risks. The optometrist should contact us with any medical news of risks, along with the pediatrician's office be alerted to the risks contacts have. For now, my son spends days and nights in the dark with hourly drops, and has missed almost 2 months of school and has lost vision in his left eye. He also has endured excruciating pain. This needs to be reported and stopped. Crts should never be sold. Contact risks need to be out there for the public. I can't tell you how many i have told this story to that have said they swim, shower, and sleep in contacts. Sincerely, a very upset mom having been introduced to acanthamoeba keratitis. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081675
MDR Report Key8111074
Date Received2018-11-27
Date of Report2018-11-26
Date of Event2018-10-04
Date Added to Maude2018-11-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameORTHOKERATOLOGY, CRT CONTACTS
Generic NameLENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT
Product CodeNUU
Date Received2018-11-27
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameORTHOKERATOLOGY, CRT CONTACTS
Generic NameLENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT
Product CodeNUU
Date Received2018-11-27
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2018-11-27

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