ORTHOKERATOLOGY LENS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-17 for ORTHOKERATOLOGY LENS * manufactured by Unk.

Event Text Entries

[20885428] Rptr believes they have been the victim of possible damage to the cornea of the eye resulting from overnight wear of gas permeable contact lenses for the purpose of performing orthokeratology. Rptr is monocular and has been since the age of 8 when an accident took the sight in left eye and later took the eye itself. Rptr wears a prosthesis. Rptr has also been nearsighted since the age of 13 and this has progressed gradually over the years, although it has been corrected effectively by the wearing of eyeglasses. Since the approx age of 45 rptr has also needed reading glasses. A few years ago rptr found that they also needed a mid-range correction and, as a result, was wearing tri-focal lenses which were extremely annoying. About this time rptr contacted optometrist regarding lasik, which was being heavily promoted at the time. Optometrist quickly explained that although the process has very little risk, that it was still considered to be too risky for a monocular pt. After hearing the details, rptr agreed. Optometrist then told rptr about a "new" treatment that was so safe that it was even used on people like them and went on to describe orthokeratology, called "pcm" or "precise corneal molding" which they stated was from the co who had developed it. Rptr had tried and failed to be able to wear even a soft contact lens in the past. Rptr questioned ability to wear the lens the 4 to 8 hrs a day recommended to achieve the desired result. Rptr was told that the invention of a new gas permeable lens had increased the comfort so much that even rptr should be able to wear it. Rptr started the treatment and the results were immediate and exhilarating. However, rptr had suspected, the lens proved to be very uncomfortable to the extent that they were often only able to wear it for an hr or two a day. At this point the dr suggested wearing the lens at night while sleeping. Dr said that unlike previous hard contact lenses, the gas permeable lens was approved for this sort of wear. Indeed, from the start of the process rptr was told that, once they had achieved optimum correction, rptr would maintain this by wearing the lens every second or third night while sleeping and would have 20/20 vision in between. Rptr experienced no discomfort wearing the lens at night except extreme dryness in the morning when awakening. A couple of times the lens "stuck" to cornea but rptr had been warned about this and by hydrating eye with artificial tears it would shortly become "unstuck". The change in vision was phenomenal. Within 3 months rptr was nearly to 20/20 and still improving. Rptr continued to wear the lens at night all through this period. At this point in the treatment was when rptr started to experience the double vision. It manifested itself as a quite well defined "ghost" image above or to either side of the real one. It occurred at all times of the day or night but was most worrisome at night, or in low light situations. Called the dr immediately and was given an appointment the next day. After the examination, rptr was told that although they had now achieved 20/20 corrected vision, that there was a problem with the centering of the lens that could be corrected with a lens adjustment. Rptr was told to continue to wear the present lens until a new one could be ordered. It took almost a week to get the new lens and it did not seem to help. This process was repeated several times (3 or 4) to no avail. Rptr had 20/20 vision acuity without glasses, but with a devastating double vision that was almost unbearable to deal with. After consulting with people from pcm the dr finally admitted that dr was stumped and recommended abandoning the procedure. Dr said that as sight reverted back to its original nearsightedness that the double image should go away. And, slowly, it seemed to do just that. After about a month and 3 ever stronger lens changes, sight stabilized and the double vision seemed to be gone. Rptr was both relieved and disappointed. The ordeal seemed to be over except for some annoying problems at night while driving. Bright lights and reflective signs seemed to be blurring or have a hazy starburst around them. Consulted with the dr and dr responded with changing prescription which did not help. Dr finally told rptr that this is sometimes a symptom of aging and they might just have to learn to live with it as many other people do. Rptr kept wanting to make a connection with the orthokeratology. To make matters worse the problem seemed to be progressive, and after 6 or 8 months, it had become clear that the double vision had never completely gone away. Rptr now had a second ghost image above the real image for about 1/3 of its height in any low light situation (i. E. , night driving, movie theaters, dimly lit rooms, television viewing, dimly lit restaurants and many more). The scary thing is that it still seems to be getting worse over time. When rptr approached the optometrist with suspicion that the problem was related to the orthokeratology, optometrist became defensive and stated that they thought the problem was coincidental and they did not believe that it was connected in any way. At this point, rptr consulted an ophthalmologist, and after a complete examination was told that the lens and retina were in excellent condition with no signs of deterioration at all. A retinal topography scan was performed which showed a bow tie shaped bulge located so the knot area would be centered on pupil and angled across the cornea at about a 45% angle. It was the opinion of the ophthalmologist that this was the cause of double vision. Explanation was that when the pupil opening increased in size, as in a low light situation, that the distortion of the cornea was exposed and as a result produced the double vision (as rptr is sitting at the computer they are having to sort out words from a double image). Continued in b6.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1018683
MDR Report Key274073
Date Received2000-04-17
Date Added to Maude2000-04-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHOKERATOLOGY LENS
Generic NameGAS PERMEABLE CONTACT LENS
Product CodeMUW
Date Received2000-04-17
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key265288
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
10 2000-04-17

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