MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-05-09 for TONOMETER manufactured by .
[21947775]
No complaints of this nature have been received from any other customers. It is clear from the information given by the users that the cleaning and disinfection process being used differs from the keeler instructions in a number of areas: only the tip is immersed, prism face down in the solution. The prisms are not adequately rinsed prior to drying; the prisms were not inspected for cracks or chips prior to use on the patient(s). From the testing conducted at keeler during this investigation we have concluded that processing the keeler applanation tonometer prisms using 3% hydrogen peroxide solution, and following the user instructions will have no detrimental effect on the prism, and is therefore deemed safe and appropriate for use. The damage to the prism surfaces and subsequent reversible injures sustain by the patients have been caused by a combination of improper cleaning and disinfection techniques and a failure on the part of the user to ensure the condition of the prism was appropriate for continued use as specified in the user instructions.
Patient Sequence No: 1, Text Type: N, H10
[22042565]
Leaking or cracked tonometer prism tip takes up small amounts of disinfectant solution while cleaning, which is then released onto the patients eye when next used. This solution irritates the patients eye or causes reversible corneal scarring. Reporter's own words; "i recently got a tonometry tip and i have noticed that it leaks after i clean it. I have already left scars on two patients already and i am afraid of burning more patients. I need to be able to use a tonometry tip everyday so i was wondering if i could get a new one if i gave mine back. " "hi, i am writing in regards to my tonometer tip. I came in and spoke about it a few weeks ago now. Sorry for the delayed email but my tip has cracks in it and this is after proper use of the tip. It was correctly cleaned, i only soaked it in peroxide for the required 10 minutes and it was properly inserted, i never forced it onto the slit lamp. I would like a replacement because this is imperative for my clinical experience. " "unfortunately, i am having some issues with my tonometry tip. Over the past few weeks i've begun to notice progressive cracks on the applanation end of my tonometer. I understand that these cracks can lead to "tatoo-ing" of the patient's cornea as well as make tonometry readings difficult. The cleaning technique that i have been using is an 10 minute soak in 3% peroxide solution. Please let me know what my options for replacement are. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000391004-2013-00001 |
| MDR Report Key | 3131482 |
| Report Source | 08 |
| Date Received | 2013-05-09 |
| Date of Report | 2013-04-19 |
| Date Mfgr Received | 2013-04-18 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-07-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CLEWER HILL RD. |
| Manufacturer City | WINDSOR, BERKSHIRE SL4 4AA |
| Manufacturer Country | UK |
| Manufacturer Postal | SL4 4AA |
| Manufacturer Phone | 1753827153 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TONOMETER |
| Generic Name | TONOMETER |
| Product Code | HKY |
| Date Received | 2013-05-09 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-09 |