FDA Public Health Advisory:
Retinal Photic Injuries From
Operating Microscopes During Cataract Surgery
To: Ophthalmologists October 16, 1995
Cataract Centers
This message from the Food and Drug Administration (FDA) is to remind you about the
potential retinal hazards from operating microscopes, to review steps that can be taken to
minimize the risks of retinal photic injury from operating microscopes, and to make sure
physicians are aware of medical device reporting.
Background
Retinal photic injury from an operating microscope was first reported in 1983. (1) Since that
time, incidents of retinal photic injuries from operating microscopes continue to be reported
sporadically. (2-16) While the majority of injuries produce minimal symptoms, scotoma and
permanent central vision loss have occurred in some patients. (11) As is true with all
photochemical damage, clinical abnormalities are not evident immediately. Retinal edema or
mild pigmentary changes are typically discernable within one to two days after exposure and
varying degrees of pigmentary modeling become more apparent after one to three weeks. (18)
Incidence of Injuries
The incidence of serious injury is not known, as is illustrated by the following studies, but
significant permanent vision loss appears to be infrequent. A recent prospective study at a
training institution found retinal photic injury from an operating microscope in 28% of patients.
(11) In this study a microscope was used with relatively intense light and exposure times of 20
to 120 minutes. This study also demonstrated a dose-response relationship; the risk of retinal
damage increased with increasing retinal exposure to the light from operating microscopes.
Another prospective study, performed at a different institution with an operating microscope that
provided about 28% lower corneal irradiance levels and shorter exposure times (21 to 76
minutes), reported no retinal photic injuries. (16) Preoperatively, patients had detailed ocular
examinations and , when possible, fundus photography and oral fluorography. Fluorescein
angiography was performed after cataract surgery to identify the most subtle retinal photic
injuries that may have occurred. In two additional retrospective studies, the incidence of retinal
photic injuries was 7% and 3%. (8, 17)
Risk Factors
Despite all efforts taken to minimize the risks of retinal damage, retinal photic injuries from the
light source used in operating microscopes during cataract surgery and other intraocular
procedures may occur. Several factors appear to be important determinants of photic retinal
injury. These include: angle of light incidence, light intensity, exposure time, and intensity of
the blue light component.
Actions to Reduce the Risk of Retinal Photic Injury
The following actions may reduce the risk of retinal photic injury from operating microscopes
during cataract surgery:
Use only that light intensity needed to clearly visualize and perform the surgical
procedures.
Do not assume that the intensity of the light from all operating microscopes is the same.
Some are brighter than others. When using a new microscope, visually evaluate and set
light levels to the lowest levels successfully used in the past.
Replace lamps only with manufacturer-approved products.
Because blue light has been shown to be more toxic than longer-wavelength light, the
addition of a filter to exclude light below about 515 nm has been recommended, to
eliminate blue light, especially in cases requiring prolonged light exposure. (18)
However, a 515 nm short wavelength cut-off filter will result in a yellow light. Cut-off
filters at wavelengths shorter than 515 nm to about the range of 420 - 435 nm will affect
the color rendition of the light less and may still provide useful reduction in the risk of
injury.
Use oblique lighting if it is available, or otherwise shield the pupil when the red reflex is
not required or the operating field permits. Oblique lighting may be used during phases
of an operation that do not require coaxial light.
Minimize direct exposure to the fovea.
Educate residents about the above actions in order to help reduce the risks of retinal
photic injury during training programs and in the future.
Standards Efforts
The American National Standards Institute (ANSI) is developing a proposed product
performance standard that will be applicable to the manufacturers of operating microscopes used
in ophthalmic surgery. This proposed standard will incorporate engineering, labeling, and user
information requirements that are intended to make the device safer to use and the user aware of
ways to minimize the risks associated with the use of the operating microscope during ocular
surgery.
Reporting Requirements for Retinal Photic Injury Incidents
Although retinal photic injury from operating microscopes during cataract surgery is not a new
phenomenon, some physicians may not be aware of the reporting requirements of the Safe
Medical Devices Act of 1990 (SMDA). Prompt and accurate reporting by practitioners will help
make it possible to obtain a better estimate of the incidence of retinal photic injury from
operating microscopes during cataract surgery and other intraocular procedures.
The SMDA requires hospitals and other user facilities to report deaths, serious illnesses and
injuries associated with the use of medical devices. The procedures established by your facility
for such mandatory reporting should be followed. Practitioners who become aware of any
medical device related adverse event or product problem/malfunction should report to their
Medical Device User Facility Reporting person.
