STAINLESS STEEL OCULAR SHIELD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for STAINLESS STEEL OCULAR SHIELD manufactured by Unk.

Event Text Entries

[105948502] Without asking me anything about my eye history before my co2 laser treatment of the face, the nurse told me she had to apply stainless steel ocular shields to protect my eyes, placing them directly on top of my eyeballs. This was without assaying my decade's worth of eye problems including allergic conjunctivitis with corneal erosions for which i had taken daily antihistamine eye drops, optive moistening drops, and sometimes prednisone. Unless eye numbing drops or prednisone drops were applied directly on the equipment without informing me, neither was used. (and if she used what i found out later was the standard "wool fat" lubricant, or lanolin, i would have been expected to react to it, along with the many people allergic to wool and sheep fur products. ) whatever the cause, i screamed from the immediate severe pain and demanded the shields be removed, which the nurse then struggled to do, yelling at me to open my lids all the way, an impossible task because by then my eyeballs were severely inflamed. She then rinsed my eyes with some solution, blotted them, and then right away applied stick-on pads over them for protection, acting quickly because the doctor was pressuring her, ready to start the co2 laser treatment. After the procedure was done a half hour later, i was still seeing deep blue color with sparkles under, y lids alternating with startling kaleidoscopic patterns. My eyes so swollen by then, i could barely crack my lid, and when i did, there was only darkness. I was put into a chair to recover, but given nothing for my horrible eye pain and loss of sight. Finally another half hour later - still unable to open my eyes and with no vision - the nurse again rinsed them with some solution. But still unable to see, i was sent home, my husband having to guide me out like a blind person with a prescription for an oral prednisone dose pack of (21) 5 mg pills to be taken over 6 days. By the time he got to the drug store to pick it up and get me to take the initial dose of 10 mg, it was a good 4 hours after the ocular shields had been inserted. After taking to bed for two more hours, i could finally start opening my eyes with much less pain and was beginning to see light and some color. Thankfully, my vision continued to improve to nearly normal by the next day. But my eyeballs continued aching for days and i felt my eyesight had been put at grave risk by the stainless steel ocular shields. Fda should put a black box warning on stainless steel ocular shields precluding physicians from using them on patients with chronic eye problems and/or eye allergies including conjunctivitis, history of irritation and/or erosions. They should also be prohibited from using them with lubricants that use the common allergan "wool fat," or lanolin. In addition, doctors treating with co2 laser should be black box warned to use numbing drops and/or prednisone drops without preservatives such as sulfates to which some nearly 10 percent of people are also allergic. I truly believe had i not insisted the stainless steel ocular shields be immediately removed, i would have risk permanently losing my sight. I could possibly now be blind.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076538
MDR Report Key7439640
Date Received2018-04-17
Date of Report2018-04-16
Date of Event2018-02-02
Date Added to Maude2018-04-18
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTAINLESS STEEL OCULAR SHIELD
Generic NameSHIELD, EYE, OPHTHALMIC
Product CodeHOY
Date Received2018-04-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-04-17

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