Even if an incident is not required to be reported under the SMDA, it would be helpful to report
directly to MedWatch, the FDA's voluntary reporting program. Submit these reports to
MedWatch: by phone at (800)FDA-1088, by FAX at (800)FDA-1078, or mail to:
MedWatch
Food and Drug Administration
HF-2
5600 Fishers Lane
Rockville, Maryland 20857.
If you have any question regarding this Public Health Advisory, please contact Robert J. Landry,
Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug
Administration, HFZ- 134, 1901 Chapman Avenue, Rockville, Maryland 20857; or by FAX at
(301)443-2263.
Sincerely yours,
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
REFERENCES:
1. Berler, D.K., and Peyser, R.: Light intensity and visual acuity following cataract surgery.
Ophthalmology, 90:933, 1983.
2. McDonald, H.R., and Irvine, A.R.: Light induced maculopathy from the operating
microscope in extracapsular cataract extraction and intraocular lens implantation.
Ophthalmology, 90:945, 1983.
3. Boldrey, E.E., Ho, B.T., and Griffith, R.D.: Retinal burns occurring at cataract extraction.
Ophthalmology, 91:1297, 1984.
4. Delaey, J.J., de Wachter, A., Van Oye, R., and Verbraeken, H.: Retinal phototrauma during
intraocular lens-implantation. Int. Ophthalmol., 7:109, 1984.
5. Hupp, S.L.: Delayed, incomplete recovery of macular function after photic retinal damage
associated with extracapsular cataract extraction and posterior lens insertion (correspondence).
Arch. Ophthalmol., 105:1022, 1987.
6. Johnson, R.N., Schatz, H., and McDonald, H.R.: Photic maculopathy. Arch. Ophthalmol.,
105:1633, 1987.
7. Khwarg, S.G., Geoghegan, M., and Hanscom, T.A.: Light-induced maculopathy from the
operating microscope. Am. J. Ophthalmol., 98:628, 1984.
8. Khwarg, S.G., Linstone, F.A., Daniels, S.A., Isenberg, S.J., Hanscom, T.A., Geoghegan, M.,
and Straatsma, B.R.: Incidence, risk factors and morphology in operating microscope light
retinopathy. Am. J. Ophthalmol., 103:255, 1987.
9. Lindquist, T.D., Grutzmacher, R.D., and Gofman, J.D.: Light-induced maculopathy.
Potential for recovery. Arch. Ophthalmol., 104:1641, 1986.
10. Ross, W.H.: Light-induced maculopathy. Am. J. Ophthalmol., 98:488, 1984.
11. Byrnes, G.A., Antosyzk, A.N., Mazur, D.O., Kao, T.C., and Miller, S.A.: Photic
Maculopathy after extracapsular cataract surgery. A prospective study. Ophthalmology, 99:731,
1992.
12. Brod, R.D., Barron, B.A., Suelflow, J.A., Franklin, R. M., and Packer, A.J.: Phototoxic
retinal damage during refractive surgery. Am. J. Ophthalmol., 102:121, 1986.
13. Cech, J.M., Choromokos, E.A., and Sanitato, J.A.: Light-induced maculopathy following
penetrating keratoplasty and lens implantation (correspondence). Arch. Ophthalmol., 105:751,
1987.
14. Stamler, J.F., Blodi, C.F., Verdier, D., and Krachmer, J.H.: Microscope light-induced
maculopathy in combined penetrating keratoplasty, extracapsular cataract extraction, and
intraocular lens implantation. Ophthalmology, 95:1142, 1988.
15. McDonald, H.R., and Harris, M.J.: Operating microscope-induced retinal phototoxicity
during pars plana vitrectomy. Arch. Ophthalmol., 106:521, 1988.
16. Byrnes, G.A., Chang, B.,, Loose, I., Miller, S.A., Benson, W.E.: Prospective incidence of
photic maculopathy after cataract surgery. Am. J. Ophthalmol., 119:92, 1995.
17. Gomolin, J.E., and Koenekoop, R.K.: Presumed photic retinopathy after cataract surgery: an
angiographic study. Canadian J. of Ophthalmol., 221:4, 1993.
18. Davidson, P. and Sternberg, P., Jr.: Potential Retinal Phototoxicity. American J. of
Ophthalmology, 116:4, 1993.
Updated September 27, 1995
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